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

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00025545

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Radiation Therapy

Drug Information available for: Cyclophosphamide Methotrexate

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date:	March 1996
Study Completion Date:	October 2002
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	up to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025545

Locations

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

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Claudio Anasetti, MD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068972, FHCRC-1099.00, NCI-H01-0078
Study First Received:	October 11, 2001
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00025545 History of Changes
Health Authority:	United States: Federal Government

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

Study placed in the following topic categories:

Acute Lymphoblastic Leukemia, Childhood
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Folate
Cyclophosphamide
Leukemia, Myeloid, Acute
Vitamin B9
Leukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Neoplasm Metastasis
Methotrexate

Alkylating Agents
Acute Lymphoblastic Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Folic Acid Antagonists
Folinic Acid
Immunosuppressive Agents
Recurrence
Acute Myeloid Leukemia, Childhood
Folic Acid
Antineoplastic Agents, Alkylating
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Reproductive Control Agents
Leukemia
Therapeutic Uses
Abortifacient Agents
Methotrexate
Alkylating Agents

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 02, 2009