Malignant Hematology

Myeloproliferative Neoplasm PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Fleischman Cody Slicker UCI 19-31: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Selective inhibitor of JAK1, PMF diagnosis, Symptomatic, defined as a MFSAF TSS of ≥ 10 units assessed by a Open to accural Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic JACK2 single MFSAF v4.0 assessment at screening visit, anemic, Previously treated, with Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) an approved JAK inhibitor for PMF or Post-PV/ET MF for ≥ 90 days, or ≥ 28 days if Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were JAK inhibito Previously Treated with JAK Inhibitor Therapy

Myelodysplastic Syndrome PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Jeyakumar Blake UCI 16-13: A Phase I Dose Escalation with Two Disease Specific Expansions, MYC inhibitor High-risk myelodysplasia (MDS): Patients must have a score of > 4.5 on the Revised Open to accural Johnson Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study International Prognostic Scoring System (IPSS-R) for whom all standard therapy of APTO-253 in Patients with Relapsed or Refractory Hematologic options have failed or which are considered inappropriate Malignancies O'Brien Veronica De UCI 17-19: A Phase I, Open-Label, Multicentre Study to Assess the Safety, MCL-1 inhibitor Must have received at least 2 prior lines of therapy Open to accrual Santiago Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Recurrence of disease after response to prior line(s) of therapy Or progressive Doses of AZD5991 in Subjects with Relapsed or Refractory Haematologic disease after completion of the treatment regimen preceding entry into the study Malignancies There are no treatment options available known to provide clinical benefit

Jeyakumar Veronica De UCI 20-48: A Randomized, Double-blind, Multicenter Study Comparing Anti-CD47 monoclonal Confirmed intermediate, high, or very high risk MDS that is previously untreated or Open to accrual Santiago Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in antibody relapsed, refractory or intolerant to conventional therapy Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome WBC count <20k

Jeyakumar Veronica De ETCTN-10264: The PRIME Trial: PARP Inhibition in IDH Mutant Effectiveness PARP Inhibitor IDH1/2 mutation with R/R AML Open to accrual Santiago Trial. A Phase II Study of Olaparib in Isocitrate Dehydrogenase (IDH) Mutant Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome

Jeyakumar An To UCI 19-79: A Phase Ib Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Anti-CD47 monoclonal Confirmed intermediate, high, or very high risk MDS that is previously untreated or Open to accrual Combination with Azacitidine in Patients with Hematological Malignancies antibody relapsed, refractory or intolerant to conventional therapy WBC count <20k

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Newly Diagnosed Acute Myeloid Leukemia PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Jeyakumar An To ETCTN-10300: Blockade of PD-1 Added to Standard Therapy to Target PDL-1 inhibitor + SOC Must have untreated AML and be a candidate for intensive chemo therapy Pending activation Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-chemo 1): A Randomized Phase II Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid Leukemia Jeyakumar An To UCI 16-100: A Phase II/III Multicenter, Open-label, Three-Arm, Two-Stage FLT3 inhibitor Subjects with untreated AML and is positive for FLT3 mutation (ITD or TKD Closed to Accrual Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus [D835/I836] mutation) in bone marrow or whole blood as determined by central Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute laboratory. Myeloid Leukemia with FLT3 Mutation Must be ineligible for intensive induction chemotherapy QTc interval < or = 450 msec using the Fridericia correction Must NOT require treatment with concomitant drugs that are strong inducers of CYP3A Jeyakumar An To UCI 18-76: Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated FLT3 inhibitor Subjects with untreated FLT3 mutated Non M3 AML (FLT3-TKD or FLT3-ITD Open to accrual Acute Myeloid Leukemia (AML) allowed). Patients may not have hypomethylating agent within 21 days.

