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NCT00152139 · ClinicalTrials.gov registry record · Phase 3

Stem Cell Transplantation for Patients With Hematologic Malignancies

A Phase 3 study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
Phase 3
Development phase
33
Enrollment target

NCT00152139 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 33 participants.

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The verdict

NCT00152139, a Phase 3 study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
Phase 3
Development phase
33 participants
Enrollment target

Study Summary

Childhood leukemias which cannot be cured by chemotherapy alone may be effectively treated by allogeneic bone marrow transplantation. Moreover, for patients with chronic myelogenous leukemia (CML), allogeneic hematopoietic stem cell transplantation (HSCT) is the only proven curative modality of treatment. Patients who have received hematopoietic stem cells from an HLA matched sibling donor have proven to be less at risk for disease relapse and regimen related toxicity. However, about 70% of patients in need of HSCT do not have an HLA matched sibling donor. This necessitates the search for alternative donors, which may increase the risk of a poor outcome. The nature of the hematopoietic stem cell graft has been implicated as a primary factor determining these outcomes. The standard stem cell graft has been unmanipulated bone marrow, but recently several advantages of T-lymphocyte depleted bone marrow and mobilized peripheral blood progenitor cells (PBPC) have been demonstrated. However, T-cell depletion may increase the risk of infectious complications and leukemic recurrence while an unmanipulated stem cell graft may increase the risk of graft vs. host disease (GVHD). A key element in long range strategies in improving outcomes for patients undergoing matched unrelated donor (MUD) HSCT is to provide the optimal graft. The primary objective of this clinical trial is to estimate the incidence of acute GVHD in pediatric patients with hematologic malignancies who receive HSCT with an unmanipulated marrow graft. The results of this study can be used as the foundation for future trials related to engineering unrelated donor graft.

Interventions

  • PROCEDURE Allogeneic Stem Cell Transplantation
  • DRUG Chemotherapy and antibodies

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2002-05
Est. Completion 2009-01
Phase Phase 3

What the Registry Record Tells You About NCT00152139

The ClinicalTrials.gov registry entry for NCT00152139 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Allogeneic Stem Cell Transplantation is the first listed.

NCT00152139 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00152139 about?

NCT00152139 is a clinical study titled "Stem Cell Transplantation for Patients With Hematologic Malignancies". Childhood leukemias which cannot be cured by chemotherapy alone may be effectively treated by allogeneic bone marrow transplantation. Moreover, for patients with chronic myelogenous leukemia (CML), allogeneic hematopoietic stem cell transplantation (HSCT) is the only proven curative modality of trea...

What is the current status of trial NCT00152139?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2002-05. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00152139?

The interventions under investigation include: Allogeneic Stem Cell Transplantation (PROCEDURE), Chemotherapy and antibodies (DRUG).

Who is sponsoring clinical trial NCT00152139?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.