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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00861874

Enrollment

Registered

2009-03-16

Start date

2010-01-31

Completion date

Unknown

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

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.

Interventions

DRUGDecitabine

20 mg/m2 IV, Days 1-5

DRUGRapamycin

Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026