Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission

• Register: ClinicalTrials.gov
• Last refreshed on: 11 February 2013
• Main ID: NCT00045435
• Date of registration: 06/09/2002
• Primary sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
• Public title: Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission
• Scientific title: Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission
• Date of first enrolment: April 2002
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00045435
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Brenda Sandmaier
• Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with de novo AML (French-American-British [FAB] MO-M2, M4-M7) or secondary
AML who achieve CR1 after induction chemotherapy and one or two cycles of
consolidation chemotherapy

- Transplant conditioning must occur within 6 months of diagnosis

- Patient enrollment must be approved by the Fred Hutchinson Cancer Research Center
(FHCRC) principal investigator (PI) or the PI's designee

- DONOR: Related donor who is genotypically or phenotypically identical

- DONOR: Age >= 12 years

- DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis

- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
central venous catheter (femoral, subclavian)

Exclusion Criteria:

- AML FAB M3

- AML involvement of the central nervous system (CNS) as defined by a positive cytospin
of cerebral spinal fluid at the time of enrollment

- Presence of circulating leukemic blasts (in the peripheral blood) detected by
standard pathology

- Human immunodeficiency virus (HIV) seropositivity

- Fungal infections with radiographic progression after receipt of amphotericin B or
active triazole for greater than one month

- Diffusion capacity of carbon monoxide (DLCO) corrected < 40%

- Total lung capacity (TLC) < 40%

- Forced expiratory volume in one second (FEV1) < 40% or requiring supplementary oxygen

- The FHCRC principal investigator of the study must approve enrollment of all patients
with pulmonary nodules

- Cardiac ejection fraction < 40%

- Patients with clinical or laboratory evidence of liver disease would be evaluated for
the cause of liver disease, its clinical severity in terms of liver function,
bridging fibrosis, and the degree of portal hypertension; patients will be excluded
if they are found to have fulminant liver failure, cirrhosis of the liver with
evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history
of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic
synthetic dysfunction evinced by prolongation of the prothrombin time, ascites
related to portal hypertension, bacterial or fungal liver abscess, biliary
obstruction, chronic viral hepatitis with total serum bilirubin > 3mg/dL, or
symptomatic biliary disease

- Karnofsky Performance Score < 70

- Fertile men or women unwilling to use contraceptive techniques during and for 12
months following treatment

- Females who are pregnant or breastfeeding

- No intensive chemotherapy can be given within three weeks (or the interval in which a
cycle of standard chemotherapy would be administered in a non-transplant setting)
prior to initiating the nonmyeloablative transplant conditioning

- Patients with active non-hematologic malignancies (except non-melanoma skin cancers)

- Patients with a history of non-hematologic malignancies (except non-melanoma skin
cancers) currently in a complete remission, who are less than 5 years from the time
of complete remission, and have a > 20% risk of disease recurrence

- Patients with active bacterial or fungal infections unresponsive to medical therapy

- DONOR: Identical twin

- DONOR: Pregnancy

- DONOR: HIV seropositivity

- DONOR: Inability to achieve adequate venous access

- DONOR: Known allergy to G-CSF

- DONOR: Current serious systemic illness



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome

Adult Acute Megakaryoblastic Leukemia (M7)

Adult Acute Minimally Differentiated Myeloid Leukemia (M0)

Adult Acute Monoblastic Leukemia (M5a)

Adult Acute Monocytic Leukemia (M5b)

Adult Acute Myeloblastic Leukemia With Maturation (M2)

Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Adult Acute Myeloid Leukemia in Remission

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Adult Acute Myeloid Leukemia With Del(5q)

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)

Adult Acute Myelomonocytic Leukemia (M4)

Adult Erythroleukemia (M6a)

Adult Pure Erythroid Leukemia (M6b)

Secondary Acute Myeloid Leukemia

Intervention(s)

Drug: cyclosporine

Drug: fludarabine phosphate

Drug: mycophenolate mofetil

Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation

Procedure: peripheral blood stem cell transplantation

Radiation: total-body irradiation

Primary Outcome(s)

Disease-free survival-incidence of survival without relapse [Time Frame: By 1 year after transplant]

Nonrelapse mortality (NRM)-incidence of nonrelapse death [Time Frame: By day 200 after transplant]

NRM-incidence of nonrelapse death [Time Frame: By 1 year after transplant]

Secondary Outcome(s)

Incidence of acute and chronic graft-vs-host disease (GVHD) [Time Frame: Day 80 (patients who taper off CSP by day 56)]

Incidence of acute and chronic GVHD [Time Frame: Day 100 (patients who taper off CSP by day 77)]

Incidence of rejection [Time Frame: By 1 year after transplant]

Incidence of relapse [Time Frame: By 1 year after transplant]

Overall survival [Time Frame: By 1 year after transplant]

Secondary ID(s)

1654.00

NCI-2011-01307

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)