Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia
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Purpose
RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia.
PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cyclophosphamide Drug: methotrexate Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor |
| Study Start Date: | March 1996 |
| Study Completion Date: | October 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia.
- Determine the kinetics and durability of engraftment after treatment with this regimen in these patients.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the leukemia-free survival of patients treated with this regimen.
OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then undergo leukapheresis on days -1 and 0.
Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic peripheral blood stem cells on day 0.
PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | up to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
- Primary acute leukemia beyond first remission
- High-risk acute myelogenous leukemia
- Acute lymphoblastic leukemia in first remission
Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles
- No HLA-matched identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype
- No leukoencephalopathy
PATIENT CHARACTERISTICS:
Age:
- 55 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- SGOT no greater than 2 times normal
- Hepatitis B surface antigen negative
- No prior hepatitis C
Renal:
- No impaired renal function
- Creatinine less than 2 times normal
Cardiovascular:
- No symptomatic cardiac disease
Pulmonary:
- No active pulmonary disease
- DLCO at least 60% predicted
Other:
- HIV negative
- No disease or other malignancy that severely limits life expectancy
- No severe or life-threatening infection within the past 2 weeks
- No history of septate fungal infection or disseminated candidiasis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow or peripheral blood stem cell transplantation
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy greater than 3,000 cGy to whole brain
- No prior radiotherapy of 1,500 cGy to chest or abdomen
- At least 6 months since prior involved-field radiotherapy to chest or abdomen
Surgery:
- Not specified
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Claudio Anasetti, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00025545 History of Changes |
| Other Study ID Numbers: | 1099.00, FHCRC-1099.00, NCI-H01-0078, CDR0000068972 |
| Study First Received: | October 11, 2001 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia |
adult acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia in remission acute undifferentiated leukemia secondary acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms Cyclophosphamide Methotrexate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013