Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia</p>

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: cyclophosphamide
* Drug: methotrexate
* Procedure: peripheral blood stem cell transplantation
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Drug: methotrexate|nan|
|Procedure: peripheral blood stem cell transplantation|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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