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Prot SAP 000.Pdf i AALL1331 Activated: 12/08/14 Version Date: 12/19/2019 Closed: 09/30/19 Amendment #10A CHILDREN’S ONCOLOGY GROUP AALL1331 Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC# 765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) IND Sponsor for Blinatumomab: DCTD, NCI A Groupwide Phase III Study Participating Countries: Australia, Canada, New Zealand and United States THIS PROTOCOL IS FOR RESEARCH PURPOSES ONLY, AND SHOULD NOT BE COPIED, REDISTRIBUTED OR USED FOR ANY OTHER PURPOSE. MEDICAL AND SCIENTIFIC INFORMATION CONTAINED WITHIN THIS PROTOCOL IS NOT INCLUDED TO AUTHORIZE OR FACILITATE THE PRACTICE OF MEDICINE BY ANY PERSON OR ENTITY. RESEARCH MEANS A SYSTEMATIC INVESTIGATION, INCLUDING RESEARCH DEVELOPMENT, TESTING AND EVALUATION, DESIGNED TO DEVELOP OR CONTRIBUTE TO GENERALIZABLE KNOWLEDGE. THIS PROTOCOL IS THE RESEARCH PLAN DEVELOPED BY THE CHILDREN’S ONCOLOGY GROUP TO INVESTIGATE A PARTICULAR STUDY QUESTION OR SET OF STUDY QUESTIONS AND SHOULD NOT BE USED TO DIRECT THE PRACTICE OF MEDICINE BY ANY PERSON OR TO PROVIDE INDIVIDUALIZED MEDICAL CARE, TREATMENT, OR ADVICE TO ANY PATIENT OR STUDY SUBJECT. THE PROCEDURES IN THIS PROTOCOL ARE INTENDED ONLY FOR USE BY CLINICAL ONCOLOGISTS IN CAREFULLY STRUCTURED SETTINGS, AND MAY NOT PROVE TO BE MORE EFFECTIVE THAN STANDARD TREATMENT. ANY PERSON WHO REQUIRES MEDICAL CARE IS URGED TO CONSULT WITH HIS OR HER PERSONAL PHYSICIAN OR TREATING PHYSICIAN OR VISIT THE NEAREST LOCAL HOSPITAL OR HEALTHCARE INSTITUTION. STUDY CHAIR Patrick Brown, MD 1650 Orleans Street, CRB1 RM 2M49 Baltimore, MD. 21231 Phone: (410) 614-4915 Fax: (410) 955-8897 E-mail: [email protected] Version Date: 12/19/2019 1 AALL1331 ABBREVIATIONS Abbreviation Term aGVHD Acute graft versus host disease B-ALL B-Lymphoblastic Leukemia CR Complete remission DFS Disease free survival GVHD Graft vs. host disease HR High risk HSCT Hematopoietic stem cell transplant IEM Isolated extramedullary IR Intermediate risk IS Immune suppression LR Low risk MRD Minimal residual disease PFS Progression free survival Ph+ Philadelphia chromosome positive TF Treatment failure TKI Tyrosine kinase inhibitor URD Unrelated Donor Version Date: 12/19/2019 2 THIS PROTOCOL IS FOR RESEARCH PURPOSES ONLY, SEE PAGE 1 FOR USAGE POLICY AALL1331 TABLE OF CONTENTS SECTION PAGE STUDY COMMITTEE 12 ABSTRACT 15 EXPERIMENTAL DESIGN SCHEMA 16 1.0 GOALS AND OBJECTIVES (SCIENTIFIC AIMS) 17 1.1 Primary Aims 17 1.1.1 To compare disease free survival (DFS) of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). (Closed effective September 18, 2019) 17 1.1.2 To compare DFS of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). 17 1.2 Secondary Aims 17 1.2.1 To compare overall survival (OS) of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5 week blocks of blinatumomab (HR/IR Randomization). (Closed effective September 18, 2019) 17 1.2.2 To compare OS of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). 