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	Treatment or Intervention	Phase
adult acute lymphoblastic leukemia in remission recurrent adult acute myeloid leukemia acute undifferentiated leukemia recurrent childhood acute myeloid leukemia recurrent adult acute lymphoblastic leukemia secondary acute myeloid leukemia recurrent childhood acute lymphoblastic leukemia childhood acute lymphoblastic leukemia in remission	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: radiation therapy  Procedure: peripheral blood stem cell transplantation  Drug: bone marrow ablation with stem cell support  Drug: cyclophosphamide  Drug: methotrexate	Phase II

Further Study Details: 

OBJECTIVES: I. Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia. II. Determine the kinetics and durability of engraftment after treatment with this regimen in these patients. III. Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen. IV. Determine the leukemia-free survival of patients treated with this regimen.

PROTOCOL 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.

Ages Eligible for Study:  up to  55 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Study chairs or principal investigators

Claudio Anasetti,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000068972; FHCRC-1099.00; NCI-H01-0078
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025545
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08