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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01621477
The ClinicalTrials.gov registry entry for NCT01621477 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Plerixafor is the first listed.
NCT01621477 reports 0 study locations.
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.
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