Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen

Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:2 - 65
Start Date:November 2011
End Date:March 2017

Use our guide to learn which trials are right for you!

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

Although transplant results for AML in complete remission (CR) at the time of transplant
have improved, transplant results for non-remission AML have been quite poor. Most
multi-center studies have focused on standard risk AML patients and not many studies have
been done in this population of patients with non-remission AML. There are a large number of
older patients with non-remission AML because the complete remission rate with induction
chemotherapy decreases with age. Such older patients do not tolerate conventional full
intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for
non-remission AML is a great unmet need for current transplant practice.

From the investigators earlier study, it is suggested that replacing Fludarabine of standard
FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in
the transplant conditioning regimen may potentiate the anti-tumor activity of the
conditioning regimen without adding significant toxicity, a goal of new conditioning regimen

The investigators expect to enroll a total of 75 patients from about fifteen sites. The
investigators main objective is to confirm both the safety and efficacy as measured by
one-year overall survival, of the CloBu4 combination as full intensity conditioning for
non-remission acute myelogenous leukemia.

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
We found this trial at
Nashville, Tennessee 37232
Nashville, TN
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Birmingham, AL
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Seattle, WA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Ann Arbor, MI
Click here to add this to my saved trials
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
Duarte, CA
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
Hackensack, NJ
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
Kansas City, KS
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Milwaukee, WI
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Philadelphia, PA
Click here to add this to my saved trials
St Louis, MO
Click here to add this to my saved trials