Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

October 15, 2019 updated by: University of Maryland, Baltimore

Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation from related donors to prevent graft-versus-host disease in treating patients with hematologic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Evaluate the use of donor peripheral blood stem cells without graft-versus-host disease prophylaxis to maximize the probability of graft-versus-tumor effect in patients with hematologic malignancies refractory to standard chemotherapy and unlikely to be cured with high dose chemotherapy and radiotherapy.

OUTLINE: Prior to peripheral blood stem cell transplant, patients undergo preparative cytoreduction. Patients receive total body irradiation (TBI) beginning on day -5. Radiotherapy is administered in 9 doses over 3 days (3 doses per day for 3 days). Male patients with acute lymphocytic leukemia receive an additional dose of radiation to the testicles. Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of melphalan IV on day -3. All patients receive cyclophosphamide IV over 1 hour on days -2 and -1. Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1. Approximately 24-36 hours after the last dose of cyclophosphamide, peripheral blood stem cells obtained from the HLA matched related donor are infused into the patient. Patients do not receive graft-versus-host disease prophylaxis after transplant; however, all other forms of supportive care are provided. Patients are followed for 1 year.

PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

42

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
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

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

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Patients with HLA identical family donors and any one of the following conditions documented by marrow aspiration and biopsy: -Acute leukemia refractory to induction treatment or after 1 or more relapses -Acute myeloid leukemia with t(9;22), -5/5q-, -7/7q-, and 11q23 involvement in first remission (not M4 or M5) -Acute lymphocytic leukemia with t(9;22) or t(4;11) in first remission -Myelodysplastic syndrome with greater than 5% bone marrow blasts -Chronic myeloid leukemia in accelerated phase or nonlymphoid blast crisis -Myeloma, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or Hodgkin's disease refractory to 2 lines of standard treatment or progression on standard treatment No evidence of active extramedullary disease

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL SGOT no greater than 4 times upper limit of normal and not increasing for 2-4 weeks prior to transplant Renal: Creatinine less than 2 times normal and not increasing for 2-4 weeks prior to transplant OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 50% by MUGA Pulmonary: DLCO greater than 50% Other: Not HIV positive Not pregnant or nursing Fertile patients must use effective contraceptive

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 Maryland, Baltimore

Collaborators

University of Maryland Greenebaum Cancer Center

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

September 1, 1998

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 2, 2004

First Posted (Estimate)

June 3, 2004

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066397
  • MSGCC-9805
  • NCI-V98-1430

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.

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