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NCT00025662 · ClinicalTrials.gov registry record · Phase 2

Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS

A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT00025662 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 23 participants.

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The verdict

NCT00025662, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

This study will evaluate the safety and effectiveness of stem cell transplantation in which the donors T lymphocytes have undergone "selective depletion." Certain patients with cancers of the blood undergo transplantation of donated stem cells to generate new and normally functioning bone marrow. In addition to producing the new bone marrow, the donor's T-lymphocytes also fight any tumor cells that might have remained in the body. This attack on tumor cells is called a "graft-versus-leukemia" (GVL) effect. However, another type of T-lymphocyte from the donor may cause what is called "graft-versus-host-disease" (GVHD), in which the donor cells recognize the patient's cells as foreign and mount an immune response to reject them. Selective depletion is a technique that was developed to remove the T-lymphocytes that cause harmful GVHD, while keeping those that produce the desirable GVL effect.

Interventions

  • DRUG RFT5-SMPT-dgA
  • DRUG Isolex system

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2001-05
Est. Completion 2008-02
Phase Phase 2

What the Registry Record Tells You About NCT00025662

The ClinicalTrials.gov registry entry for NCT00025662 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which RFT5-SMPT-dgA is the first listed.

NCT00025662 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00025662 about?

NCT00025662 is a clinical study titled "Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS". This study will evaluate the safety and effectiveness of stem cell transplantation in which the donors T lymphocytes have undergone "selective depletion." Certain patients with cancers of the blood undergo transplantation of donated stem cells to generate new and normally functioning bone marrow. In...

What is the current status of trial NCT00025662?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2001-05. Estimated completion is 2008-02.

What interventions are being tested in trial NCT00025662?

The interventions under investigation include: RFT5-SMPT-dgA (DRUG), Isolex system (DRUG).

Who is sponsoring clinical trial NCT00025662?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 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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