DOCSLIB.ORG

Protocol Alert

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Protocol Alert 14 Protocol Alert New clinical trials recently added to the National Cancer Institute’s database oncology-times.com • BRAIN/CNS TUMORS and Cyclophosphamide in Treating ENDOMETRIAL CANCER Phase: Phase II, Phase I Light Sedation or Intubated Patients with Stage I-III Triple- Levonorgestrel-Releasing Type: Treatment General Anesthesia in Reducing Negative Breast Cancer Intrauterine System with or without Age: 18 and over Complications and Length of Phase: Phase II Everolimus in Treating Patients with Trial IDs: SGN35-016, Hospital Stay in Patients With Brain Type: Treatment Atypical Hyperplasia or Stage IA NCI-2013-00461, NCT01874054 Cancer Undergoing Craniotomy Age: 18 to 70 Grade 1 Endometrial Cancer Phase: Phase IV Trial IDs: 2014-BRST-TNBC-LQT, Phase: Phase II Safety, Tolerability, and Efficacy of October 10, 2015 Type: Supportive care, Treatment NCI-2015-01416, STUDY00002467, Type: Biomarker/Laboratory analysis, TAK-659 in Adults With Relapsed • Age: 19 and over NCT02413320 Treatment or Refractory Acute Myelogenous Trial IDs: OSU-12161, NCI-2014- Age: 18 and over Leukemia (AML) 01110, 2014C0007, NCT02193568 Trial IDs: 2014-0944, Phase: Phase II, Phase I CERVICAL CANCER NCI-2015-00919, NCT02397083 Type: Treatment Pazopanib Hydrochloride and Age: 18 and over BREAST CANCER Topotecan Hydrochloride in Treating Trial IDs: C34002, NCI-2015-00064, Study to Evaluate the Efficacy and Patients with Stage IVB or Recurrent HEAD & NECK/ U1111-1163-2185, NCT02323113 Safety of Eribulin Mesylate in Cervical Cancer ORAL CANCER Combination With Pembrolizumab Phase: Phase II Photodynamic Therapy With HPPH A Study of Duvelisib in Combination Oncology Times in Subjects With Metastatic Triple- Type: Biomarker/Laboratory analysis, in Treating Patients With Squamous With Rituximab or Obinutuzumab in Negative Breast Cancer (mTNBC) Treatment Cell Carcinoma of the Oral Cavity Subjects With Previously Untreated Phase: Phase II, Phase I Age: 18 and over Phase: Phase II CD20+ Follicular Lymphoma Type: Treatment Trial IDs: 2014-0625, Type: Biomarker/Laboratory analysis, (CONTEMPO) Age: 18 and over NCI-2015-00211, NCT02348398 Treatment Phase: Phase II, Phase I Trial IDs: E7389-M001-218, Age: 18 and over Type: Biomarker/Laboratory analysis, NCI-2015-01436, KEYNOTE-150, Trial IDs: I 246513, NCI-2014-00756, Treatment NCT02513472 COLORECTAL CANCER NCT02119728 Age: 18 and over A Study Comparing the Efficacy and Trial IDs: IPI-145-19, Hypofractionated Regional Nodal Safety of RO5520985 and FOLFOX Surgery with or without Stereotactic NCI-2015-01462, Radiation Therapy in Treating Older With Bevacizumab and FOLFOX in Body Radiotherapy in Treating Patients NCT02391545 Patients with Breast Cancer Who with Previously-Irradiated Have Undergone Surgery Head and Neck Cancer Ruxolitinib Phosphate or Dasatinib Phase: Phase II Phase: Phase II with Chemotherapy in Treating Type: Biomarker/Laboratory analysis, Type: Treatment Patients with Relapsed or Refractory Treatment Age: 18 and over