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NCT00824135 · ClinicalTrials.gov registry record · Phase 1
Haploidentical Hematopoietic Stem Cell Transplantation Using A Novel Clofarabine Containing Conditioning Regimen For Patients With Refractory Hematologic Malignancies
A Phase 1 study of Hematologic Malignancies, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT00824135 is a Phase 1 study of Hematologic Malignancies that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 34 participants, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00824135, a Phase 1 study of Hematologic Malignancies, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with refractory hematologic malignancies including those who develop recurrent disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal prognosis. Historically, both regimen-related mortality and disease recurrence have been significant causes of treatment failure in this heavily pre-treated patient population. The investigators institution has utilized mismatched family member donors for these patients for several reasons: (1) Only 30% of patients have matched related donors available; (2) transplantation can be performed more rapidly since the time to unrelated donor trans-plantation averages 3 to 4 months; (3) the alloimmune reactivity of natural killer (NK) cells following haploidentical HSCT has been shown to reduce relapse rates in certain patient groups; and, (4) no other curative treatment options are available. In the present trial, the investigators propose a novel conditioning regimen using clofarabine in an effort to enhance cytotoxicity while simultaneously reducing regimen related toxicity. In this phase I trial, the goal is to determine the maximum tolerated dose (MTD) of clofarabine when used in combination with melphalan and thiotepa pre-transplant.
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Thiotepa
- DRUG Clofarabine
- PROCEDURE Stem Cell Transplantation, Hematopoietic
- OTHER OKT3
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2009-01 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00824135
The ClinicalTrials.gov registry entry for NCT00824135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematologic Malignancies appearing as the primary indexed condition, and to 5 interventions - of which Melphalan is the first listed.
NCT00824135 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT00824135 about?
NCT00824135 is a clinical study titled "Haploidentical Hematopoietic Stem Cell Transplantation Using A Novel Clofarabine Containing Conditioning Regimen For Patients With Refractory Hematologic Malignancies". Patients with refractory hematologic malignancies including those who develop recurrent disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal prognosis. Historically, both regimen-related mortality and disease recurrence have been significant causes of treatment failu...
What is the current status of trial NCT00824135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2009-01. Estimated completion is 2016-12.
What conditions does trial NCT00824135 study?
This clinical trial studies the following conditions: Hematologic Malignancies.
What interventions are being tested in trial NCT00824135?
The interventions under investigation include: Melphalan (DRUG), Thiotepa (DRUG), Clofarabine (DRUG), Stem Cell Transplantation, Hematopoietic (PROCEDURE), OKT3 (OTHER).
Who is sponsoring clinical trial NCT00824135?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00824135 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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