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

Acute Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00623935
• Other study ID #: UMCC 2006.065
• Secondary ID: HUM00006772
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 14, 2008
• Last updated: June 12, 2015
• Start date: March 2007
• Est. completion date: January 2016

Study information

• Verified date: June 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: January 2016
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Fludarabine
Fludarabine (40 mg/m2/day x 4 days)
• Busulfan
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).

Radiation:
• 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.

Procedure:
• Stem Cell Transplant
Allogeneic stem cell transplant from related or unrelated donor

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Relapse Free Survival at 1 Year	The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.	1 year	No
Secondary	Percentage of Participants Alive at 1 Year	One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor.	1 year	Yes