Philadelphia Chromosome-Like Age: 50 and over Trial IDs: 14-151, NCI-2015- Acute Lymphoblastic Leukemia Trial IDs: MCC-15-10994, 01424, NCT02516969 Phase: Phase II, Phase I NCI-2015-01317, NCT02515110 Type: Treatment Safety And Efficacy Age: 10 and over Panitumumab, Paclitaxel Albumin- Study Of Palbociclib Trial IDs: 2014-0521, Stabilized Nanoparticle Formulation, Plus Cetuximab Versus NCI-2015-00779, NCT02420717 and Carboplatin in Treating Cetuximab To Treat Head Patients with HER2-Negative And Neck Cancer Akt/ERK Inhibitor ONC201 in Primary Inflammatory Breast Phase: Phase II Treating Patients with Relapsed or Cancer Receiving Combination Type: Treatment Refractory Mantle Cell Lymphoma, Chemotherapy and Surgery Age: 18 and over Diffuse Large B-cell Lymphoma, or Phase: Phase II Trial IDs: A5481044, NCI- Transformed Large Cell Lymphoma Type: Biomarker/Laboratory analysis, 2015-01296, 2015-000515- Phase: Phase II, Phase I Treatment 41, NCT02499120 Type: Treatment Age: 18 and over Patients With Untreated Metastatic Age: 18 and over Trial IDs: 2008-0372, Colorectal Cancer (McCAVE) Azacitidine in Measuring Tumor Trial IDs: 2014-0630, NCI-2015- NCI-2012-00935, NCI-2010-02235, Phase: Phase II Response in Patients with HPV 00706, NCT02420795 NCT01036087 Type: Treatment Positive or Negative Head and Neck Age: 18 and over Squamous Cell Carcinoma That Can Tocladesine in Treating Patients with Metformin Hydrochloride in Trial IDs: BP29262, Be Removed by Surgery Relapsed or Refractory Acute Myeloid Reducing Treatment-Related NCI-2014-01282, Phase: Phase II Leukemia Neuropathy in Patients with Stage NCT02141295 Type: Treatment Phase: Phase II, Phase I I-IV Breast Cancer Undergoing Age: 18 and over Type: Biomarker/Laboratory analysis, Treatment with Paclitaxel Study of Pembrolizumab in Trial IDs: 1404013771, Treatment Phase: Phase II Combination With Chemotherapy NCI-2015-01437, 200 FR. 4 (2012-1), Age: 18 and over Type: Supportive care for Patients With Advanced NCT02178072 Trial IDs: 14269, NCI-2015-00871, Age: Over 18 Colorectal Cancer 116608, 120003, NCT02509546 Trial IDs: 2014-0438, Phase: Phase II NCI-2015-00510, NCT02360059 Type: Treatment LEUKEMIA/ An Efficacy and Safety Study of Age: 18 and over LYMPHOMA/MDS Decitabine (DACOGEN) Plus JNJ- Carboplatin and Docetaxel or Trial IDs: HCRN GI14-186, Study of Brentuximab Vedotin 56022473 (Anti CD123) Versus Carboplatin and Paclitaxel Followed NCI-2015-01466, Combined With Bendamustine in Decitabine (DACOGEN) Alone in by Doxorubicin Hydrochloride NCT02375672 Patients With Hodgkin Lymphoma Participants With Acute Myeloid 15 PROTOCOL ALERT Treating Patients with Advanced Trial IDs: HM-EMSI-202, NCI-2015- Cell Transplant in Treating Patients Oncology Times Continued from page 14 Refractory Solid Tumors or 01440, NCT02485652 With Multiple Myeloma Lymphomas Phase: Phase II Leukemia (AML) Ineligible for Phase: Phase II Type: Biomarker/Laboratory analysis, Intensive Chemotherapy Type: Biomarker/Laboratory analysis, MELANOMA Treatment Phase: Phase II Treatment Interleukin-12 Gene Electroporation Age: 18 