17 1.3 Exploratory Aims 17 1.3.1 To compare the rates of MRD ≥ 0.01% at the end of Block 2 and Block 3 for HR and IR relapse B-ALL patients in HR/IR randomization. (Closed effective September 18, 2019) 17 1.3.2 To estimate, for treatment failure (TF) patients not previously receiving blinatumomab, the hematologic complete remission rate (CR), rate of MRD < 0.01%, and proportion able to proceed to hematopoietic stem cell transplant (HSCT) in CR after treatment with blinatumomab. 17 1.3.3 To assess the feasibility and safety of rapid taper of immune suppression for the subset of HSCT patients with MRD ≥ 0.01% pre- and/or post-HSCT with no acute graft versus host disease (aGVHD). 17 1.3.4 To evaluate blinatumomab pharmacokinetics (PK) and explore exposure- response relationships for measures of safety and effectiveness. 17 2.0 BACKGROUND 18 2.1 Overview 18 2.2 Rationale for Selected Approach and Trial Design 18 2.2.1 Rationale for Consolidated First Relapse B-ALL Trial 18 2.2.2 Rationale for Studying Blinatumomab in First Relapse of B-ALL 19 2.2.3 Rationale for Risk Stratification 21 2.2.4 Rationale for Backbone Chemotherapy Treatment (Blocks 1, 2 and 3) 22 2.2.5 Rationale for Backbone Chemotherapy Treatment (post-Block 3) 24 2.2.6 Therapy for CNS3 Patients 24 2.2.7 Treatment of Testicular Relapse 25 Version Date: 12/19/2019 3 THIS PROTOCOL IS FOR RESEARCH PURPOSES ONLY, SEE PAGE 1 FOR USAGE POLICY AALL1331 2.2.8 Treatment Failure (TF) 26 2.2.9 Additional non-randomized Pilot Intervention for Very High Risk Subset of HSCT Recipients based on MRD and aGVHD 26 2.2.10 Rationale for closure of the HR/IR Randomization (Amendment #10) 27 3.0 STUDY ENROLLMENT PROCEDURES AND PATIENT ELIGIBILITY 28 3.1 Study Enrollment 28 3.1.1 Patient Registration 28 3.1.2 IRB Approval 28 3.1.3 Study Enrollment 29 3.1.4 Timing 30 3.1.5 Staged Consent 30 3.1.6 Risk Assignment, Randomization, and Treatment Assignment 31 3.1.7 Callbacks 32 3.1.8 Drug Preparation and Administration 33 3.1.9 Inclusion of Women and Minorities 33 3.2 Patient Eligibility Criteria 33 3.2.1 Age 33 3.2.2 Diagnosis 33 3.2.3 Prior Therapy 34 3.2.4 Performance Status 34 3.2.5 Organ Function Requirements 34 3.2.6 Exclusion Criteria 35 3.2.7 Regulatory Requirements 36 3.3 Definitions 36 4.0 TREATMENT PLAN 40 4.1 Overview of Treatment Plan 40 4.1.1 TREATMENT ASSIGNMENTS 41 4.1.2 Concomitant Therapy Restrictions 42 4.1.3 Supportive Care for Patients 15 Years and Older 43 4.2 Block 1 (All patients) - 4 Weeks Duration 44 4.2.1 Disease Evaluation Pre-Treatment 44 4.2.2 General Chemotherapy Guidelines 44 4.2.3 Block 1 Chemotherapy 44 4.2.4 Disease Evaluation End Block 1 46 4.2.5 Research Studies Block 1 46 4.2.6 HLA Tissue Typing for Hematopoietic Stem Cell Transplant 46 4.2.7 Evaluation 1 (Risk Assessment following Block 1) 46 4.3 Block 2 (LR Patients: Post-randomization) – 4 weeks duration 48 4.3.1 Criteria to Begin Block 2 Therapy 48 4.3.2 Testicular Radiation Therapy (TRT) 48 4.3.3 General Chemotherapy Guidelines 48 4.3.4 Block 2 Chemotherapy 49 4.3.5 Evaluation 2 (Disease Evaluation End Block 2) 51 Version Date: 12/19/2019 4 THIS PROTOCOL IS FOR RESEARCH