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NCT02484430 · ClinicalTrials.gov registry record · Phase 2
Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia
A Phase 2 study of B Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 14
- Study locations
NCT02484430: Completed Phase 2 study of B Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, sponsored by National Cancer Institute (NCI).
NCT02484430 is a Phase 2 study of B Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 1,027-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02484430, a Phase 2 study of B Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase II trial studies how well sapanisertib works in treating patients with acute lymphoblastic leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Sapanisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Complete response rate, defined to be a complete hematologic response (CR) or complete response incomplete (CRi) noted as the objective status at any time during treatment. A CR is defined as having less than 5% blasts in a non-hypocellular marrow with a granulocyte count of 1 x109/L (or above), and a platelet count of 100 x109/L (or higher) and absence of peripheral blood blasts with complete resolution of any extra medullary disease. A patient is defined as having a CRi if they meet all CR cri
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Sapanisertib
- OTHER Pharmacological Study
Study Locations (14)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
- Moffitt Cancer Center - Tampa
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Minnesota
- Mayo Clinic in Rochester - Rochester
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-04-06 |
| Est. Completion | 2024-03-05 |
| Phase | Phase 2 |
What the finished NCT02484430 record still lists
NCT02484430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,027-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower).
The record links to 6 conditions, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02484430 lists 14 locations in 9 states (California, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT02484430 about?
NCT02484430 is a clinical study titled "Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia". This phase II trial studies how well sapanisertib works in treating patients with acute lymphoblastic leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Sapanisertib may stop the growth of cancer cells by blocking some of the ...
What is the current status of trial NCT02484430?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2017-04-06. Estimated completion is 2024-03-05.
What conditions does trial NCT02484430 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Recurrent Adult Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, T Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT02484430?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sapanisertib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02484430?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02484430 being conducted?
This trial has 14 study locations across Arizona, California, District of Columbia, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02484430's enrollment target sits among peer trials
16 21st of 20 the lowest of 20 other B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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