Brem An To UCI 18-128 A Phase I/IB Study of Pitavastatin in Combination with Venetoclax HMA+BCL2 Newly diagnosed AML not eligible for intensive induction. Must reach stable dose of Open to accrual for Chronic Lymphocytic Leukemia (CLL) and Acute Myeloid Leukemia (AML) inhibitor+Statin venetoclax prior to starting Pitavastatin

Jeyakumar An To UCI 19-138: A Phase Ib/II Study of IMGN632 as Monotherapy or Combination CD123 antibody Must have CD123+ AML Open to accrual with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

Jeyakumar An To UCI 18-105: Phase II study of the combination of CPX-351 and Glasdegib in Combination of hedgehog Previously untreated therapy-related AML or AML with myelodysplastic related Open to accrual previously untreated patients with Acute Myelogenous Leukemia with MDS signaling pathway inhibitor changes as described by WHO related changes or therapy-related Acute myeloid leukemia and lipsomal formulation of a. AML arising in MDS (including CMML) or MDS/MPN syndrome cytotoxic chemotherapy b. AML with MDS-related cytogenetic abnormalities (metaphase FISH allowable as Daunorubicin and surrogate for cytogenetics) Cytarabine c. AML with multilineage dysplasia involving the presence of 50% or more dysplastic cells in at least two cell lines and in the absence of mutation in NPM1 or CEBPA (as per WHO 2016)

Jeyakumar An To UCI 20-30 A Randomized, Open-Label, Controlled, Phase 2 Study of nedd8 activating enzyme Must be unfit for intensive chemo. Open to accrual Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine with bcl-2 inhibitor and in Adults with Newly Diagnosed Acute Myeloid Leukemia who are Unfit for hypomethylating agent Intensive Chemotherapy Jeyakumar An To UCI 19-79: A Phase Ib Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Anti-CD47 monoclonal Previously untreated patients with histological confirmation of AML who are ineligible Open to accrual Combination with Azacitidine in Patients with Hematological Malignancies antibody for treatment with a standard cytarabine and anthracycline induction regimen WBC < 20k

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Relapsed/Refractory Acute Myeloid Leukemia PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Jeyakumar An To UCI 20-51: A Phase 1, Multicenter, Open-Label, Dose-Escalation and LILRB4 antibody AML with myelomonocytic or monoblastic/monocytic differentiation according to the Open to accrual Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity World Health Organization 2016 criteria Study of Intravenously Administered IO-202 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML) Patients

Jeyakumar Blake UCI 16-13: A Phase I Dose Escalation with Two Disease Specific Expansions, MYC inhibitor Acute myelogenous leukemia: Patients with any subtype of refractory or relapsed Open to accural Johnson Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study AML are eligible as are patients with AML who have relapsed after a stem cell of APTO-253 in Patients with Relapsed or Refractory Hematologic transplant unless they have active graft versus host disease (GVHD) requiring Malignancies systemic immunosuppresant

Jeyakumar Blake UCI 17-02: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of BET inhibitor Relapsed subjects should not be in the first relapse period following a remission Open to accrual Johnson ABBV-744 in Subjects with Metastatic Castrate Resistant Prostate Cancer period of > 12 months, nor be eligible for standard therapies (CRPC) and Relapsed/Refractory Acute Myeloid Leukemia Refractory subjects should have failed to achieve a CR after ≥ 2 cycles of induction chemotherapy or at least 4 cycles of a hypomethylating agent

O'Brien Veronica De UCI 17-19: A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess MCL-1 inhibitor, MCL-1 Must have received at least 2 prior lines of therapy Open to accrual Santiago the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of inhibitor + BCL-2 inhibitor Recurrence of disease after response to prior line(s) of therapy Or progressive Ascending Doses of AZD5991 Monotherapy and in Combination with disease after completion of the treatment regimen preceding entry into the study Venetoclax in Subjects with Relapse There are no treatment options available known to provide clinical benefit

