Clinical Trial: Peripheral Stem Cell Transplantation With Donor White Blood Cells in Treating Older Patients With Hematologic Cancers

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center
Information provided by: National Cancer Institute (NCI)

Purpose

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

PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation with donor white blood cells in treating older patients with hematologic cancers.

Condition Treatment or Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma
 Drug: cyclosporine
 Drug: filgrastim
 Drug: mycophenolate mofetil
Phase I

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Mixed Hematopoietic Chimerism Induction Followed by Donor Lymphocyte Infusions in Older Patients with B-Cell or Other Hematologic Malignancies

Further Study Details: 

Study start: September 1997

OBJECTIVES: I. Determine whether mixed hematopoietic chimerism can be safely established using a nonmyeloablative conditioning regimen in patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or multiple myeloma.

II. Determine whether mixed chimerism can be safely converted to full donor hematopoietic chimerism by infusions of donor lymphocytes.

PROTOCOL OUTLINE: Patients with advanced malignancies receive cytoreduction per FHCRC-506 to reduce tumor bulk. Patients may also receive radiation to high risk bulky disease or skeleton lesions before transplantation.

Donors receive subcutaneous filgrastim (G-CSF) on days -4 to 0. Peripheral blood stem cells (PBSC) are collected on days -1 and 0.

Patients receive cyclosporine IV on days -1 and 0, then orally on days 1-35. On day 0, patients undergo total body irradiation, then receive unmodified G-CSF mobilized PBSC by infusion. Mycophenolate mofetil is administered beginning after the PBSC infusion and continuing until day 27.

Patients are evaluated for lymphoid and myeloid chimerism on days 28 and 56. Patients with mixed chimerism on day 56, and with no evidence of graft-versus-host disease (GVHD) receive the first infusion of donor lymphocytes (DLI) on day 65. Up to 3 more infusions may be administered, if there is evidence of increasing or persistent cancer, provided no active GVHD or low blood counts are present.

Donors undergo leukopheresis and collection of nonmobilized peripheral bone marrow cells (PBMC) on the day of the first DLI. The unirradiated donor PBMC are administered to the patient by IV infusion over 30 minutes.

Patients are followed weekly until day 90 after the last DLI, then at 4 and 6 months, then every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 20 patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or multiple myeloma will be accrued for this study in 2 years. A maximum of 10 patients with other hematologic malignancies will also be accrued.

Eligibility

Ages Eligible for Study:  50 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

--Prior/Concurrent Therapy--

  • See Disease Characteristics

--Patient Characteristics--

  • Age: 50 to 75
  • Performance status: Karnofsky 50-100% (>70% if older than 65)
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); SGOT and SGPT less than 4 times ULN
  • Renal: Creatinine clearance at least 50 mL/min
  • Cardiovascular: No cardiac failure requiring therapy; Cardiac ejection fraction at least 40%; No poorly controlled hypertension
  • Pulmonary: No severe defects in pulmonary function testing; No supplementary continuous oxygen
  • Other: Not pregnant; Fertile patients must use adequate contraception during and for 12 months after therapy
  • Donor Characteristics: 12 to 75 years; HLA genotypically identical sibling; Not identical twin; Adequate veins for leukopheresis or agree to central venous catheter; Not pregnant; HIV negative; No allergy to filgrastim (G-CSF); No current serious systemic illness

Location Information


Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States

Study chairs or principal investigators

David G. Maloney,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066032; FHCRC-1225.00; NCI-G98-1374
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003196
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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