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Multi-center Single Arm Phase II Study of Myeloablative Allogeneic Stem Cell Transplantation for Non-remission Acute Myeloblastic Leukemia (AML) Using Clofarabine and Busulfan x 4 (CloBu4) Regimen

Phase 2
2 Years
65 Years
Open (Enrolling)
Acute Myeloblastic Leukemia

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Trial Information

Multi-center Single Arm Phase II Study of Myeloablative Allogeneic Stem Cell Transplantation for Non-remission Acute Myeloblastic Leukemia (AML) Using Clofarabine and Busulfan x 4 (CloBu4) Regimen

Inclusion Criteria:

Disease Criteria

- AML not in remission at the time of transplant

- "Not in remission" is defined as "greater than 5.0% bone marrow blasts by
aspirate morphology," as determined by a bone marrow aspirate obtained within 2
weeks of study registration.

- For primary induction failure patients: Patients must have failed at least 2
induction regimens.

- For patients with relapsed disease: Patients who relapse more than 6 months
after preceding remission must fail at least one reinduction regimen to be
eligible. For patients in whom the preceding remission is equal to or shorter
than 6 months duration, no re-induction regimen is required to qualify for this

- If the pre-transplant bone marrow aspirate and biopsy are hypoplastic (less than 10%
cellularity), and blast percentages cannot be determined, the patient is eligible if
the preceding bone marrow met the above criteria.

- Patients with peripheral circulating blasts or patients with extramedullary leukemia
are eligible if bone marrow aspirate and biopsy meets the above criteria. Age and
Organ Function Criteria

- Age: 2 to 65 years in age.

- Cardiac: LVEF ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.

- Pulmonary: FEV1 and FVC capacity) ≥ 40% predicted, DLCO (corrected for hemoglobin) ≥
40% of predicted.

- Children who are unable to cooperate for pulmonary function tests (PFTs), must have
no evidence of dyspnea at rest, no exercise intolerance, and not require supplemental
oxygen therapy.

- Renal: Age equal to or older than 12: The estimated creatinine clearance (CrCl) must
be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault
Formula. Age younger than 12: Either estimated or measured CrCl should be greater
than 90 ml/min/1.73m2. For estimation, Schwartz formula will be used.

- Hepatic: Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); (AST)/ ALT ≤ 2.5 x
ULN; Alkaline phosphatase ≤ 2.5 x ULN

- Performance status: Karnofsky ≥ 70%., or Lansky≥70% Consent: All patients must sign
informed consent

Exclusion Criteria:

- Active life-threatening cancer requiring treatment other than AML

- Non-compliant to medications.

- No appropriate caregivers identified.

- HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive

- Active life-threatening cancer requiring treatment other than AML

- Uncontrolled medical or psychiatric disorders.

- Uncontrolled infections, defined as positive blood cultures within 72 hours of study
entry, or evidence of progressive infection

- Active central nervous system (CNS) leukemia

- Preceding allogeneic HSCT

- Receiving intensive chemotherapy within 21 days of registration.

- Patients with preceding primary myelofibrosis

- Peripheral blasts > 10,000/μL at the time of registration

Type of Study:


Study Design:

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

Outcome Measure:

Disease free survival following transplant using a CloBu4 conditioning regimen for patients with non-remission AML

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Shin Mineishi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:

UMCC 2011.038



Start Date:

November 2011

Completion Date:

March 2017

Related Keywords:

  • Acute Myeloblastic Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Medical College of Wisconsin Milwaukee, Wisconsin  53226
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Hackensack University Medical Center Hackensack, New Jersey  07601
City of Hope National Medical Center Los Angeles, California  91010
University of Washington Seattle, Washington  98195
University of Pennsylvania Philadelphia, Pennsylvania  19104
University of Michigan Cancer Center Ann Arbor, Michigan  48109
University of Alabama, Birmingham Birmingham, Alabama  35233
Washington University at St Louis St Louis, Missouri  63110
Vanderbuilt University Nashville, Tennessee  37232