Leukemia/ Protocol List

July 2021

ALL treatment protocols Study Clinical trial name Phase/type Age

AALL1631, International Phase 3 Trial in -Positive Acute Lymphoblastic Ph+ >1 to COG ALL Testing in Combination with Two Different III AALL1631 <21 yr Cytotoxic Chemotherapy Backbones https://clinicaltrials.gov/ct2/show/NCT03007147

AALL1731, A Phase 3 Trial Investigating (IND# >365 days to <10 yr 117467, NSC# 765986) in Combination with in (B-ALL wo/DS) Patients with Newly Diagnosed Standard Risk or Down COG REQ for B-ALL Syndrome B Lymphoblastic Leukemia (B-ALL) and the III >365 days to <31 yr AALL1731 Treatment of Patients with Localized (B-ALL w/DS and B- B-Lymphoblastic Lymphoma (B-LLy) LLy w or wo DS)

https://clinicaltrials.gov/ct2/show/NCT03914625

AALL1732, A Phase 3 Randomized Trial of (IND#:133494, NSC#: 772518) for Newly COG Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction AALL1732 REQ for B-ALL, MPAL Therapy for High-Risk B-ALL, Mixed Phenotype Acute III >365 days to <25 yr Leukemia, and Disseminated B-LLy

https://clinicaltrials.gov/ct2/show/NCT03959085

Phase 1b Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute 20140106 Ib/II <18 yr (formerly ONYX CFZ008) Lymphoblastic Leukemia https://clinicaltrials.gov/ct2/show/NCT02303821

INCB 18424-269: A Phase 2 Study of JAK1/JAK2 Inhibitor with Chemotherapy in Children with De Novo High- >1 to COG Risk CRLF2-rearranged and/or JAK Pathway-mutant Acute II <21 yr AALL1521 [Incyte] Lymphoblastic Leukemia https://clinicaltrials.gov/ct2/show/NCT02723994

AALL1621, A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic >1 to COG II AALL1621 Leukemia (B-ALL) <22 yr https://clinicaltrials.gov/ct2/show/NCT02981628

A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) who are Minimal Residual Novartis Disease (MRD) Positive at the End of Consolidation (EOC) II 1 to 25 yr Cassiopeia (AALL1721) Therapy https://clinicaltrials.gov/ct2/show/NCT03876769

ADVL1823, (LOXO-101, NSC# 788607, IND# COG 141824) for Previously Untreated TRK Fusion Pediatric Solid II <30 yr ADVL1823 Tumors and TRK Fusion Relapsed Pediatric Acute https://clinicaltrials.gov/ct2/show/NCT03834961

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of in Pediatric and Young Adult Subjects ≥1 and ≤30 Years of Age With Relapsed/ >1 to JNJ Daratumumab II Refractory Precursor B-cell or T-cell Acute Lymphoblastic <30 yr Leukemia or Lymphoblastic Lymphoma https://clinicaltrials.gov/ct2/show/NCT03384654

Protocol CCTL019B2202: A Phase II, Single Arm, Multicenter Novartis CART Trial to Determine the Efficacy and Safety of CTL019 in ELIANA Pediatric Patients with Relapsed and Refractory B-cell Acute II >3 to <21 yr Lymphoblastic Leukemia https://clinicaltrials.gov/ct2/show/NCT02435849

Protocol No.CCTL019A2205B: Long Term Follow-up of any age (received Patients Exposed to Lentiviral-Based CD19 directed CART NA anti-CD19 directed Novartis CART FU Cell Therapy CART therapy) https://clinicaltrials.gov/ct2/show/NCT02445222

A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination with UK ALL R3 Induction TACL >1 to Chemotherapy for Children, Adolescents, and Young Adults Pilot <21 yr 2012-002 with Relapse of Acute Lymphoblastic Leukemia https://clinicaltrials.gov/ct2/show/NCT02879643

A TACL Phase 1/2 Study of PO Ixazomib in Combination with Chemotherapy for Childhood Relapsed or Refractory Acute TACL 2017-002 Lymphoblastic Leukemia and Lymphoblastic I/II <21 yr Lymphoma https://clinicaltrials.gov/ct2/show/NCT03817320

ENCERT: A Phase 1 Trial using in combination with Nelarabine, Cyclophosphamide and Etoposide in >1 to AflacLL1602 I ENCERT Relapsed T cell Lymphoblastic Leukemia/Lymphoma <30 yr https://clinicaltrials.gov/ct2/show/NCT03328104

Phase I Trial of in Combination with Everolimus and DFCI 18-328 Dexamethasone in Children and Young Adults with Relapsed I ˃12 mo to ≤30 yr Acute Lymphoblastic Leukemia

