A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT ID: NCT00861874
Last Updated: 2012-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Decitabine
20 mg/m2 IV, Days 1-5
Rapamycin
Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26
Interventions
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Decitabine
20 mg/m2 IV, Days 1-5
Rapamycin
Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
* Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of \> 40% bone marrow blasts after one cycle of chemotherapy induction OR
* Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
* Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
* ECOG performance status \<3 (Appendix 1)
Exclusion Criteria
* Abnormal liver function: Bilirubin \>2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
* Active systemic infection
* Known chronic liver disease
* Known diagnosis of human immunodeficiency virus infection (HIV)
* Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin
* Pregnant or breast feeding female subjects
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Jane Liesveld
Professor of Medicine, Hematology and Bone Marrow Transplant
Principal Investigators
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Jane Liesveld, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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References
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Liesveld JL, O'Dwyer K, Walker A, Becker MW, Ifthikharuddin JJ, Mulford D, Chen R, Bechelli J, Rosell K, Minhajuddin M, Jordan CT, Phillips GL 2nd. A phase I study of decitabine and rapamycin in relapsed/refractory AML. Leuk Res. 2013 Dec;37(12):1622-7. doi: 10.1016/j.leukres.2013.09.002. Epub 2013 Sep 8.
Other Identifiers
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26037
Identifier Type: -
Identifier Source: org_study_id