Clinical trial NCT00025545: Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia</p>
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-06-20
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Claudio Anasetti, MD
role: STUDY_CHAIR
References: