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NCT01904136 · ClinicalTrials.gov registry record · Phase 1

Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

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

Completed
Registry status
Phase 1
Development phase
54
Enrollment target
1
Study location

NCT01904136 is a Phase 1 study of Myelodysplastic Syndrome and Recurrent Acute Myeloid Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 54 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01904136, a Phase 1 study of Myelodysplastic Syndrome and Recurrent Acute Myeloid Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.

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

Study Summary

This phase I/II studies the side effects and best dose of natural killer cells before and after donor stem cell transplant and to see how well they work in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia. Giving chemotherapy with or without total body irradiation before a donor peripheral blood stem cell or bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • OTHER Laboratory Biomarker Analysis
  • PROCEDURE Bone Marrow Transplantation
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2014-04-22
Est. Completion 2022-02-28
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT01904136

The ClinicalTrials.gov registry entry for NCT01904136 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (74% 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 9 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01904136 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT01904136 about?

NCT01904136 is a clinical study titled "Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia". This phase I/II studies the side effects and best dose of natural killer cells before and after donor stem cell transplant and to see how well they work in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia. Giving chemotherapy with or without to...

What is the current status of trial NCT01904136?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2014-04-22. Estimated completion is 2022-02-28.

What conditions does trial NCT01904136 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Therapy-Related Acute Myeloid Leukemia.

What interventions are being tested in trial NCT01904136?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Laboratory Biomarker Analysis (OTHER), Bone Marrow Transplantation (PROCEDURE), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT01904136?

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

Where is trial NCT01904136 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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