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NCT Number: NCT00623935

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

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.

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Key information

Conditions

Acute Myelogenous Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Drug

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

busulfan

Drug

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

Total Body Irradiation

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

Procedure

Allogeneic stem cell transplant from related or unrelated donor

Primary outcomes

  1. Percentage of Participants With Relapse Free Survival at 1 Year

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants Alive at 1 Year

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2015
First posted
Feb 26, 2008
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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