PURPOSES ONLY, SEE PAGE 1 FOR USAGE POLICY AALL1331 4.3.6 Following Completion of Block 2: 51 4.4 Block 3 (LR Patients on Arm C) - 4 weeks 52 4.4.1 Criteria to Begin Block 3 Therapy 52 4.4.2 General Chemotherapy Guidelines 52 4.4.3 Block 3 Chemotherapy 52 4.4.4 Disease Evaluation End Block 3 (HR/IR Patients ONLY): 54 4.4.5 Following completion of Block 3: 54 4.5 Blinatumomab Block: Cycle 1 (HR/IR Patients in Arm B) - 5 weeks 55 4.5.1 Criteria to Begin Blinatumomab Block: Cycle 1 55 4.5.2 Testicular Radiation Therapy (TRT) 56 4.5.3 General Chemotherapy Guidelines 56 4.5.4 Blinatumomab Block: Cycle 1 Chemotherapy 56 4.5.5 Disease Evaluation End-Blinatumomab Block: Cycle 1 57 4.5.6 Following completion of Blinatumomab Block: Cycle 1 (Arm B) 57 4.6 Blinatumomab Block: Cycle 2 (HR/IR Patients in Arm B) - 5 weeks 58 4.6.1 Criteria to Begin Blinatumomab Block: Cycle 2 58 4.6.2 General Chemotherapy Guidelines 58 4.6.3 Blinatumomab Block: Cycle 2 Administration Guidelines 59 4.6.4 Disease Evaluation End-Blinatumomab Block: Cycle 2 59 4.6.5 Following completion of Blinatumomab Block: Cycle 2 (Arm B): 60 4.7 Blinatumomab-S: Cycle 1 (Salvage Therapy) - 5 weeks 61 4.7.1 Criteria to Begin Blinatumomab-S: Cycle 1 61 4.7.2 Testicular Radiation Therapy (TRT) 61 4.7.3 General Chemotherapy Guidelines 62 4.7.4 Blinatumomab-S: Cycle 1 Chemotherapy Guidelines 62 4.7.5 Disease Evaluation End Blinatumomab-S Cycle 1: 63 4.7.6 Following completion of Blinatumomab-S: Cycle 1: 63 4.8 Blinatumomab-S: Cycle 2 (Salvage Therapy) - 5 weeks 64 4.8.1 Criteria to Begin Blinatumomab-S: Cycle 2 64 4.8.2 General Chemotherapy Guidelines 64 4.8.3 Blinatumomab-S: Cycle 2 Chemotherapy 65 4.8.4 Disease Evaluation End-Blinatumomab-S: Cycle 2 65 4.8.5 Following completion of Blinatumomab-S: Cycle 2: 65 4.9 Hematopoietic Stem Cell Transplant 67 4.9.1 Overview 67 4.9.2 Preparative Regimen Administration 71 4.9.3 Preparative Regimen Administration Tables 71 4.9.4 Sanctuary Site Therapy (see Section 14.0) 73 4.9.5 Growth Factor Administration 73 4.9.6 GVHD Prophylaxis 74 4.9.7 Standard Taper of Immune Suppression 76 4.9.8 Accelerated Taper of Immune Suppression 76 4.10 Bridging Maintenance Therapy (All HR/IR Patients, as required) – up to 6 weeks 77 4.10.1 Criteria to Begin Bridging Maintenance Therapy 77 Version Date: 12/19/2019 5 THIS PROTOCOL IS FOR RESEARCH PURPOSES ONLY, SEE PAGE 1 FOR USAGE POLICY AALL1331 4.10.2 General Chemotherapy Guidelines 77 4.10.3 Bridging Maintenance Chemotherapy Guidelines 77 4.11 Continuation 1/Continuation 2 (All LR Patients) - 8 weeks 78 4.11.1 Criteria to Begin and During Continuation Therapy 78 4.11.2 General Chemotherapy Guidelines 79 4.11.3 Continuation 1/Continuation 2 Chemotherapy Guidelines 79 4.11.4 Following Continuation 1: 82 4.11.5 Following Continuation 2: 82 4.12 Maintenance Cycle 1 (All LR patients) – 12 weeks 83 4.12.1 Criteria to Begin Maintenance Therapy 83 4.12.2 Duration of Cycles in Maintenance Therapy 83 4.12.3 General Chemotherapy Guidelines 83 4.12.4 Maintenance
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