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NCT02003222 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
A Phase 3 study of Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
- 20
- Study locations
NCT02003222 is a Phase 3 study of Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 488 participants, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT02003222, a Phase 3 study of Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. 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. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- BIOLOGICAL Blinatumomab
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Community Cancer Institute - Clovis
- University Oncology Associates - Clovis
Arizona
- Kingman Regional Medical Center - Kingman
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- University of Arkansas for Medical Sciences - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2014-05-19 |
| Est. Completion | 2026-03-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02003222
The ClinicalTrials.gov registry entry for NCT02003222 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (29% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02003222 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02003222 about?
NCT02003222 is a clinical study titled "Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia". This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute...
What is the current status of trial NCT02003222?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2014-05-19. Estimated completion is 2026-03-25.
What conditions does trial NCT02003222 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative.
What interventions are being tested in trial NCT02003222?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Blinatumomab (BIOLOGICAL), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT02003222?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02003222 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.
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