Jeyakumar An To UCI 18-38: A Phase 1b Trial with Dose Expansion CPX-351 (Vyxeos) Plus Combination of anti-CD33 Bone marrow blasts >=5% that develops after remission, no restriction on prior Open to accrual Gemtuzumab Ozogamicin (Mylotarg) for Relapsed Acute Myelogenous monoclonal antibody with number of relapses or regimens, including relapse after HSCT Leukemia lipsomal formulation of At least a 3 month duration of remission prior to relapse cytoxic chemotherapy Continued use of FLT3, IDH1, IDH2 targeted therapies are excluded Daunorubicin and Jeyakumar An To UCI 18-77: A Phase III Multicenter Open-Label Randomized Trial to Evaluate Metabolic No marked baseline of prolongation of QT/QTc interval (>450 ms for males, >470 for Open to accrual Trial to Evaluate Efficacy and Safety of CPI-613 in Combination with High Dose pathway/Dehydrogenase females) Cytarabine and Mitoxantrone (CHAM) compared to High Dose Cytarabine with inhibitor No prior cytotoxic chemotherapy for relapsed or refractory AML Mitoxantrone (HAM) in Older No prior allogenic bone marrow transplantation Jeyakumar An To UCI 19-51: CPX-351 plus Enasidenib for Relapsed Acute Myelogenous Combination of IDH2 R/R AML characterized by IDH2 mutation Pending activation Leukemia Characterized by the IDH2 Mutation inhibitor with lipsomal -3 months since previous cytotoxic therapy formulation of cytoxic -Must have been in CR/Cri for at least 3 months chemotherapy Jeyakumar An To UCI 19-93: Phase III Randomized Trial of DFP-10917 vs. Non-Intensive Nucleoside Analog R/R AML to at least 2-3 regimens Open to accrual Reinduction (LoDAC, Azacitidine, Decitabine) or Intensive Reinduction (High Two week wash out for previous cytotoxic agents and Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Previous HSCT allowed Leukemia Patients in Second or Third Salvage

Jeyakumar Veronica De S ETCTN-10264: The PRIME Trial: PARP Inhibition in IDH Mutant Effectiveness PARP Inhibitor IDH1/2 mutation with R/R AML Open to accrual Trial. A Phase II Study of Olaparib in Isocitrate Dehydrogenase (IDH) Mutant Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome

Jeyakumar An To UCI 19-79: A Phase Ib Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Anti-CD47 monoclonal R/R AML or confirmed intermediate, high, or very high risk MDS that is relapsed, Open to accrual Combination with Azacitidine in Patients with Hematological Malignancies antibody refractory or intolerant to conventional therapy WBC count <20k

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Newly Diagnosed Acute Lymphoblastic Leukemia PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Jeyakumar Blake S1318: A Phase II Study of Blinatumomab (NSC-765986) and POMP TKI inhibitor Newly Diagnosed, 65 years and older, Ph-positive Patients who are both dasatinib Open to accural Johnson (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients =/< 65 and other 2nd/3rd generation TKI-naive. (Cohort 2) Years of Age with Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of

Jeyakumar Blake A041501: A Phase III Trial to Evaluate the Efficacy of the Addition of Conjugated Anti-CD22 Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia Open to accrual Johnson Inotuzumab Ozogamicin to Frontline Therapy in Young Adults with Newly Monoclonal Antibody Submission of bone marrow aspirate for LDA assay is mandatory prior to registration Diagnosed Precursor B-Cell ALL for stratification NO prior therapy for ALL except for limited treatment NO BCR-ABL fusion transcript determined by FISH or RT-PCR or t(9;22)(q34;q11) by cytogenetics Age ≥ 18 years and < 40 years

Relapsed/Refractory Acute Lymphoblastic Leukemia

PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Jeyakumar Cody Slicker UCI 20-34: A Phase IV, Multi-Center Open-Label Feasibility Study to Evaluate bispecific T-cell engager MRD positive disease in a complete remission. Pending activation Outpatient Blinatumomab Administration in Adult Subjects with Minimal (BiTE) which binds to Residual Disease (MRD) of B-Precursor Acute Lymphoblastic Leukemia (ALL) CD19 expressed on B-cells in Complete Hematologic Remission and CD3 expressed on T- cells and PD-1 inhibitor

Jeyakumar Blake UCI 14-95: A Phase I/II Study of the Blinatumomab in Combination with the PD- bispecific T-cell engager R/R CD19-positive B-lineage acute lymphoblastic leukemia having received at least Open to accrual Johnson 1 Inhibitor Pembrolizumab (MK-3475) for the Treatment of Adults with (BiTE) which binds to 1 prior line of therapy Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia CD19 expressed on B-cells Philadelphia chromosome/BCR-ABL1-positive B-lineage ALL must have failed at and CD3 expressed on T- least 1 2nd or 3rd generation TKI or be intolerant to TKIs cells and Greater than 50% lymphoblasts on screening bone marrow aspirate or biopsy PD-1 inhibitor