ALL biology, supportive treatment and non-therapeutic protocols Study Clinical trial name Phase/type Age

Aflac Precision Medicine Program (APMP) Study Non- <30 yr AflacPM1702 therapeutic

Non- Childhood Cancer Predisposition Study (CCPS) <21 yr primary subj CCPS therapeutic https://clinicaltrials.gov/ct2/show/NCT04511806

NCI COVID-19 in Cancer Patients Study (NCCAPS): Non- A Longitudinal Natural History Study Any age NCICOVID therapeutic https://clinicaltrials.gov/ct2/show/NCT04387656

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APEC14B1: The Project:Everychild Protocol: A Registry, Non- COG Eligibility Screening, Biology and Outcome Study <25 yr therapeutic APEC14B1 https://clinicaltrials.gov/ct2/show/NCT02402244

Key Adverse Events after Childhood Cancer (cardiac, stroke, Non- COG secondary malig)/closed to AVN patients as of 11-26-08 <21 yr at dx ALTE03N1 therapeutic https://clinicaltrials.gov/ct2/show/NCT00082745

Umbrella Long-Term Follow-Up Protocol Non- COG All ages ALTE05N1 https://clinicaltrials.gov/ct2/show/NCT00736749 therapeutic

ALTE07C1, Neuropsychological, Social, Emotional and Non- COG Behavioral Outcomes in Children with Cancer 3 to <22 yr therapeutic ALTE07C1 https://clinicaltrials.gov/ct2/show/NCT00772200

ALTE1631, A Randomized Web-based Physical Activity COG Intervention among Children and Adolescents with Acute >8 to NA ALTE1631 Lymphoblastic Leukemia <16 yr https://clinicaltrials.gov/ct2/show/NCT03223753

Development and Pilot of a Telehealth Home-based Transition Non- Telehealth Home-based <29 yr Transition Intervention for Pediatric and Young Adults with Cancer therapeutic

AML treatment protocols Study Clinical trial name Phase/type Age

A Single Arm, Open-label, Phase 4 Study Evaluating QT Interval, Pharmacokinetics, and Safety of (Mylotarg) as a Single-agent Regimen in Patients IV >12 yr Pfizer B1761031 Mylotarg with Relapsed or Refractory CD33-positive Acute Myeloid Leukemia https://clinicaltrials.gov/ct2/show/NCT03727750

Risk-stratified Therapy for Acute Myeloid Leukemia in Down COG Syndrome III >90 days to <4 yr AAML1531 https://clinicaltrials.gov/ct2/show/NCT02521493

AAML1831, A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the AAML1831REQ Addition of the FLT3 Inhibitor for Patients with FLT3 III <22 yr Mutations https://clinicaltrials.gov/ct2/show/NCT04293562

ADVL1521: A Phase 2 Study of the MEK Inhibitor (IND #119346, NSC# 763093) in Children with Relapsed or >2 to COG II ADVL1521 Refractory Juvenile Myelomonocytic Leukemia <22 yr https://clinicaltrials.gov/ct2/show/NCT03190915

ADVL1823, Larotrectinib (LOXO-101, NSC# 788607, IND# COG 141824) for Previously Untreated TRK Fusion Pediatric Solid II <30 yr ADVL1823 Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias https://clinicaltrials.gov/ct2/show/NCT03834961

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A Phase 1/2, Multi-center, Dose-escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmaconynamics, and Efficacy of Administered in Combination with Re- AC220-A-U202 induction Chemotherapy, and as a Single-agent Continuation I/II >1 mo to <21 yr (ADVL1822) Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) with FLT3-ITD Mutations https://clinicaltrials.gov/ct2/show/NCT03793478

TACL2016-002: A TACL Phase 1/2 Study of in Combination with 5-azacytidine in pediatric patients with >1 to I/II TACL 2016-002 relapsed/refractory acute myeloid leukemia (BMS reference <30 yr CA209-9JY)

Stopping Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid <18 yr at diag; Pilot AAML18P1 Leukemia - Chronic Phase (CML-CP) <25 yr at enroll https://clinicaltrials.gov/ct2/show/NCT03817398

PEPN1812: A Phase 1 Trial of the CD123 X CD3 Dual Affinity Re-targeting Antibody Flotetuzumab (NSC#808294, PEPN1812 IND#145986) in Children, Adolescents, and Young Adults with I <21 yr Relapsed or Refractory Acute Myeloid Leukemia https://clinicaltrials.gov/ct2/show/NCT04158739

AML biology, supportive treatment and non-therapeutic protocols Study Clinical trial name Phase/type Age

Non- Aflac Precision Medicine Program (APMP) Study <30 yr AflacPM1702 therapeutic

