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NCT04546399 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
A Phase 2 study of Down Syndrome and Recurrent B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 461
- Enrollment target
- 20
- Study locations
NCT04546399: Recruiting Phase 2 study of Down Syndrome and Recurrent B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
NCT04546399 is a Phase 2 study of Down Syndrome and Recurrent B Acute Lymphoblastic Leukemia that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 461 participants, below the 2,463-participant average among 54 other Down Syndrome trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04546399, a Phase 2 study of Down Syndrome and Recurrent B Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 461 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.
Primary Outcome
MRD negative Rem-2 be defined as Rem-2 (i.e., achievement of MRD \< 1% blasts by flow cytometry and resolution of extramedullary disease (for CNS disease, requires CNS 1) ) and bone marrow with MRD \< 0.01% by flow cytometry. MRD negative Rem-2 rate between Arm A vs Arm B will be compared using a one-sided Z test of proportions with Type I error of 0.10. Interim analysis will be conducted to monitor for futility. The futility boundaries are based on testing the alternative hypothesis at the 0.06
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- BIOLOGICAL Blinatumomab
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Bellflower - Bellflower
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fontana - Fontana
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
Arizona
- Kingman Regional Medical Center - Kingman
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What NCT04546399 shows while recruiting
NCT04546399 is an interventional study that assigns participants to a tested intervention. The registered 461 participants enrollment target is mid-sized for trials with a published cap, below the 2,463-participant average among 54 other Down Syndrome trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04546399 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04546399 about?
NCT04546399 is a clinical study titled "A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)". This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab...
What is the current status of trial NCT04546399?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 461 participants. The study started on 2020-12-17. Estimated completion is 2028-06-30.
What conditions does trial NCT04546399 study?
This clinical trial studies the following conditions: Down Syndrome, Recurrent B Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT04546399?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Blinatumomab (BIOLOGICAL), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04546399?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04546399 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04546399's enrollment target sits among peer trials
461 11th of 54 higher than 44 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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