to 72 Type: Treatment Age: 18 and over Therapy and Pembrolizumab in Trial IDs: 11-12-434, Age: 65 and over Trial IDs: EAY131, NCI-2015-00054, Treating Patients with Locally NCI-2013-01207, 11-102, Trial IDs: CR107273, NCI-2015-01326, EAY131-A, EAY131-B, EAY131-E, Advanced or Metastatic Melanoma NCT01605032 56022473AML2002, NCT02472145 EAY131-F, EAY131-G, EAY131-H, Phase: Phase II • EAY131-Q, EAY131-R, EAY131-U, Type: Biomarker/Laboratory analysis, Panobinostat, Gemcitabine October 10, 2015 Meloxicam and Filgrastim in EAY131-V, NCT02465060 Treatment Hydrochloride, Busulfan, and Collecting Peripheral Blood Stem Age: 18 and over Melphalan before Stem Cell Cells for Transplant in Patients With FLT PET/CT in Measuring Response Trial IDs: CC #15852, NCI-2015- Transplant in Treating Patients with Multiple Myeloma or Non-Hodgkin in Patients with Previously Untreated 01300, 133438, 15852, NCT02493361 Refractory or Relapsed Multiple Lymphoma Acute Myeloid Leukemia Myeloma Phase: Phase II Phase: Phase II Pembrolizumab, Standard Phase: Phase II Type: Treatment Type: Diagnostic, Treatment Chemotherapy, Tumor Infiltrating Type: Biomarker/Laboratory analysis, Age: 18 to 75 Age: 18 and over Lymphocytes, and High- or Low-Dose Treatment • oncology-times.com Trial IDs: IUCRO-0419, NCI-2014- Trial IDs: EAI141, Aldesleukin in Treating Patients with Age: 18 to 65 00470, NCT02078102 NCI-2015-00328, Metastatic Melanoma Trial IDs: 2014-0516, NCI-2015- NCT02392429 Phase: Phase II 01308, NCT02506959 Augmented Berlin-Frankfurt- Type: Biomarker/Laboratory analysis, Munster Therapy and Ofatumumab Donor Hematopoietic Stem Cell Treatment Sotatercept in Increasing Bone in Treating Patients with B-cell Transplant and Combination Age: 18 and over Mineral Density in Patients with Acute Lymphoblastic Leukemia or Chemotherapy as Initial Salvage Trial IDs: 2014-0922, NCI-2015- Multiple Myeloma with Complete Lymphoblastic Lymphoma Therapy in Treating Patients with 01395, NCT02500576 or Very Good Partial Response after Phase: Phase II Acute Myeloid Leukemia Refractory Previous Treatment Type: Treatment to High-Dose Cytarabine-Based Phase: Phase II Age: 12 to 30 Induction Chemotherapy MYELOMA Type: Biomarker/Laboratory analysis, Trial IDs: 2014-0396, NCI-2015- Phase: Phase II Busulfan, Melphalan, and Supportive care 00967, NCI-2010-01164, NCI-2012- Type: Treatment Bortezomib Before First-Line Stem Age: Over 18 01650, NCT02419469 Age: 18 to 60 continued on page 16 Trial IDs: 2014-0358, NCI-2015- Bendamustine Hydrochloride, 00849, NCT02441803 Obinutuzumab, and Dexamethasone in Treating Older Patients with Study of Efficacy and Safety of Diffuse Large B-cell Lymphoma CTL019 in Adult DLBCL Patients Phase: Phase II Phase: Phase II To Reach OT: Type: Biomarker/Laboratory analysis, Type: Treatment Treatment Age: 18 and over n Editorial, Permissions, or n Classified Advertising: Age: 70 and over Trial IDs: CCTL019C2201, NCI- Publishing Matters: Joe Anzuena National Account Trial IDs: IRB14-1120, NCI-2015- 2015-01461, 2014-003060-20, Oncology Times Manager Wolters Kluwer Health 00355, NCT02420210 NCT02445248 333 Seventh Ave. 19th Fl. Two Commerce Square New York, NY 10001 2001 Market Street Philadelphia, Pembrolizumab in Treating Patients [email protected] PA 19103 215 521-8532 with Relapsed or Refractory Chronic LUNG CANCER fax 215 701-2410 Lymphocytic Leukemia or Other Erlotinib Hydrochloride and Hsp90 n Joe.Anzuena@ wolterskluwer.com Low-Grade B-Cell Non-Hodgkin Inhibitor AT13387 in Treating Advertising Sales:
Load more

Recommended publications
  • Duvelisib Eliminates CLL B Cells, Impairs CLL- Supporting Cells, and Overcomes Ibrutinib Resistance in Preclinical Models
    Duvelisib Eliminates CLL B Cells, Impairs CLL- Supporting Cells, and Overcomes Ibrutinib Resistance in Preclinical Models Shih-Shih Chen ( [email protected] ) Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Jacqueline Barrientos Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Gerardo Ferrer Josep Carreras Leukaemia Research Institute (IJC) https://orcid.org/0000-0002-4084-6815 Priyadarshini Ravichandran Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Michael Ibrahim Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Yasmine Kieso Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Jeff Kutok Innity Pharmaceuticals Marisa Peluso Innity Pharmaceuticals, Inc Sujata Sharma Innity Pharmaceuticals, Inc David Weaver Institute of Health Sciences, Anhui University Jonathan Pachter Verastem Inc. Kanti Rai The Karches Center for Oncology Research. The Feinstein Institutes for Medical Research. Nicholas Chiorazzi Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Article Keywords: chronic lymphocytic leukemia, cancer therapy, Bruton’s Tyrosine Kinase (BTKi), phosphoinositide 3-kinase (PI3Ki) Page 1/23 Posted Date: July 21st, 2021 DOI: https://doi.org/10.21203/rs.3.rs-701669/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 2/23 Abstract Inhibitors of Bruton’s Tyrosine Kinase (BTKi) and phosphoinositide 3-kinase (PI3Ki) have signicantly improved therapy of chronic lymphocytic leukemia (CLL). However, the emergence of resistance to BTKi has introduced an unmet therapeutic need. Here we demonstrate in vitro and in vivo the essential roles of PI3K-δ for CLL B-cell survival and migration and of PI3K-γ in T-cell migration and macrophage polarization; and more ecacious inhibition in CLL-cell burden by dual inhibition of PI3K-δ,γ.
    [Show full text]
  • Minutes of the CHMP Meeting 14-17 September 2020
    13 January 2021 EMA/CHMP/625456/2020 Corr.1 Human Medicines Division Committee for medicinal products for human use (CHMP) Minutes for the meeting on 14-17 September 2020 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes Disclaimers Some of the information contained in these minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, these minutes are a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 1 Addition of the list of participants Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020.
    [Show full text]
  • Resistance to Immune Checkpoint Blockade in Uterine Leiomyosarcoma: What Can We Learn from Other Cancer Types?
