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NCT00070135 · ClinicalTrials.gov registry record · Phase 2

Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission

A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 2
Development phase
121
Enrollment target

NCT00070135 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 121 participants.

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The verdict

NCT00070135, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 2
Development phase
121 participants
Enrollment target

Study Summary

This phase II trial studies how well fludarabine and busulfan followed by a donor (allogeneic) stem cell transplant work in treating older patients with acute myeloid leukemia that is in first complete remission. Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stops 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. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus, methotrexate, and rabbit antithymocyte globulin before or after the transplant may stop this from happening.

Interventions

  • BIOLOGICAL Anti-Thymocyte Globulin
  • DRUG fludarabine phosphate
  • DRUG methotrexate
  • BIOLOGICAL filgrastim
  • DRUG busulfan

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2004-01
Est. Completion 2016-06-15
Phase Phase 2

What the Registry Record Tells You About NCT00070135

The ClinicalTrials.gov registry entry for NCT00070135 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

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

NCT00070135 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00070135 about?

NCT00070135 is a clinical study titled "Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission". This phase II trial studies how well fludarabine and busulfan followed by a donor (allogeneic) stem cell transplant work in treating older patients with acute myeloid leukemia that is in first complete remission. Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peri...

What is the current status of trial NCT00070135?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2004-01. Estimated completion is 2016-06-15.

What interventions are being tested in trial NCT00070135?

The interventions under investigation include: Anti-Thymocyte Globulin (BIOLOGICAL), fludarabine phosphate (DRUG), methotrexate (DRUG), filgrastim (BIOLOGICAL), busulfan (DRUG).

Who is sponsoring clinical trial NCT00070135?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

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

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