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NCT02441803 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT02441803: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02441803 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02441803, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Objectives: Primary Objectives: 1. To determine the safety and feasibility of allogeneic hematopoietic stem cell transplantation (AHSCT) as initial salvage treatment for patients with primary induction failure (PIF) acute myeloid leukemia (AML). 2. To determine efficacy of AHSCT following decitabine, clofarabine, idarubicin, and cytarabine (DCIA) salvage chemotherapy evaluated by overall response rate (RR), defined as complete response (CR) or CR without platelet recovery (CRp) or CR with insufficient hematological recovery (CRi). Secondary Objectives: 1. To determine the percentage of patients with PIF AML eligible for AHSCT after up to 2 courses of induction chemotherapy. 2. To determine the early treatment-related mortality (TRM) (within first 4 weeks of first salvage chemotherapy regimen with DCIA and day 100 TRM after AHSCT. 3. To determine the efficacy DCIA regimen as salvage chemotherapy for patients with PIF AML (% of patients who achieve \</=5% bone marrow blasts prior to AHSCT. 4. To determine the TRM at 1 year, relapse rate (RR), overall survival (OS) and event-free survival (EFS) for patients with PIF AML treated with DCIA followed by early AHSCT.
Interventions
- DRUG Fludarabine
- RADIATION Total Body Irradiation (TBI)
- DRUG Busulfan
- DRUG Thymoglobulin
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-09-14 |
| Est. Completion | 2021-09-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02441803
The ClinicalTrials.gov registry entry for NCT02441803 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT02441803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02441803 about?
NCT02441803 is a clinical study titled "Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)". Objectives: Primary Objectives: 1. To determine the safety and feasibility of allogeneic hematopoietic stem cell transplantation (AHSCT) as initial salvage treatment for patients with primary induction failure (PIF) acute myeloid leukemia (AML). 2. To determine efficacy of AHSCT following decitabi...
What is the current status of trial NCT02441803?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2015-09-14. Estimated completion is 2021-09-22.
What interventions are being tested in trial NCT02441803?
The interventions under investigation include: Fludarabine (DRUG), Total Body Irradiation (TBI) (RADIATION), Busulfan (DRUG), Thymoglobulin (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT02441803?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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