A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Decitabine; Drug: Rapamycin

• Registration Number: NCT00861874
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Study Start: 2010-01
• Primary Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-08
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Age greater than or equal to 18 years
• 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 renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Decitabine	-
Treatment	Rapamycin	-

Primary Outcome Measures

Name	Time	Method
Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.	6 months

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States