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A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT)for Primary Refractory and Relapsed Acute Myelogenous Leukemia

Phase 1
18 Years
70 Years
Open (Enrolling)
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT)for Primary Refractory and Relapsed Acute Myelogenous Leukemia

Inclusion Criteria:

1. Patients are included, if they fulfill at least one of the following criteria
defining refractory or relapsed AML according to previously established criteria 1-3:
(1) Primary induction failure (PIF) after ≥ 2 cycles of chemotherapy. (2) First
relapse. (3) Relapse refractory to salvage chemotherapy (4) Second or subsequent

2. Patients with MDS, either RAEB I or RAEB II

3. Age between 18 and 70 years old.

4. Patients must have a Karnofsky Performance Status > 70.

5. Each patient must be willing to participate as a research subject and must sign an
informed consent form.

6. If the patient has a history of a prior malignancy, they must be without any evidence
of disease of that prior malignancy for at least 2 years before being eligible for
transplant on this protocol. This excludes skin cancers that may have been excised
within that 2 year period.

7. Patients must have adequate physical function measured by:

1. Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and
must improve with exercise.

2. Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless liver is involved
with the disease or there is congenital benign hyperbilirubinemia.

3. Renal: serum creatinine within normal range for age or if serum creatinine is
outside the normal range, then CrCl > 60-ml/min.

4. Pulmonary: asymptomatic or if symptomatic, DLCO > 45% of predicted (corrected
for hemoglobin)

Exclusion Criteria:

1. Impaired renal function with a measured or calculated creatinine clearance of less
than 60 ml/min.

2. Impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of
normal or ALT or AST greater than 3 x normal.

3. Serious active or uncontrolled infection (Infections are controlled when patients are
afebrile and hemodynamically stable for 72 hours) or medical condition.

4. Women who are pregnant or breast feeding. Women of childbearing age must use adequate
contraception and have a negative pregnancy test.

5. Impaired pulmonary function with a DLCO less than 45% predicted.

6. Impaired cardiac function with an ejection fraction less than 50% of predicted by
echocardiogram or MUGA.

7. Prior daunorubicin therapy with a cumulative dose of more than 368 mg/m2 or
equivalent. The anthracycline agents commonly used in treating myeloid malignancies
are doxorubicin, idarubicin and mitoxantron.

For example, a patient who receives 7 + 3 (daunorubicin 180 mg/m2) for induction and
MEC (mitoxantrone 48 mg/m2) for salvage. The cumulative daunorubicin equivalent is
180 + (48x2) = 278 mg/m2.

8. Other systemic anticancer therapy or ongoing toxicities from such therapy.

9. Patients with a history of and/or current evidence of myocardial impairment (e.g.
cardiomyopathy, ischemic heart disease, significant valvular dysfunction,
hypertensive heart disease, congestive heart failure), resulting in heart failure by
New York Heart Association Class III or IV staging.

10. Patients with Wilson disease or other Cu-related disorders.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the toxicity and safety of the regimen

Outcome Time Frame:

cohort dependent

Safety Issue:


Principal Investigator

Usama Gergis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • AML
  • leukemia
  • MDS
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



Weill Cornell Medical College New York, New York  10021