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Monoclonal Antibodies

Group 1, Arm B (dexamethasone, blinatumomab, MTX) for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Stacy L Cooper
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival post-induction (Group 3)
Minimal residual disease (MRD) negative second remission (Rem-2) rate with blinatumomab vs with blinatumomab + nivolumab (Group 1)
Secondary outcome measures
Dose-limiting toxicity
Event-free survival post-induction (Group 2)
Other outcome measures
Dose-limiting toxicity (Down syndrome patients)
Event-free survival (Group 1)
Incidence of adverse events (Down syndrome patients)
+5 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Group 3, Arm F (dexamethasone, blinatumomab, nivolumab)Experimental Treatment14 Interventions
See Outline section
Group II: Group 3, Arm E (dexamethasone, blinatumomab, MTX)Experimental Treatment13 Interventions
See Outline section
Group III: Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX)Experimental Treatment4 Interventions
Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle 1 proceed to cycle 2.
Group IV: Group 2, Arm C (dexamethasone, blinatumomab, MTX)Experimental Treatment3 Interventions
Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1 and 2, and methotrexate IT on days 1 and 15 of cycles 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal therapy is given < 7 days prior to the start of this cycle). Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle 1 proceed to cycle 2.
Group V: Group 1, Arm B (dexamethasone, blinatumomab, MTX)Experimental Treatment6 Interventions
Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle 1 proceed to cycle 2.
Group VI: Group 1, Arm A (dexamethasone, blinatumomab, MTX)Experimental Treatment5 Interventions
ARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1, 15, and 36 of cycle 1 (MTX, cytarabine, and ITT on day 1 may be omitted if intrathecal therapy was given < 7 days prior to the start of this cycle), and MTX IT, cytarabine IT, or ITT IT on days 15 and 36 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle 1 proceed to cycle 2.
Group VII: Arm G (dexamethasone, blinatumomab, nivolumab,MTX) DS patientsExperimental Treatment7 Interventions
Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2, and MTX IT, cytarabine IT, or ITT IT on days 1,15, and 36 of cycle 1 (MTX, cytarabine, and ITT on day 1 may be omitted if intrathecal therapy was given < 7 days prior to the start this cycle 1), MTX IT, cytarabine IT, or ITT IT on days 15 and 36 of cycle 2, and leucovorin calcium IV or PO q6h for 2 doses on days 2, 16 and 37 of cycle 1 and q6h for 2 doses on days 16 and 37 of cycle 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2640
Leucovorin Calcium
2011
Completed Phase 3
~12310
Methotrexate
2013
Completed Phase 4
~3800
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Nivolumab
2014
Completed Phase 3
~4740
Vincristine Sulfate
2005
Completed Phase 3
~10160
Pegaspargase
2005
Completed Phase 3
~9010
Thioguanine
2012
Completed Phase 4
~10830
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Hydrocortisone Sodium Succinate
2008
Completed Phase 3
~70
Etoposide
2010
Completed Phase 3
~2440
Mercaptopurine
2012
Completed Phase 4
~12330
Blinatumomab
2014
Completed Phase 3
~1230

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,958,851 Total Patients Enrolled
Stacy L CooperPrincipal InvestigatorChildren's Oncology Group
~287 spots leftby Jun 2028
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