    cancers Review Resistance to Immune Checkpoint Blockade in Uterine Leiomyosarcoma: What Can We Learn from Other Cancer Types? Wout De Wispelaere 1 , Daniela Annibali 1,2 , Sandra Tuyaerts 1,3 , Diether Lambrechts 4,5 and Frédéric Amant 1,6,7,* 1 Department of Oncology, KU Leuven (University of Leuven) and Leuven Cancer Institute (LKI), 3000 Leuven, Belgium; [email protected] (W.D.W.); [email protected] (D.A.); [email protected] (S.T.) 2 Division of Oncogenomics, Antoni Van Leeuwenhoek—Netherlands Cancer Institute (AvL-NKI), 1066 CX Amsterdam, The Netherlands 3 Laboratory of Medical and Molecular Oncology (LMMO), Department of Medical Oncology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), 1090 Brussels, Belgium 4 Laboratory for Translational Genetics, Department of Human Genetics, KU Leuven (University of Leuven), 3000 Leuven, Belgium; [email protected] 5 VIB Center for Cancer Biology, Flemish Institute for Biotechnology (VIB), 3000 Leuven, Belgium 6 Centre for Gynecologic Oncology Amsterdam (CGOA), Antoni Van Leeuwenhoek—Netherlands Cancer Institute, University Medical Center (UMC), 1066 CX Amsterdam, The Netherlands 7 Department of Obstetrics and Gynecology, University Hospitals Leuven (UZ Leuven), 3000 Leuven, Belgium * Correspondence: [email protected] Simple Summary: Immune checkpoint blockade (ICB) has emerged as a very promising therapeutic option for patients, demonstrating unprecedented, durable responses in several difficult-to-treat Citation: De Wispelaere, W.; cancers. Despite research indicating a strong potential for ICB in uterine leiomyosarcomas (uLMSs), a Annibali, D.; Tuyaerts, S.; Lambrechts, clinical trial assessing response to ICB monotherapy in uLMSs showed no clinical benefit. Resistance D.; Amant, F. Resistance to Immune to ICB has been studied extensively in a variety of tumor types, but the resistance mechanisms Checkpoint Blockade in Uterine explaining the lack of response to ICB in uLMSs remain largely unexplored.
    [Show full text]
  • Duvelisib for Relapsed Chronic Lymphocytic Leukaemia – Second and Subsequent Line
    Horizon Scanning Research April 2016 & Intelligence Centre Duvelisib for relapsed chronic lymphocytic leukaemia – second and subsequent line LAY SUMMARY Chronic lymphocytic leukaemia is a type of cancer which usually develops very slowly. In people with chronic lymphocytic leukaemia, the body makes too many white blood cells called lymphocytes. These This briefing is based on lymphocytes are abnormal and do not work properly so build up in the information lymph nodes (glands), spleen, bone marrow and blood. Many patients available at the time who have chronic lymphocytic leukaemia are diagnosed when having of research and a a routine blood test and if well, usually do not need to start treatment limited literature straight away. However, if the disease starts to cause symptoms, search. It is not treatment is then required. intended to be a definitive statement Duvelisib is a new type of drug for patients with chronic lymphocytic on the safety, leukaemia given as a tablet twice a day. Some studies have efficacy or suggested duvelisib may be helpful for people whose first treatment effectiveness of the has failed and whose disease has continued to spread. More studies health technology are now aiming to show how well it works and that it is safe to use. covered and should not be used for If duvelisib is licensed for use in the UK, it could be a new treatment commercial option for patients with chronic lymphocytic leukaemia that may reduce purposes or symptoms of the disease and increase survival. commissioning without additional information. NIHR HSRIC ID: 9609 This briefing presents independent research funded by the National Institute for Health Research (NIHR).
    [Show full text]
  • Phase I/II Clinical Trial of Temsirolimus and Lenalidomide in Patients with Relapsed and Refractory Lymphomas by Ajay Major, Justin Kline, Theodore G
    Phase I/II clinical trial of temsirolimus and lenalidomide in patients with relapsed and refractory lymphomas by Ajay Major, Justin Kline, Theodore G. Karrison, Paul A.S. Fishkin, Amy S. Kimball, Adam M. Petrich, Sreenivasa Nattam, Krishna Rao, Bethany G. Sleckman, Kenneth Cohen, Koen van Besien, Aaron P. Rapoport, and Sonali M. Smith Received: April 18, 2021. Accepted: July 22, 2021. Citation: Ajay Major, Justin Kline, Theodore G. Karrison, Paul A.S. Fishkin, Amy S. Kimball, Adam M. Petrich, Sreenivasa Nattam, Krishna Rao, Bethany G. Sleckman, Kenneth Cohen, Koen van Besien, Aaron P. Rapoport and Sonali M. Smith. Phase I/II clinical trial of temsirolimus and lenalidomide in patients with relapsed and refractory lymphomas. Haematologica. 2021 Jul 29. doi: 10.3324/haematol.2021.278853. [Epub ahead of print] Publisher's Disclaimer. E-publishing ahead of print is increasingly important for the rapid dissemination of science. Haematologica is, therefore, E-publishing PDF files of an early version of manuscripts that have completed a regular peer review and have been accepted for publication. E-publishing of this PDF file has been approved by the authors. After having E-published Ahead of Print, manuscripts will then undergo technical and English editing, typesetting, proof correction and be presented for the authors' final approval; the final version of the manuscript will then appear in a regular issue of the journal. All legal disclaimers that apply to the journal also pertain to this production process. Phase I/II TEM/LEN clinical trial Phase I/II clinical trial of temsirolimus and lenalidomide in patients with relapsed and refractory lymphomas Ajay Major1; Justin Kline1; Theodore G.
