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NCT01390402 · ClinicalTrials.gov registry record · Phase 2

Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG

A Phase 2 study of Leukemia and Chronic Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
6
Enrollment target
1
Study location

NCT01390402: Completed Phase 2 study of Leukemia and Chronic Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.

NCT01390402 is a Phase 2 study of Leukemia and Chronic Myelogenous Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 6 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (99% 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

NCT01390402, a Phase 2 study of Leukemia and Chronic Myelogenous Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical research study is to learn if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied.

Primary Outcome

Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.

Conditions Studied

Leukemia Chronic Myelogenous Leukemia

Interventions

  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Interleukin-2
  • DRUG Anti-Thymocyte Globulin
  • PROCEDURE NK cell infusion:

Study Locations (1)

Texas

  • University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2012-01
Est. Completion 2014-11
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01390402 record still lists

NCT01390402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (99% lower).

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.

NCT01390402 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01390402 about?

NCT01390402 is a clinical study titled "Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG". The goal of this clinical research study is to learn if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied.

What is the current status of trial NCT01390402?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-01. Estimated completion is 2014-11.

What conditions does trial NCT01390402 study?

This clinical trial studies the following conditions: Leukemia, Chronic Myelogenous Leukemia.

What interventions are being tested in trial NCT01390402?

The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Interleukin-2 (DRUG), Anti-Thymocyte Globulin (DRUG), NK cell infusion: (PROCEDURE).

Who is sponsoring clinical trial NCT01390402?

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

Where is trial NCT01390402 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 Leukemia

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 NCT01390402's enrollment target sits among peer trials

6 225th of 233 higher than 8 of 233 other Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leukemia 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 NCT01390402, the US trial registry maintained by the National Library of Medicine. NCT01390402 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.