Non- Childhood Cancer Predisposition Study (CCPS) <21 yr primary subj CCPS therapeutic https://clinicaltrials.gov/ct2/show/NCT04511806

NCI COVID-19 in Cancer Patients Study (NCCAPS): Non- A Longitudinal Natural History Study Any age NCICOVID therapeutic https://clinicaltrials.gov/ct2/show/NCT04387656

Umbrella Long-Term Follow-Up Protocol Non- COG All ages ALTE05N1 https://clinicaltrials.gov/ct2/show/NCT00736749 therapeutic

Home of Away from Home: Comparing Clinical Outcomes Relevant to the Care of Pediatric Acute Myeloid Leukemia Non- during Periods of Neutropenia [Aim 3 closed to accrual; Aim 1 Any age Arnold PCORI therapeutic open] https://clinicaltrials.gov/ct2/show/NCT02774850

Development and Pilot of a Telehealth Home-based Transition Non- Telehealth Home-based <29 yr Transition Intervention for Pediatric and Young Adults with Cancer therapeutic

NHL treatment protocols Study Clinical trial name Phase/type Age

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>365 days to <10 yr AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# (B-ALL wo/DS) 117467, NSC# 765986) in Combination with Chemotherapy in

Patients with Newly Diagnosed Standard Risk or Down COG III >365 days to <31 yr REQ for B-ALL Syndrome B Lymphoblastic Leukemia (B-ALL) and the AALL1731 (B-ALL w/DS and B- Treatment of Patients with Localized B-Lymphoblastic LLy w or wo DS) Lymphoma (B-LLy )

https://clinicaltrials.gov/ct2/show/NCT03914625

AALL1732, A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly COG Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction REQ for B-ALL, MPAL III >365 days to <25 yr AALL1732 Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy https://clinicaltrials.gov/ct2/show/NCT03959085

A Randomized Phase II Trial of (SGN35, NSC#749710), or (NSC#749005, commercially labeled) in Combination with Chemotherapy for Newly COG Diagnosed Patients with Anaplastic Large Cell Lymphoma II <22 yr ANHL12P1 (ALCL) IND #117117 https://clinicaltrials.gov/ct2/show/NCT01979536

APEC1621A: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 COG >12 mo to REQ (Larotrectinib) in Patients with Tumors Harboring Actionable II <21 yr APEC1621A NTRK Fusions https://clinicaltrials.gov/ct2/show/NCT03213704

APEC1621B: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of COG JNJ-42756493 (Erdafitinib) in Patients with Relapsed Pediatric >12 mo to REQ II APEC1621B Solid Tumors Harboring FGFR1/2/3/4 Alterations <21 yr https://clinicaltrials.gov/ct2/show/NCT03210714

APEC1621D NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 Subprotocol of LY3023414 in COG II >12 mo to <21 yr APEC1621DREQ Patients with Solid Tumors https://clinicaltrials.gov/ct2/show/NCT03213678 APEC1621F NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 Subprotocol of Ensartinib in COG Patients with Tumors Harboring ALK or ROS1 Genomic REQ II >12 mo to <21 yr APEC1621F Alterations https://clinicaltrials.gov/ct2/show/NCT03213652

APEC1621G NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 Subprotocol of in COG REQ Patients with Tumors Harboring Actionable BRAF V600 II >12 mo to <21 yr APEC1621G Mutations https://clinicaltrials.gov/ct2/show/NCT03220035

APEC1621H NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)—Phase 2 Subprotocol of Olaparib in COG REQ Patients with Tumors Harboring Defects in DNA Damage II >12 mo to <21 yr APEC1621H Repair Genes https://clinicaltrials.gov/ct2/show/NCT03233204

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APEC1621I NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)—Phase 2 Subprotocol of in COG REQ Patients with Tumors Harboring Activating Alterations in Cell II >12 mo to <21 yr APEC1621I Cycle Genes https://clinicaltrials.gov/ct2/show/NCT03526250 APEC1621J NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)—Phase 2 Subprotocol of BVD-523FB COG REQ (Ulixertinib) in Patients with Tumors Harboring Activating II >12 mo to <21 yr APEC1621J MAPK Pathway Mutations https://clinicaltrials.gov/ct2/show/NCT03698994

A Non-randomized, Open-label, Multi-center, Phase I/II Study of PI3K Inhibitor Copanlisib in Pediatric Patients with COG I/II >6 mo to <21 yr ADVL1721 Relapsed/ Refractory Solid Tumors or Lymphoma https://clinicaltrials.gov/ct2/show/NCT03458728

ADVL1414, A Phase 1 Study of Selinexor (KPT-330, IND# COG 125052), A Selective XPO1 Inhibitor, in Recurrent and I >12 mo to <21 yr ADVL1414 Refractory Pediatric Solid Tumors, including CNS Tumors https://clinicaltrials.gov/ct2/show/NCT02323880

A Phase 1 Study of the Safety and Pharmacokinetics of in Pediatric and Young Adult Patients with AbbVie I <25 yr M13-833 Relapsed or Refractory Malignancies https://clinicaltrials.gov/ct2/show/NCT03236857

NHL biology, supportive treatment and non-therapeutic protocols Study Clinical trial name Phase/type Age

Non- Aflac Precision Medicine Program (APMP) Study <30 yr AflacPM1702 therapeutic

Childhood Cancer Predisposition Study (CCPS) Non- <21 yr primary subj CCPS https://clinicaltrials.gov/ct2/show/NCT04511806 therapeutic

NCI COVID-19 in Cancer Patients Study (NCCAPS): Non- A Longitudinal Natural History Study Any age NCICOVID therapeutic https://clinicaltrials.gov/ct2/show/NCT04387656 Key Adverse Events after Childhood Cancer (cardiac, stroke, Non- COG secondary malig)/closed to AVN patients as of 11-26-08 <21 yr at dx therapeutic ALTE03N1 https://clinicaltrials.gov/ct2/show/NCT00082745

Umbrella Long-Term Follow-Up Protocol Non- COG All ages ALTE05N1 https://clinicaltrials.gov/ct2/show/NCT00736749 therapeutic

Development and Pilot of a Telehealth Home-based Transition Non- Telehealth Home-based <29 yr Transition Intervention for Pediatric and Young Adults with Cancer therapeutic

Hodgkin disease treatment protocols Study Clinical trial name Phase/type Age

A Phase III, Randomized Study of Nivolumab (Opdivo) plus SWOG AVD or Brentuximab Vedotin (Adcetris) plus AVD in Patients S1826 (Age >/= 12 years) with Newly Diagnosed Advanced Stage III >12 yr Classical Hodgkin Lymphoma https://clinicaltrials.gov/ct2/show/NCT03907488

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Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, COG Adolescents, and Young Adults with Relapsed/refractory (R/R) AHOD1721 CD30 + Classic Hodgkin lymphoma (cHL) after Failure of First- II 5 to 30 yr CA209744 line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants with a Suboptimal Response https://clinicaltrials.gov/ct2/show/NCT02927769

An Open-label, Uncontrolled, Multicenter Phase II Trial of MK- 3475 () in Children and Young Adults with COG Newly Diagnosed Classical Hodgkin Lymphoma wi th >3 to II AHOD1822 (MK3475-667) Inadequate (Slow Early) Response to Frontline Chemotherapy <25 yr (KEYNOTE 667) https://clinicaltrials.gov/ct2/show/NCT03407144

A Non-randomized, Open-label, Multi-center, Phase I/II Study COG of PI3K Inhibitor Copanlisib in Pediatric Patients with I/II >6 mo to <21 yr ADVL1721 Relapsed/ Refractory Solid Tumors or Lymphoma https://clinicaltrials.gov/ct2/show/NCT03458728

ADVL1414, A Phase 1 Study of Selinexor (KPT-330, IND# 125052), A Selective XPO1 Inhibitor, in Recurrent and COG I >12 mo to <21 yr ADVL1414 Refractory Pediatric Solid Tumors, including CNS Tumors https://clinicaltrials.gov/ct2/show/NCT02323880

A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of , Nivolumab E4412 and Brentuximab Vedotin in Patients with Relapsed/Refractory II ≥12 yr Hodgkin Lymphoma https://clinicaltrials.gov/ct2/show/NCT01896999

Hodgkin disease biology, supportive treatment and non-therapeutic protocols Study Clinical trial name Phase/type Age

Non- Aflac Precision Medicine Program (APMP) Study <30 yr AflacPM1702 therapeutic

Childhood Cancer Predisposition Study (CCPS) Non- <21 yr primary subj CCPS https://clinicaltrials.gov/ct2/show/NCT04511806 therapeutic

NCI COVID-19 in Cancer Patients Study (NCCAPS): Non- A Longitudinal Natural History Study Any age NCICOVID therapeutic https://clinicaltrials.gov/ct2/show/NCT04387656

Umbrella Long-Term Follow-Up Protocol Non- COG All ages ALTE05N1 https://clinicaltrials.gov/ct2/show/NCT00736749 therapeutic

Development and Pilot of a Telehealth Home-based Transition Non- Telehealth Home-based <29 yr Transition Intervention for Pediatric and Young Adults with Cancer therapeutic

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