Donor Natural Killer Cell Infusion in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes - Tabular View

Tracking Information

First Received Date ^ICMJE

March 15, 2006

Last Updated Date

February 6, 2009

Start Date ^ICMJE

September 2005

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Neutrophil recovery at day +28 100 day survival (Stage I) [ Designated as safety issue: No ]
Incidence of grade II-IV acute GVHD at day 100 (Stage II) [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Disease-free survival at 1 year

Change History

Complete list of historical versions of study NCT00303667 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of grade III-IV acute GVHD at day 100 [ Designated as safety issue: No ]
Incidence of chronic GVHD at 6 months [ Designated as safety issue: No ]
Relapse at 6 months [ Designated as safety issue: No ]
Survival at 100 days and 1 year [ Designated as safety issue: No ]
Comparison of other endpoints after transplant using KIR-ligand mismatched vs. matched donors [ Designated as safety issue: No ]
Incidence of toxicity associated with the use of bortezomib [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Graft failure as determine by graft-versus-host-disease at 3 months

Descriptive Information

Brief Title ^ICMJE

Donor Natural Killer Cell Infusion in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes

Official Title ^ICMJE

Reduced Intensity Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) Supplemented With Donor Natural Killer (NK) Cell Infusions

Brief Summary

RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving donor natural killer cells before the transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying how well a donor natural killer cell infusion works in treating patients who are undergoing donor stem cell transplant for acute myeloid leukemia, chronic myeloid leukemia, or myelodysplastic syndromes.

Detailed Description

OBJECTIVES:

Primary

To determine whether administration of donor NK Cells can permit engraftment and satisfactory 100 day survival after haploidentical hematopoietic stem cell transplantation (HSCT).

Secondary

To determine the incidence of multiorgan toxicity, engraftment, acute and chronic GVHD, relapse, transplant-related (non-relapse) mortality and survival after transplantation.
To compare these endpoints after transplantation using KIR-L matched vs. mismatched donors and in recipients missing 0, 1 or 2 KIR-L.
To evaluate the safety of adding bortezomib (Velcade) to the preparative regimen.

OUTLINE: This is an open-label study.

Patients receive fludarabine IV over 1 hour daily on days -17 to -13, cyclophosphamide IV over 2 hours on day -13, and undergo total body irradiation on day -12. Patients then receive an infusion of donor natural killer cells on day -12 and receive interleukin-2 on alternating days on days -10 to -2 and undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients also receive anti-thymocyte globulin IV over 4-6 hours on days 0-2.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes

Intervention ^ICMJE

Biological: anti-thymocyte globulin
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following high-risk (aggressive) myeloid malignancies:
- Acute myeloid leukemia
- Chronic myeloid leukemia
- Myelodysplastic syndromes
No fully matched related or unrelated donor available

PATIENT CHARACTERISTICS:

No HIV positivity
Hepatitis B and C negative
Not pregnant or nursing
Fertile patients must use effective contraception during and for at least 1 year after completion of study treatment

PRIOR CONCURRENT THERAPY:

Not specified

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00303667

Responsible Party

Sarah Cooley, Masonic Cancer Center at University of Minnesota

Study ID Numbers ^ICMJE

CDR0000450770, UMN-2004LS042, UMN-MT2003-23, UMN-IRB-0405M60481

Study Sponsor ^ICMJE

Masonic Cancer Center, University of Minnesota

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Sarah Cooley, MD

Masonic Cancer Center, University of Minnesota

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP