Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia

NCT ID: NCT00623935

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2015-11-30

Brief Summary

The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals > 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.

Conditions

Acute Myelogenous Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fludarabine plus Busulfan (CR)

Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

Fludarabine (40 mg/m2/day x 4 days)

Busulfan

Intervention Type: DRUG

Busulfan (3.2 mg/m2/day x 2 days or x 4 days).

Total Body Irradiation

Intervention Type: RADIATION

Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.

Stem Cell Transplant

Intervention Type: PROCEDURE

Allogeneic stem cell transplant from related or unrelated donor

Fludarabine plus Busulfan (PR)

Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

Fludarabine (40 mg/m2/day x 4 days)

Busulfan

Intervention Type: DRUG

Busulfan (3.2 mg/m2/day x 2 days or x 4 days).

Stem Cell Transplant

Intervention Type: PROCEDURE

Allogeneic stem cell transplant from related or unrelated donor

Interventions

Fludarabine

Fludarabine (40 mg/m2/day x 4 days)

Intervention Type: DRUG

Busulfan

Busulfan (3.2 mg/m2/day x 2 days or x 4 days).

Intervention Type: DRUG

Total Body Irradiation

Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.

Intervention Type: RADIATION

Stem Cell Transplant

Allogeneic stem cell transplant from related or unrelated donor

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

For Study Registration:

• Age 55 - 70 years.
• Subjects diagnosed with AML (> 20% myeloblasts).

For Proceeding to Transplant:

• Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
• Subjects must be > 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
• Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):

• Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
• Pulmonary: FEV1 and FVC > 40% predicted, DLCO > 40% of predicted.
• Renal: Serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH).
• Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN
• Karnofsky > 60%.
• Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):

• Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
• Pulmonary: FEV1 and FVC > 50% predicted, DLCO (corrected for hemoglobin) > 50% of predicted.
• Renal: serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH)
• Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN.
• Karnofsky > 60%.

Exclusion Criteria

For Study Registration:

• Subjects with M3 AML (FAB classification)

For Proceeding to Transplant:

• Subjects who exhibit signs of progressive disease (> 20% blasts) within 14 days prior to admission for transplant
• Patients with an uncontrolled viral or fungal infection within the prior 28 days.
• Patients who are HIV1 or HIV2 positive.
• Uncontrollable medical or psychiatric disorder

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Yanik, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Comprehesive Cancer Ctr

Locations

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00006772

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2006.065

Identifier Type: -

Identifier Source: org_study_id