    [Show full text]
  • Potential Biomarkers for Treatment Response to the BCL-2 Inhibitor Venetoclax: State of the Art and Future Directions
    cancers Review Potential Biomarkers for Treatment Response to the BCL-2 Inhibitor Venetoclax: State of the Art and Future Directions Haneen T. Salah 1 , Courtney D. DiNardo 2 , Marina Konopleva 2 and Joseph D. Khoury 3,* 1 College of Medicine, Alfaisal University, Riyadh 11533, Saudi Arabia; [email protected] 2 Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA; [email protected] (C.D.D.); [email protected] (M.K.) 3 Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA * Correspondence: [email protected] Simple Summary: Apoptosis dysergulation is vital to oncogenesis. Efforts to mitigate this cancer hallmark have been ongoing for decades, focused mostly on inhibiting BCL-2, a key anti-apoptosis effector. The approval of venetoclax, a selective BCL-2 inhibitor, for clinical use has been a turning point in the field of oncology. While resulting in impressive improvement in objective outcomes, particularly for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and acute myeloid leukemia, the use of venetoclax has exposed a variety of resistance mechanisms to BCL-2 inhibition. As the field continues to move forward, improved understanding of such mechanisms and the potential biomarkers that could be harnessed to optimize patient selection for therapies that include venetoclax and next-generation BCL-2 inhibitors are gaining increased importance. Abstract: Intrinsic apoptotic pathway dysregulation plays an essential role in all cancers, particularly hematologic malignancies. This role has led to the development of multiple therapeutic agents Citation: Salah, H.T.; DiNardo, C.D.; targeting this pathway.
    [Show full text]
  • AHRQ Healthcare Horizon Scanning System – Status Update Horizon
    AHRQ Healthcare Horizon Scanning System – Status Update Horizon Scanning Status Update: April 2015 Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. HHSA290-2010-00006-C Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 April 2015 Statement of Funding and Purpose This report incorporates data collected during implementation of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Horizon Scanning System by ECRI Institute under contract to AHRQ, Rockville, MD (Contract No. HHSA290-2010-00006-C). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. A novel intervention may not appear in this report simply because the System has not yet detected it. The list of novel interventions in the Horizon Scanning Status Update Report will change over time as new information is collected. This should not be construed as either endorsements or rejections of specific interventions. As topics are entered into the System, individual target technology reports are developed for those that appear to be closer to diffusion into practice in the United States. A representative from AHRQ served as a Contracting Officer’s Technical Representative and provided input during the implementation of the horizon scanning system. AHRQ did not directly participate in the horizon scanning, assessing the leads or topics, or provide opinions regarding potential impact of interventions.
