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NCT01621477 · ClinicalTrials.gov registry record · Phase 2
T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01621477: Clinical Trial Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT01621477 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621477, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The primary aim of this protocol is to evaluate if the one-year survival is significantly improved in the group of patients who receive a T-cell replete haploidentical donor hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen. Study population will consist of patients (21 years or under) with hematologic malignancies that have relapsed or are refractory after prior allogeneic transplant. Toxicity will be evaluated by the rate of transplant related mortality and the rates of moderate and severe graft-versus-host disease (GvHD) at day 100. The investigators will describe event-free, and disease-free survival at one year, as well as the rates of hematopoietic recovery and donor engraftment and study comprehensively immune reconstitution following T-cell replete haploidentical transplantation.
Primary Outcome
Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.
Interventions
- DRUG Plerixafor
- DRUG cyclophosphamide
- DRUG clofarabine
- DRUG cytarabine
- DRUG busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
Why NCT01621477 stopped before completion
NCT01621477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 5 interventions - of which Plerixafor is the first listed.
NCT01621477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01621477 about?
NCT01621477 is a clinical study titled "T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant". The primary aim of this protocol is to evaluate if the one-year survival is significantly improved in the group of patients who receive a T-cell replete haploidentical donor hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen. Study population will consist of pati...
What is the current status of trial NCT01621477?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2012-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01621477?
The interventions under investigation include: Plerixafor (DRUG), cyclophosphamide (DRUG), clofarabine (DRUG), cytarabine (DRUG), busulfan (DRUG).
Who is sponsoring clinical trial NCT01621477?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01621477's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 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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