Jeyakumar Blake S1318: A Phase II Study of Blinatumomab (NSC-765986) and POMP TKI inhibitor Relapsed/Refractory Ph-positive Patients who are both dasatinib and other 2nd/3rd Open to accural Johnson (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients =/< 65 generation TKI-naive. (Cohort 2) Years of Age with Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of

O'Brien Veronica De UCI 17-19: A Phase I, Open-Label, Multicentre Study to Assess the Safety, MCL-1 inhibitor Must have received at least 2 prior lines of therapy Open to accrual Santiago Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Recurrence of disease after response to prior line(s) of therapy Or progressive Doses of AZD5991 in Subjects with Relapsed or Refractory Haematologic disease after completion of the treatment regimen preceding entry into the study Malignancies Presence of superficial lymphadenopathy for the lymph node biopsy (applies only to CLL, lymphoma and ALL) There are no treatment options available known to provide clinical benefit

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Newly Diagnosed Chronic Lymphocytic Leukemia PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Brem An To UCI 18-128 A Phase I/IB Study of Pitavastatin in Combination with Venetoclax HMA+BCL2 Newly diagnosed CLL eligible for venetoclax therapy (combination with Open to accrual for Chronic Lymphocytic Leukemia (CLL) and Acute Myeloid Leukemia (AML) inhibitor+Statin(HMG-CoA obinutuzumab) as per FDA indication. Must reach stable dose of venetoclax prior to reductase inhibitor) starting Pitavastatin. O'Brien Blake A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab BTK + BCL2 + CD20 Must have newly diagnosed CLL to be eligible. Age ≥ 70 years. Pending activation Johnson Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older antibody Patients (>/= 70 years of age) With Chronic Lymphocytic Leukeumia (CLL)

O'Brien Blake ECOG-EA9161: A Randomized Phase III Study of the Addition of BCL2 inhibitor + BTK Must have newly diagnosed CLL according to the NCI/IWCLL criteria or SLL Pending activation Johnson Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib inhibitor + anti-CD20 according to the WHO criteria. Age ≥ 18 years and < 70. and Obinutuzumab in Untreated Younger Patients with monoclonal antibody Chronic Lymphocytic Leukemia (CLL) Relapsed/Refractory Chronic Lymphocytic Leukemia

PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Brem An To UCI 18-128 A Phase I/IB Study of Pitavastatin in Combination with Venetoclax HMA+BCL2 Relapsed/refractory CLL eligible for venetoclax therapy (with or without Rituxan) as Open to accrual for Chronic Lymphocytic Leukemia (CLL) and Acute Myeloid Leukemia (AML) inhibitor+Statin(HMG-CoA per FDA indication. Must reach stable dose of venetoclax prior to starting reductase inhibitor) Pitavastatin.

O'Brien Cody Slicker UCI 15-18: An Open-Label, Multi-Center Phase 1 Study to Investigate the anti-CD20 x anti-CD3 CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for Suspended Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific bispecific antibody whom no standard of care options exists, and for whom treatment with an anti-CD20 Monoclonal Antibody, in Patients with CD20+ B-Cell Malignancies Previously antibody may be appropriate Treated with CD20-Directed Antibody Patients with CLL are not required to have received prior treatment with an anti- CD20 antibody therapy, must have failed either a BTK inhibitor or PI3K inhibitor Patients with CLL must have WBC ≤200 x 109/L Multiple Myeloma

PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status O'Brien Veronica De UCI 17-19: A Phase I, Open-Label, Multicentre Study to Assess the Safety, MCL-1 inhibitor Must have received at least 2 prior lines of therapy Open to accrual Santiago Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Recurrence of disease after response to prior line(s) of therapy Or progressive Doses of AZD5991 in Subjects with Relapsed or Refractory Haematologic disease after completion of the treatment regimen preceding entry into the study Malignancies There are no treatment options available known to provide clinical benefit

