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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of participants classified as achieving overall response of complete remission(CR: \< 5% blast in a bone marrow/and platelet \>100/and ANC \>1) or CR without platelet recovery (CRp: \< 5% blast in a bone marrow/and platelet \<100/and ANC \>1) or CR with insufficient hematological recovery (CRi: \< 5% blast in a bone marrow/and platelet \>100/and ANC \<1) post transplant.

Interventions

  • DRUG Fludarabine
  • RADIATION Total Body Irradiation (TBI)
  • DRUG Busulfan
  • DRUG Thymoglobulin
  • DRUG Clofarabine

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2015-09-14
Est. Completion 2021-09-22
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02441803 record still lists

NCT02441803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.

NCT02441803 does not publish any study locations in the registry export this page uses.

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.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT02441803's enrollment target sits among peer trials

11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02441803, the US trial registry maintained by the National Library of Medicine. NCT02441803 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.