    [Show full text]
  • Standard Oncology Criteria C16154-A
    Prior Authorization Criteria Standard Oncology Criteria Policy Number: C16154-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE DUE BEFORE 03/2016 12/2/2020 1/26/2022 HCPCS CODING TYPE OF CRITERIA LAST P&T APPROVAL/VERSION N/A RxPA Q1 2021 20210127C16154-A PRODUCTS AFFECTED: See dosage forms DRUG CLASS: Antineoplastic ROUTE OF ADMINISTRATION: Variable per drug PLACE OF SERVICE: Retail Pharmacy, Specialty Pharmacy, Buy and Bill- please refer to specialty pharmacy list by drug AVAILABLE DOSAGE FORMS: Abraxane (paclitaxel protein-bound) Cabometyx (cabozantinib) Erwinaze (asparaginase) Actimmune (interferon gamma-1b) Calquence (acalbrutinib) Erwinia (chrysantemi) Adriamycin (doxorubicin) Campath (alemtuzumab) Ethyol (amifostine) Adrucil (fluorouracil) Camptosar (irinotecan) Etopophos (etoposide phosphate) Afinitor (everolimus) Caprelsa (vandetanib) Evomela (melphalan) Alecensa (alectinib) Casodex (bicalutamide) Fareston (toremifene) Alimta (pemetrexed disodium) Cerubidine (danorubicin) Farydak (panbinostat) Aliqopa (copanlisib) Clolar (clofarabine) Faslodex (fulvestrant) Alkeran (melphalan) Cometriq (cabozantinib) Femara (letrozole) Alunbrig (brigatinib) Copiktra (duvelisib) Firmagon (degarelix) Arimidex (anastrozole) Cosmegen (dactinomycin) Floxuridine Aromasin (exemestane) Cotellic (cobimetinib) Fludara (fludarbine) Arranon (nelarabine) Cyramza (ramucirumab) Folotyn (pralatrexate) Arzerra (ofatumumab) Cytosar-U (cytarabine) Fusilev (levoleucovorin) Asparlas (calaspargase pegol-mknl Cytoxan (cyclophosphamide)
    [Show full text]
  • Highlights in Chronic Lymphocytic Leukemia from the 2019 American Society of Clinical Oncology Annual Meeting
    July 2019 Volume 17, Issue 7, Supplement 11 A SPECIAL MEETING REVIEW EDITION Highlights in Chronic Lymphocytic Leukemia From the 2019 American Society of Clinical Oncology Annual Meeting A Review of Selected Presentations From the 2019 ASCO Annual Meeting • May 31-June 4, 2019 • Chicago, Illinois Special Reporting on: • Final Analysis From RESONATE: Six-Year Follow-Up in Patients With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma on Ibrutinib • Acalabrutinib With Obinutuzumab in Treatment-Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia: Three-Year Follow-Up • Long-Term Follow-Up of Previously Untreated Patients With Chronic Lymphocytic Leukemia Treated With Ofatumumab and Chlorambucil: Final Analysis of the Phase 3 COMPLEMENT 1 Trial • TRANSCEND CLL 004: Minimal Residual Disease Negative Responses After Lisocabtagene Maraleucel (JCAR017), a CD19-Directed CAR T-Cell Product, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma • Phase 1/2 Trial of Cirmtuzumab and Ibrutinib: Planned Analysis of Phase 1 CLL Cohorts • Effect of Fixed-Duration Venetoclax Plus Obinutuzumab on Progression-Free Survival, and Rates and Duration of Minimal Residual Disease Negativity in Previously Untreated Patients With Chronic Lymphocytic Leukemia and Comorbidities • Effect of Dose Modifications on Response to Duvelisib in Patients With Relapsed/Refractory CLL/SLL in the DUO Trial • Phase 2 Study of Acalabrutinib in Ibrutinib-Intolerant Patients With Relapsed/Refractory Chronic
    [Show full text]
  • Treating Non-Hodgkin Lymphoma If You’Ve Been Diagnosed with Non-Hodgkin Lymphoma, Your Treatment Team Will Discuss Your Options with You
