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

NCT01390402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-02-03

Study results available
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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.

Conditions

Interventions

DRUG

Fludarabine

40 mg/m2 intravenous over one (1) hour on each of four (4) consecutive days, Days -13 to -10.

DRUG

Busulfan

130 mg/ m2 by vein for 2 doses on Days -11 to -10.

PROCEDURE

NK cell infusion:

Natural killer cell infusion will be administered by vein on Day -8.

DRUG

Interleukin-2

0.5 million units subcutaneously daily for 5 days on Day -8 to day -4.

DRUG

Anti-Thymocyte Globulin

2.5 mg/kg by vein for 3 doses on Days -3 to -1.

PROCEDURE

Allogeneic related Stem Cell Transplant

Allogeneic related stem cell transplant by vein on day 0.

DRUG

Tacrolimus

Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml.

DRUG

Methotrexate

5 mg/m2 by vein Days 1, 3 and 6 post transplant.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on Day + 7, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Richard E. Champlin, MD,BS · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01390402 on ClinicalTrials.gov