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Follicular Lymphoma PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status O'Brien Veronica De UCI 15-18: An Open-Label, Multi-Center Phase 1 Study to Investigate the anti-CD20 x anti-CD3 Have documented CD20+ B-cell malignancy, with active disease not responsive to Suspended Santiago Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific bispecific antibody prior therapy, for whom no standard of care options exists, and for whom treatment Monoclonal Antibody, in Patients with CD20+ B-Cell Malignancies Previously with an anti-CD20 antibody may be appropriate Treated with CD20-Directed Antibody Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy Measurable disease

Brem Veronica De UCI 17-47: A Phase Ib/II Open-Label, Dose Escalation and Expansion Study of a selective HDAC Class I HIV Excluded, R/R pathologically confirmed EBV+ lymphoid malignancy or Open to accrual Santiago Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr inhibitor lymphoproliferative disease (LPD) regardless of histologic subtype including: Virus-Associated Lymphoid Malignancies 1. EBV+ post-transplant LPD 2. EBV-associated LPD associated with acquired immunodeficiency Absence of available therapy with reasonable likelihood of cure or significant clinical benefit

Marginal Zone Lymphoma PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status O'Brien Veronica De UCI 15-18: An Open-Label, Multi-Center Phase 1 Study to Investigate the anti-CD20 x anti-CD3 Have documented CD20+ B-cell malignancy, with active disease not responsive to Suspended Santiago Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific bispecific antibody prior therapy, for whom no standard of care options exists, and for whom treatment Monoclonal Antibody, in Patients with CD20+ B-Cell Malignancies Previously with an anti-CD20 antibody may be appropriate Treated with CD20-Directed Antibody Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy Measurable disease

O'Brien Blake UCI 20-126: A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR- anti-CD19 chimeric antigen Have histologically confirmed aggressive lymphoma including DLBCL, HGBL, Pending Activation Johnson Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with receptor PMBCL, tFL, FL, MZL, MCL. No response to second or more lines of therapy. Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ANTLER) Brem Veronica De UCI 17-47: A Phase Ib/II Open-Label, Dose Escalation and Expansion Study of a selective HDAC Class I HIV Excluded, R/R pathologically confirmed EBV+ lymphoid malignancy or Open to accrual Santiago Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr inhibitor lymphoproliferative disease (LPD) regardless of histologic subtype including: Virus-Associated Lymphoid Malignancies 1. EBV+ post-transplant LPD 2. EBV-associated LPD associated with acquired immunodeficiency Absence of available therapy with reasonable likelihood of cure or significant clinical benefit

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Mantle Cell Lymphoma PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Pinter-Brown Veronica De UCI 19-58: Phase III Open-label Study on Zanubrutinib plus Rituximab versus BTK Inhibitor with CD20 No prior systemic therapy. WHO 2016 diagnosis of MCL. >70 years of age, >65 with Open to accrual Santiago Bendamustine plus Rituximab in Patients with Previously Untreated Mantle monoclonal antibody comobodities. Measurable disease = 1 nodal lesion > 1.5cm, 1 extranodal lesion > Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation 1cm

O'Brien Blake UCI 20-126: A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR- anti-CD19 chimeric antigen Have histologically confirmed aggressive lymphoma including DLBCL, HGBL, Pending Activation Johnson Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with receptor PMBCL, tFL, FL, MZL, MCL. No response to second or more lines of therapy. Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ANTLER) O'Brien Veronica De UCI 15-18: An Open-Label, Multi-Center Phase 1 Study to Investigate the anti-CD20 x anti-CD3 Have documented CD20+ B-cell malignancy, with active disease not responsive to priSuspended Santiago Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific bispecific antibody Monoclonal Antibody, in Patients with CD20+ B-Cell Malignancies Previously Treated with CD20-Directed Antibody Brem Blake JohnsonECOG-EA4151: A Randomized Phase III Trial of Consolidation with anti-CD20 with HSCT Must have tissue from original diagnositc biopsy available for submission. Open to accrual Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative Fir

