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NCT00402558 · ClinicalTrials.gov registry record · Phase 1

Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

A Phase 1 study of Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT00402558 is a Phase 1 study of Leukemia and Myelodysplastic Syndrome that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00402558, a Phase 1 study of Leukemia and Myelodysplastic Syndrome, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours who has certain genetic type in their blood called HLA, that almost matches yours. The stem cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or unrelated donor. The safety of this treatment will also be studied.

Interventions

  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG G-CSF
  • DRUG Thymoglobulin
  • PROCEDURE Alloreactive NK Infusion

Study Locations (1)

Texas

  • UT MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2006-05
Est. Completion 2014-04
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00402558

The ClinicalTrials.gov registry entry for NCT00402558 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.

NCT00402558 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00402558 about?

NCT00402558 is a clinical study titled "Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated ...

What is the current status of trial NCT00402558?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2006-05. Estimated completion is 2014-04.

What conditions does trial NCT00402558 study?

This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndrome.

What interventions are being tested in trial NCT00402558?

The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), G-CSF (DRUG), Thymoglobulin (DRUG), Alloreactive NK Infusion (PROCEDURE).

Who is sponsoring clinical trial NCT00402558?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00402558 being conducted?

This trial has 1 study location across Texas. 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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