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NCT00423514 · ClinicalTrials.gov registry record · Phase 1

Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease

A Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target
1
Study location

NCT00423514 is a Phase 1 study of Leukemia and Myelodysplastic Syndromes that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 38 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00423514, a Phase 1 study of Leukemia and Myelodysplastic Syndromes, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with melphalan and thiotepa, followed by a donor stem cell transplant and to see how well it works in treating patients with high-risk and/or advanced hematologic cancer or other disease.

Interventions

  • DRUG tacrolimus
  • DRUG clofarabine
  • DRUG melphalan
  • BIOLOGICAL filgrastim
  • DRUG mycophenolate mofetil

Study Locations (1)

New York

  • Memorial Sloan-Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2006-11-20
Est. Completion 2021-06-18
Phase Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

What the Registry Record Tells You About NCT00423514

The ClinicalTrials.gov registry entry for NCT00423514 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which tacrolimus is the first listed.

NCT00423514 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00423514 about?

NCT00423514 is a clinical study titled "Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease". RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infu...

What is the current status of trial NCT00423514?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2006-11-20. Estimated completion is 2021-06-18.

What conditions does trial NCT00423514 study?

This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes, Graft-Versus-Host Disease.

What interventions are being tested in trial NCT00423514?

The interventions under investigation include: tacrolimus (DRUG), clofarabine (DRUG), melphalan (DRUG), filgrastim (BIOLOGICAL), mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00423514?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00423514 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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