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COMPLETED Phase 2

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer

NCT00053196 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system 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 immunosuppressive therapy after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.

Interventions

  • BIOLOGICAL G-CSF
  • DRUG fludarabine phosphate
  • DRUG methotrexate
  • DRUG busulfan
  • BIOLOGICAL anti-thymocyte globulin

Study Locations (12)

Delaware

  • Beebe Medical Center — Lewes
  • CCOP - Christiana Care Health Services — Newark
  • St. Francis Hospital — Wilmington

California

  • Rebecca and John Moores UCSD Cancer Center — La Jolla

Maryland

  • Union Hospital Cancer Center at Union Hospital — Elkton MD

Missouri

  • Siteman Cancer Center at Barnes-Jewish Hospital — St Louis

New Jersey

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees — Voorhees Township

New York

  • Roswell Park Cancer Institute — Buffalo

North Carolina

  • Wake Forest University Comprehensive Cancer Center — Winston-Salem

Ohio

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University — Columbus

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2002-12
Est. Completion 2010-08
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00053196

The ClinicalTrials.gov registry entry for NCT00053196 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 82 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 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions — of which G-CSF is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00053196 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Delaware, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00053196 about?

NCT00053196 is a clinical study titled "Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer". RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replac...

What is the current status of trial NCT00053196?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2002-12. Estimated completion is 2010-08.

What conditions does trial NCT00053196 study?

This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00053196?

The interventions under investigation include: G-CSF (BIOLOGICAL), fludarabine phosphate (DRUG), methotrexate (DRUG), busulfan (DRUG), anti-thymocyte globulin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00053196?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00053196 being conducted?

This trial has 12 study locations across California, Delaware, Maryland, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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