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NCT02143414 · ClinicalTrials.gov registry record · Phase 2
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
A Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 20
- Study locations
NCT02143414: Active Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
NCT02143414 is a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02143414, a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Primary Outcome
To evaluate the 3-year overall survival rate in elderly participants with newly diagnosed Ph-negative ALL treated with blinatumomab followed by POMP maintenance. Overall
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Blinatumomab
- PROCEDURE Bone Marrow Aspiration and Biopsy
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- UC San Diego Moores Cancer Center - La Jolla
- Loma Linda University Medical Center - Loma Linda
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Keck Medical Center of USC Pasadena - Pasadena
Illinois
- Rush-Copley Medical Center - Aurora
- OSF Saint Joseph Medical Center - Bloomington
- Illinois CancerCare-Bloomington - Bloomington
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
Georgia
- Northside Hospital - Atlanta
- Augusta University Medical Center - Augusta
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arkansas
- John L McClellan Memorial Veterans Hospital - Little Rock
Florida
- Orlando Health Cancer Institute - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2015-06-30 |
| Est. Completion | 2027-01-26 |
| Phase | Phase 2 |
What the registry record for NCT02143414 still lists
NCT02143414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (86% lower).
The record links to 5 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02143414 names 20 study sites across 8 states, led by California, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT02143414 about?
NCT02143414 is a clinical study titled "Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia". This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune...
What is the current status of trial NCT02143414?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2015-06-30. Estimated completion is 2027-01-26.
What conditions does trial NCT02143414 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1.
What interventions are being tested in trial NCT02143414?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Blinatumomab (BIOLOGICAL), Bone Marrow Aspiration and Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02143414?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02143414 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02143414's enrollment target sits among peer trials
53 69th of 131 higher than 63 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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