Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia

November 14, 2013 updated by: University of Colorado, Denver

A Phase II Study of Allografting to Establish Mixed or Full Donor Chimerism as Consolidative Immunotherapy for Older Patients With AML in Complete Remission Using Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy used to kill tumor cells. Infusions of donor white blood cells may decrease the body's rejection of the transplanted peripheral stem cells.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy, peripheral stem cell transplantation, and donor white blood cell infusions in treating older patients who have acute myeloid leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine whether mixed or full donor chimerism can be safely established in older patients with acute myeloid leukemia (AML) treated with nonmyeloablative conditioning comprised of low dose total body irradiation, followed by allogeneic peripheral blood stem cell transplantation, followed by unrelated donor lymphocyte infusion (DLI). II. Determine whether mixed chimerism can be safely converted to full donor chimerism in patients treated with DLI. III. Determine the potential efficacy of this regimen in AML patients who are in first remission.

OUTLINE: Conditioning: Patients undergo low dose total body irradiation followed by infusion of allogeneic peripheral blood stem cells (PBSC) on day 0. Donor lymphocyte infusions: Nonmobilized donor lymphocytes are harvested from the same HLA identical related donor on day 95 after PBSC transplantation. Eligible patients with mixed chimerism and no graft versus host disease (GVHD) receive the first donor lymphocyte infusion (DLI) on the same day that donor lymphocytes are collected. Patients who continue to have mixed chimerism and no GVHD receive the second DLI at a higher dose level on day 65 after the first DLI. Patients are followed weekly until day 90, and then monthly thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) (de novo or secondary, FAB M1, M2 and M4-7) Must be within 6 months of diagnosis Achieved a chemotherapy induced first complete remission (CR) Received 1 or more courses of consolidation chemotherapy OR AML in second or greater CR Patients with a documented first or subsequent CR may proceed to transplantation if: No morphologic diagnosis of AML or myelodysplastic syndrome Absolute neutrophil count greater than 1,000/mm3 and platelet count greater than 50,000/mm3 after any consolidation chemotherapy Availability of an HLA identical related peripheral blood stem cell donor No syngeneic donor No active CNS leukemia

PATIENT CHARACTERISTICS: Age: Over 55 to under 75 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) ALT and AST less than 4 times ULN Renal: Creatinine clearance at least 50 mL/min Cardiovascular: Cardiac ejection fraction at least 40% No poorly controlled hypertension Pulmonary: No severe defects in pulmonary function testing No requirement for supplementary continuous oxygen

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Peter McSweeney, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Actual)

September 1, 2001

Study Completion (Actual)

September 1, 2001

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

April 9, 2004

First Posted (Estimate)

April 12, 2004

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

September 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-0119
  • UCHSC-00119
  • FHCRC-1406.00
  • NCI-G00-1778

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Clinical Trials on radiation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe