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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of participants that experienced dose limiting toxicities.

Conditions Studied

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 Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive de Novo Myelodysplastic Syndrome Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive Acute Myeloid Leukemia With Gene Mutations

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
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01904136 record still lists

NCT01904136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (74% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Myelodysplastic Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01904136's enrollment target sits among peer trials

54 60th of 134 higher than 71 of 134 other Myelodysplastic Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01904136, the US trial registry maintained by the National Library of Medicine. NCT01904136 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.