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NCT02101853 · ClinicalTrials.gov registry record · Phase 3
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
A Phase 3 study of Recurrent B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 669
- Enrollment target
- 20
- Study locations
NCT02101853: Active Phase 3 study of Recurrent B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
NCT02101853 is a Phase 3 study of Recurrent B Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 669 participants, above the 96-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (597% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101853, a Phase 3 study of Recurrent B Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 669 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.
Primary Outcome
DFS rates 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). DFS is calculated as the time from randomization to date of first event (treatment failure, relapse, second malignancy, remission death) or date of last contact. Two-year DFS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cytarabine
- BIOLOGICAL Blinatumomab
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- DRUG Asparaginase
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
Arizona
- 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 | 669 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2026-09-16 |
| Phase | Phase 3 |
What the registry record for NCT02101853 still lists
NCT02101853 is an interventional study that assigns participants to a tested intervention. The registered 669 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (597% higher).
The record links to 1 condition, with Recurrent B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02101853 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02101853 about?
NCT02101853 is a clinical study titled "Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia". This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune sy...
What is the current status of trial NCT02101853?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 669 participants. The study started on 2014-12-17. Estimated completion is 2026-09-16.
What conditions does trial NCT02101853 study?
This clinical trial studies the following conditions: Recurrent B Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT02101853?
The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Blinatumomab (BIOLOGICAL), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Asparaginase (DRUG).
Who is sponsoring clinical trial NCT02101853?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02101853 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
Similar trials for Recurrent B Acute Lymphoblastic Leukemia
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 NCT02101853's enrollment target sits among peer trials
669 1st of 12 higher than 12 of 12 other Recurrent B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent B Acute Lymphoblastic Leukemia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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