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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

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

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
~2590
Leucovorin Calcium
2011
Completed Phase 3
~12290
Methotrexate
2013
Completed Phase 4
~3800
Cyclophosphamide
1995
Completed Phase 3
~3780
Cytarabine
2016
Completed Phase 3
~3310
Nivolumab
2014
Completed Phase 3
~4750
Vincristine Sulfate
2005
Completed Phase 3
~10110
Pegaspargase
2005
Completed Phase 3
~9010
Thioguanine
2012
Completed Phase 4
~10830
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
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
~1210

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,603 Total Patients Enrolled
Stacy L CooperPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there documented precedents for this particular combination of dexamethasone, nivolumab, blinatumomab, and MTX?

"Presently, 2,723 clinical trials are researching the efficacy of the Group 2 Arm D (dexamethasone, nivolumab, blinatumomab and MTX) treatment. Of these ongoing studies 549 have progressed to Phase 3. Whilst Changsha in Hunan hosts many such tests for this therapy, there are 106,494 other locations conducting similar research worldwide."

Answered by AI

To what extent is participation in this clinical trial expanding?

"This research requires the enrolment of 550 appropriately qualified participants. Eligible individuals can receive treatment from two primary sites, University of Minnesota/Masonic Cancer Center in Minneapolis and Saint Christopher's Hospital for Children in Philadelphia."

Answered by AI

Is it permissible for individuals below a certain age to join this experiment?

"The minimum age for entry into this trial is 1 year and the cut off point for participation is 30 years."

Answered by AI

How many US-based facilities are presently conducting this clinical trial?

"This clinical trial has recruited 100 patients from the University of Minnesota/Masonic Cancer Center in Minneapolis, Saint Christopher's Hospital for Children in Philadelphia and Beaumont Children's Hospital-Royal Oak in Royal Oak. There are also another 97 sites enrolling participants."

Answered by AI

To which population is this medical research open?

"The requirements for this medical trial dictate that participants must have down syndrome and be aged between 1 year old up to 30 years. A total of 550 people are expected to join the study."

Answered by AI

Are there currently any openings for this research endeavor?

"Affirmative. According to information available on clinicaltrials.gov, recruitment for this trial began in December of 2020 and the data was last edited at the end of November 2022. 550 patients are being sought from 100 medical centres around the globe."

Answered by AI

Has the combination of dexamethasone, nivolumab, blinatumomab and MTX in Group 2 Arm D received regulatory approval?

"Our team at Power assigned Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX) a rating of two due to the lack of clinical data indicating efficacy and presence of safety-related information."

Answered by AI

To what kind of medical condition is the Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX) regimen typically applied?

"Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX) is usually prescribed for macular edema. It might also be applied to treat squamous cell carcinoma and pheochromocytomas as well as a number of ophthalmic conditions."

Answered by AI
Recent research and studies
HematologyJournal
Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia
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.
HematologyJournal
Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia
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.
clinicaltrials.govStudy
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
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.
~306 spots leftby Jun 2028
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