    cancer.org | 1.800.227.2345 Treating Non-Hodgkin Lymphoma If you’ve been diagnosed with non-Hodgkin lymphoma, your treatment team will discuss your options with you. It’s important to weigh the benefits of each treatment option against the possible risks and side effects. How is non-Hodgkin lymphoma treated? Depending on the type and stage (extent) of the lymphoma and other factors, treatment options for people with NHL might include: ● Chemotherapy for Non-Hodgkin Lymphoma ● Immunotherapy for Non-Hodgkin Lymphoma ● Targeted Drug Therapy for Non-Hodgkin Lymphoma ● Radiation Therapy for Non-Hodgkin Lymphoma ● High-Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin Lymphoma ● Surgery for Non-Hodgkin Lymphoma Common treatment approaches Treatment approaches for NHL depend on the type of cancer, how advanced it is, as well as your health and other factors. Another important part of treatment for many people is palliative or supportive care. This can help prevent or treat problems such as infections, low blood cell counts, or some symptoms caused by the lymphoma. ● Treating B-Cell Non-Hodgkin Lymphoma ● Treating T-Cell Non-Hodgkin Lymphoma ● Treating HIV-Associated Lymphoma 1 ____________________________________________________________________________________American Cancer Society cancer.org | 1.800.227.2345 ● Palliative and Supportive Care for Non-Hodgkin Lymphoma Who treats non-Hodgkin lymphoma? Based on your treatment options, you may have different types of doctors on your treatment team. These doctors could include: ● A medical oncologist or hematologist: a doctor who treats lymphoma with chemotherapy, immunotherapy, and targeted therapy. ● A radiation oncologist: a doctor who treats cancer with radiation therapy. ● A bone marrow transplant doctor: a doctor who specializes in treating cancer or other diseases with bone marrow or stem cell transplants.
    [Show full text]
  • (CHMP) Agenda for the Meeting on 14-17 September 2020
    14 September 2020 EMA/CHMP/481238/2020 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 14-17 September 2020 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 14 September 2020, 08:30 – 19:30, room 1C/ virtual meeting 15 September 2020, 08:30 – 19:30, room 1C/ virtual meeting 16 September 2020, 08:30 – 19:30, room 1C/ virtual meeting 17 September 2020, 08:30 – 18:00, room 1C/ virtual meeting Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020.
    [Show full text]
  • Duvelisib: a Phosphoinositide-3 Kinase Δ/Γ Inhibitor for Chronic Lymphocytic Leukemia
    HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Expert Opin Manuscript Author Investig Drugs Manuscript Author . Author manuscript; available in PMC 2018 May 01. Published in final edited form as: Expert Opin Investig Drugs. 2017 May ; 26(5): 625–632. doi:10.1080/13543784.2017.1312338. Duvelisib: A Phosphoinositide-3 Kinase δ/γ Inhibitor for Chronic Lymphocytic Leukemia Hima V. Vangapandu1, Nitin Jain2, and Varsha Gandhi1,* 1Department of Experimental Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, 77054 2Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX 77030 Abstract Introduction—Frontline chemotherapy is successful against chronic lymphocytic leukemia (CLL), but results in untoward toxicity. Further, prognostic factors, cytogenetic anomalies, and compensatory cellular signaling lead to therapy resistance or disease relapse. Therefore, for the past few years, development of targeted therapies is on the rise. PI3K is a major player in the B- cell receptor (BCR) signaling axis, which is critical for the survival and maintenance of B cells. Duvelisib, a PI3K δ/γ dual isoform specific inhibitor that induces apoptosis and reduces cytokine and chemokine levels in vitro, holds promise for CLL. Areas covered—Herein, we review PI3K isoforms and their inhibitors in general, and duvelisib in particular; examine literature on preclinical investigations, pharmacokinetics and clinical studies of duvelisib either as single agent or in combination, for patients with CLL and other lymphoid malignancies. Expert opinion—Duvelisib targets the PI3K δ isoform, which is necessary for cell proliferation and survival, and γ isoform, which is critical for cytokine signaling and pro-inflammatory responses from the microenvironment.
    [Show full text]