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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861874
• Other study ID #: 26037
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2009
• Last updated: October 8, 2012
• Start date: January 2010

Study information

• Verified date: October 2012
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes