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Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)

NCT00941928 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-05-22

Study results available
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Summary

The goal of this clinical research study is to learn if transferring the donor's NK cells, in combination with an antibody called epratuzumab and low-dose interleukin (IL-2), into your body can be done safely. Researchers want to find out if the infused NK cells will survive after the infusion and if the NK cell infusion helps to destroy cancer cells in the recipient's body and possibly to help control the disease.

Primary Objectives:

· Evaluate the feasibility of collecting an adequate number of natural killer (NK) cells from a donor and evaluate the safety of a haploidentical donor-derived NK cell infusion, Epratuzumab, and low-dose interleukin-2 (IL-2).

Secondary Objectives:

* Quantification and persistence of the infused donor NK cell in vivo;
* Quantification and persistence of cytokine levels;
* Assessment of NK cell immunophenotype and function;
* Correlate above with anti-tumor effect.

Conditions

Interventions

DRUG

Epratuzumab

360 mg/m\^2 once a day by vein on Day -4, Day -1 and Days 3, 6, 10, 13 and 17.

DRUG

Fludarabine

25 mg/m\^2 once a day by vein on Day -6 through Day -2 over 30 minutes.

DRUG

Cyclophosphamide

60 mg/kg once a day by vein on Days -5 and -4 over 2 hours.

DRUG

Mesna

12 mg/kg by vein 5 times per day on Days -5 and -4 over 15 minutes.

PROCEDURE

Infusion of NK cells

Transplant of Haploidentical NK cells by vein on Day 0.

DRUG

Interleukin-2

Subcutaneous injections three times a week for 9 doses on Days 0 to 21.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Anna Franklin, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT00941928 on ClinicalTrials.gov