Study Summary
This trial is studying nivolumab in combination with blinatumomab to see how well it works compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia that has come back.
Eligible Conditions
- B-Cell Acute Lymphoblastic Leukemia (ALL)
- Down Syndrome
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: From date of Group 1 randomization to date of treatment failure, relapse, disease progression, SMN or death due to any cause, assessed up to 5 years
Year 5
Event-free survival (Group 1)
Year 10
Event-free survival post-induction (Group 3)
Year 5
Event-free survival post-induction (Group 2)
Day 36
Dose-limiting toxicity
Dose-limiting toxicity (Down syndrome patients)
Incidence of adverse events (Down syndrome patients)
Incidence of adverse events in Arm A or Arm B
Day 36
MRD negative Rem-2 rate (Down syndrome patients)
MRD negative Rem-2 rate (Group 2)
Minimal residual disease (MRD) negative second remission (Rem-2) rate with blinatumomab vs with blinatumomab + nivolumab (Group 1)
Subset analyses of EFS
Subset analyses of OS
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
7 Treatment Groups
Arm G (dexamethasone, blinatumomab, nivolumab,MTX) DS patients
1 of 7
Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX)
1 of 7
Group 3, Arm E (dexamethasone, blinatumomab, MTX)
1 of 7
Group 3, Arm F (dexamethasone, blinatumomab, nivolumab)
1 of 7
Group 1, Arm A (dexamethasone, blinatumomab, MTX)
1 of 7
Group 2, Arm C (dexamethasone, blinatumomab, MTX)
1 of 7
Group 1, Arm B (dexamethasone, blinatumomab, MTX)
1 of 7
Experimental Treatment
550 Total Participants · 7 Treatment Groups
Primary Treatment: Arm G (dexamethasone, blinatumomab, nivolumab,MTX) DS patients · No Placebo Group · Phase 2
Arm G (dexamethasone, blinatumomab, nivolumab,MTX) DS patientsExperimental Group · 7 Interventions: Cytarabine, Leucovorin Calcium, Dexamethasone, Nivolumab, Methotrexate, Hydrocortisone Sodium Succinate, Blinatumomab · Intervention Types: Drug, Drug, Drug, Biological, Drug, Drug, Biological
Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX)Experimental Group · 4 Interventions: Dexamethasone, Nivolumab, Methotrexate, Blinatumomab · Intervention Types: Drug, Biological, Drug, Biological
Group 3, Arm E (dexamethasone, blinatumomab, MTX)Experimental Group · 13 Interventions: Cytarabine, Leucovorin Calcium, Dexamethasone, 3-Dimensional Conformal Radiation Therapy, Cyclophosphamide, Thioguanine, Vincristine Sulfate, Methotrexate, Hydrocortisone Sodium Succinate, Pegaspargase, Etoposide, Mercaptopurine, Blinatumomab · Intervention Types: Drug, Drug, Drug, Radiation, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Biological
Group 3, Arm F (dexamethasone, blinatumomab, nivolumab)Experimental Group · 14 Interventions: Cytarabine, Leucovorin Calcium, Dexamethasone, 3-Dimensional Conformal Radiation Therapy, Cyclophosphamide, Nivolumab, Thioguanine, Vincristine Sulfate, Methotrexate, Hydrocortisone Sodium Succinate, Pegaspargase, Etoposide, Mercaptopurine, Blinatumomab · Intervention Types: Drug, Drug, Drug, Radiation, Drug, Biological, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Biological
Group 1, Arm A (dexamethasone, blinatumomab, MTX)Experimental Group · 5 Interventions: Cytarabine, Dexamethasone, Methotrexate, Hydrocortisone Sodium Succinate, Blinatumomab · Intervention Types: Drug, Drug, Drug, Drug, Biological
Group 2, Arm C (dexamethasone, blinatumomab, MTX)Experimental Group · 3 Interventions: Dexamethasone, Methotrexate, Blinatumomab · Intervention Types: Drug, Drug, Biological
Group 1, Arm B (dexamethasone, blinatumomab, MTX)Experimental Group · 6 Interventions: Cytarabine, Dexamethasone, Nivolumab, Methotrexate, Hydrocortisone Sodium Succinate, Blinatumomab · Intervention Types: Drug, Drug, Biological, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Calcium
Not yet FDA approved
Dexamethasone
FDA approved
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Cyclophosphamide
FDA approved
Nivolumab
FDA approved
Tioguanine
FDA approved
Sulfate ion
Not yet FDA approved
Methotrexate
FDA approved
Hydrocortisone succinate
FDA approved
Asparaginase Escherichia coli
FDA approved
Etoposide
FDA approved
Mercaptopurine
FDA approved
Muromonab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of group 1 randomization to date of treatment failure, relapse, disease progression, smn or death due to any cause, assessed up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,073 Previous Clinical Trials
41,138,358 Total Patients Enrolled
Stacy L CooperPrincipal InvestigatorChildren's Oncology Group
Eligibility Criteria
Age 1 - 30 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If radiation therapy was received within the last three months, the patient must wait until at least three months have passed before enrolling in the study
One possible scenario is a bone marrow relapse with involvement of the central nervous system (excluding known optic nerve/retinal and CNS chloromas) and/or testes.
occurred in three (3) of eleven (11) patients with leukemia in complete remission (CR) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Three of eleven patients who were in remission after allogeneic hematopoietic stem cell transplantation (allo-HSCT) experienced a relapse in their central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas)
Patients who have previously been treated with blinatumomab or CD19+ chimeric antigen receptor therapy will be eligible for the study, as long as their lymphoblasts retain CD19 expression.
Lansky scale can be used as an alternative to Karnofsky scale for patients with developmental delay, regardless of their age
People who want to join the study must be aged between 1 and 31.
You have a relapse of the disease in the bone marrow.
People in this study must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy.
is rare and is typically treated with intensive chemotherapy
References
- Shi, Zheng, Yiqian Zhu, Jing Zhang, and Baoan Chen. 2022. “Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia”. Hematology. Informa UK Limited. doi:10.1080/16078454.2022.2074704.
- Shi, Zheng, Yiqian Zhu, Jing Zhang, and Baoan Chen. 2022. “Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia”. Hematology. Informa UK Limited. doi:10.1080/16078454.2022.2074704.
- 2020. "A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04546399.
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Conditions
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Treatments