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


Phase 2
55 Years
70 Years
Open (Enrolling)
Both
Acute Myelogenous Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the 1 year relapse free survival (RFS) for individuals > 55 years in age with AML CR (or PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Gregory Yanik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Comprehesive Cancer Ctr

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2006.065

NCT ID:

NCT00623935

Start Date:

March 2007

Completion Date:

March 2015

Related Keywords:

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

Name

Location

University of Michigan Cancer CenterAnn Arbor, Michigan  48109