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Phase II Study of Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation in Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Peripheral Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

55 and over

NCI

FHCRC-1654.00
5377, NCT00045435

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.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Primary Outcome(s)

Disease-free survival 1 year post-transplant
Nonrelapse mortality on day 200 post-transplant

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Brenda Sandmaier, MD, Protocol chair
Ph: 206-667-4961
Email: bsandmai@fhcrc.org

Registry Information

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

Trial Start Date		2002-04-04

Trial Completion Date		2008-08-13 (estimated)

Registered in ClinicalTrials.gov		NCT00045435

Date Submitted to PDQ		2002-06-26

Information Last Verified		2008-10-21

NCI Grant/Contract Number		CA78902, CA15704, CA09515

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.