Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Michigan Rogel Cancer Center
With
Genzyme, a Sanofi Company
Otsuka Pharmaceutical Development & Commercialization, Inc.
Age
2–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 protocol.
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
You may not be if
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
