Peripheral Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045435

Purpose

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating older patients with acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Fludarabine Fludarabine monophosphate Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantaion From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival 1 year post-transplant [ Designated as safety issue: No ]
Nonrelapse mortality on day 200 post-transplant [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	April 2002
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine whether a 1-year disease-free survival of at least 35% can be achieved among older patients with de novo or secondary acute myeloid leukemia in first complete remission treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation.
Determine whether a day 200 nonrelapse-related mortality of less than 15% can be achieved among patients treated with this regimen.

Secondary

Determine the 1-year overall survival, incidence of relapse, and incidence of graft rejection in patients treated with this regimen.
Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell infusion on day 0. Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper on days 57-77 and oral mycophenolate mofetil twice daily on days 0-27.

After completion of study therapy, patients are followed at approximately 1, 4, 10, and 16 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of de novo acute myeloid leukemia (AML) (FAB M0-M2, M4-M7) OR secondary AML in first complete remission after prior induction chemotherapy and 1 or 2 courses of prior consolidation chemotherapy
Transplantation conditioning must occur within 6 months of diagnosis
No circulating leukemic blasts in peripheral blood confirmed by standard pathology
No involvement of CNS by positive cytospin of cerebrospinal fluid
Availability of a related donor who is genotypically or phenotypically identical
- No identical twins

PATIENT CHARACTERISTICS:

Age

55 and over

Performance status

Karnofsky 70-100%

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

No fulminant liver failure
No alcoholic hepatitis
No hepatic encephalopathy
No uncorrectable hepatic synthetic dysfunction evidenced by prolongation of PT
No ascites related to portal hypertension
No cirrhosis with evidence of portal hypertension
No bacterial or fungal liver abscess
No chronic viral hepatitis
No biliary obstruction
No symptomatic biliary disease
Bilirubin ≤ 3 mg/dL

Renal

Not specified

Cardiovascular

Cardiac ejection fraction at least 40%

Pulmonary

DLCO corrected at least 40%
No requirement for supplemental oxygen
Pulmonary nodules allowed if approved by the principal investigator

Other

HIV negative
No fungal infections with radiographic progression after treatment with amphotericin B or active triazole for more than 1 month
No esophageal varices
No history of bleeding esophageal varices
Not pregnant or nursing
Fertile patients must use effective contraception during and for 1 year after study participation
No active or history of non-hematologic malignancies except nonmelanoma skin cancer unless in complete remission within the past 5 years and at ≤ 20% risk for recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent growth factors on days 0-27 of study therapy

Chemotherapy

See Disease Characteristics
More than 3 weeks since chemotherapy and prior to nonmyeloablative transplant conditioning

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045435

Locations

United States, Oregon
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Brenda Sandmaier, MD

Fred Hutchinson Cancer Research Center

More Information

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

Responsible Party:	Fred Hutchinson Cancer Research Center ( Brenda Sandmaier )
Study ID Numbers:	CDR0000256466, FHCRC-1654.00
Study First Received:	September 6, 2002
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00045435
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
secondary acute myeloid leukemia

adult acute myeloid leukemia in remission
adult acute monocytic leukemia (M5b)
adult acute monoblastic leukemia (M5a)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Cyclosporine
Clotrimazole
Miconazole
Tioconazole
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Fludarabine monophosphate
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Cyclosporins

Leukemia, Myelomonocytic, Acute
Leukemia
Leukemia, Erythroblastic, Acute
Mycophenolate mofetil
Neoplasm Metastasis
Acute erythroblastic leukemia
Fludarabine
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute monoblastic leukemia
Acute myelocytic leukemia

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009