Diffuse Large B-Cell Lymphoma PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Brem Blake A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study anti-CD20 + 2nd Newly diagnosed non-germinal center diffuse large B-cell lymphoma. Pending activation Johnson Comparing the Efficacy and Safety of Rituximab, Cyclophosphamide, generation BTK inhibitor >65 years of age. Doxorubicin, Vincristine, and Prednisone (R-CHOP) Alone Versus in Combination with Acalabrutinib in Subjects 65 Years or under with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma

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Hodgkin's Lymphoma PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Brem Veronica De UCI 17-47: A Phase Ib/II Open-Label, Dose Escalation and Expansion Study of a selective HDAC Class I HIV Excluded, R/R pathologically confirmed EBV+ lymphoid malignancy or Open to accrual Santiago Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr inhibitor lymphoproliferative disease (LPD) regardless of histologic subtype including: Virus-Associated Lymphoid Malignancies 1. EBV+ post-transplant LPD 2. EBV-associated LPD associated with acquired immunodeficiency including HIV- positive meeting certain criteria Absence of available therapy with reasonable likelihood of cure or significant clinical benefit

Brem Veronica De S1826: A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or PD1-inhibitor vs. ADC Newly diagnosed Advanced Stage Classical Hodgkins Lymphoma Open to Accrual Santiago Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 years) with CD30 antibody Stage III/IV Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Waldenstrom’s Macroglobulinemia and other NHL subtypes PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Brem Veronica De UCI 17-47: A Phase Ib/II Open-Label, Dose Escalation and Expansion Study of a selective HDAC Class I HIV Excluded, R/R pathologically confirmed EBV+ lymphoid malignancy or Open to accrual Santiago Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr inhibitor lymphoproliferative disease (LPD) regardless of histologic subtype including: Virus-Associated Lymphoid Malignancies 1. EBV+ post-transplant LPD 2. EBV-associated LPD associated with acquired immunodeficiency Absence of available therapy with reasonable likelihood of cure or significant clinical benefit

O'Brien Veronica De UCI 15-18: An Open-Label, Multi-Center Phase 1 Study to Investigate the anti-CD20 x anti-CD3 Have documented CD20+ B-cell malignancy, with active disease not responsive to Suspended Santiago Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific bispecific antibody prior therapy, for whom no standard of care options exists, and for whom treatment Monoclonal Antibody, in Patients with CD20+ B-Cell Malignancies Previously with an anti-CD20 antibody may be appropriate Treated with CD20-Directed Antibody Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy Measurable disease

Cutaneous T-Cell Lymphoma PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status

Peripheral T-Cell Lymphoma PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Pinter-Brown Veronica De UCI 18-34: A Multi-Center, Phase II, Open-label, Parallel Cohort Study of dual Diagnosis of one of the following histologic subtypes of PTCL (PTCL-NOS, AITL, Open to accrual Santiago Efficacy and Safety of Duvelisib in Patients with Relapsed or Refractory inhibitor of PI3K-δ,γ ALCL OR NKTL) Peripheral T-cell Lymphoma (PTCL) Received at least 2 cycles of one prior regimen administered with curative intent Measurable disease as defined by IWG for PTCL

Supportive Care PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status

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Correlative PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Fleischman UCI 14-03: Role of Inflammation in the Pathogenesis of Myeloproliferative Open to accrual Neoplasm Brem Chang Shim UCI 16-70: Evaluation of Mitochondrial Priming in T Cell Lymphomas Open to accrual Fruman UCI 15-65: Effect of candidate blood cancer therapies on normal human Pending activation lymphocytes O'Brien NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural • Actively undergoing cancer treatment (chemotherapy, targeted therapy, Open to accrual History Study immunotherapy, and/or radiation therapy) or follow-up care treatment that requires regular visits to UCI Health - Orange or Newport • Must be currently testing for SARS-CoV-2 or has had first positive test < 14 days

Fortier UCI 19-27 Influence of Acculturation and Social Support on Health-Related Open to accrual Quality of Life in Acute Lymphoblastic Leukemia Survivors

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