Back to resultsA Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Decitabine
Rapamycin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00861874
First Posted
March 12, 2009
Last Updated
October 8, 2012
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT00861874
Brief Title
A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title
A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
20 mg/m2 IV, Days 1-5
Intervention Type
Drug
Intervention Name(s)
Rapamycin
Intervention Description
Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26
Primary Outcome Measure Information:
Title
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Liesveld, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24138944
Citation
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.
Results Reference
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A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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