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NCT00006251 · ClinicalTrials.gov registry record · Phase 1

Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer

A Phase 1 study of Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
2
Study locations

NCT00006251 is a Phase 1 study of Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 21 participants, below the 59-participant average among 25 other Anaplastic Large Cell Lymphoma trials with a reported enrollment target (64% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00006251, a Phase 1 study of Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
2
Study locations

Study Summary

This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and donor stem cell transplant followed by cyclosporine, mycophenolate mofetil, and donor lymphocyte infusion in treating patients with hematopoietic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also keep the patient's immune response from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Interventions

  • DRUG fludarabine phosphate
  • DRUG cyclosporine
  • RADIATION total-body irradiation
  • DRUG mycophenolate mofetil
  • PROCEDURE nonmyeloablative allogeneic hematopoietic stem cell transplantation

Study Locations (2)

Washington

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle

Other

  • University of Torino - Torino

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2000-05
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT00006251

The ClinicalTrials.gov registry entry for NCT00006251 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 59-participant average among 25 other Anaplastic Large Cell Lymphoma trials with a reported enrollment target (64% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Anaplastic Large Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which fludarabine phosphate is the first listed.

NCT00006251 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Washington, Other.

Frequently Asked Questions

What is clinical trial NCT00006251 about?

NCT00006251 is a clinical study titled "Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer". This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and donor stem cell transplant followed by cyclosporine, mycophenolate mofetil, and donor lymphocyte infusion in treating patients with hematopoietic cancer. Giving low doses of chemotherapy, such as fludarabine phos...

What is the current status of trial NCT00006251?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2000-05.

What conditions does trial NCT00006251 study?

This clinical trial studies the following conditions: Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Acute Undifferentiated Leukemia, Childhood Myelodysplastic Syndromes.

What interventions are being tested in trial NCT00006251?

The interventions under investigation include: fludarabine phosphate (DRUG), cyclosporine (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG), nonmyeloablative allogeneic hematopoietic stem cell transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT00006251?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00006251 being conducted?

This trial has 2 study locations across Washington. 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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