Peripheral Stem Cell Transplantation With Donor White Blood Cells in Treating Older Patients With Hematologic Cancers - Article
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.
|Condition||Treatment or Intervention||Phase|
| Drug: cyclosporine |
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
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.
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.
Ages Eligible for Study: 50 Years - 75 Years
PROTOCOL ENTRY CRITERIA:
- Age 50 to 75 years: Not eligible for autologous transplantation OR Failed prior autologous transplantation; Non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL); Failed prior therapy with alkylating agent and/or fludarabine; Multiple myeloma; Stage II or III disease; Received prior chemotherapy
- Under 50 years considered on case by case basis: NHL, CLL, or multiple myeloma at high risk of regimen related toxicity
- Under 75 years with other hematologic malignancies: Treatable by allogeneic bone marrow transplant; High risk for regimen related toxicity using standard dose regimens; Autografting contraindicated; Myelodysplastic syndromes; Myeloproliferative syndromes; Acute leukemia in remission; Chronic myelogenous leukemia in second chronic phase; Hodgkin's disease
- No rapidly progressive, high grade NHL
- HLA genotypically identical sibling donor
- No CNS involvement
[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.]
- See Disease 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
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States
David G. Maloney, Study Chair, Fred Hutchinson Cancer Research Center
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
Cache Date: April 9, 2005