Clinical trial · Interventional
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias
A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias
NCT00780104CI-TRIAL-00039469UPCC 02407completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| CML | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myeloid Leukemias | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rapamycin + MEC | Drug | — | UNRESOLVED |
| Rapamycin, Mitoxantrone, Etoposide, Cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rapamycin + MEC
- interventionNames
- Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine
- Drug: Rapamycin + MEC
Primary outcomes (1)
- measure
- Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells
- timeFrame
- Study conclusion
Secondary outcomes (1)
- measure
- Safety of the sirolimus + MEC regimen
- timeFrame
- Study conclusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are \>= 60 years old * \>= 18 years of age * ECOG performance status of 0, 1 * Able to consume oral medication * Initial laboratory values: creatinine \<= 2.0 mg/dL; total or direct bilirubin \<= 1.5/dL; SGPT(ALT) \<= 3xULN; negative pregnancy test for women with child-bearing potential * Ejection fraction of \>= 45% Exclusion Criteria: * Subjects with FAM B3 * Must not be receiving chemotherapy (except Hydroxyurea) * Not receiving growth factors, except for erythropoietin * Subjects with a "currently active" second malignancy other than non-melanoma skin cancers * Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia * Subjects taking diltiazem * Subjects who require HIV protease inhibitors or those with AIDS-related illnesses * No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy * Not pregnant or breastfeeding * Uncontrolled infection * Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus
References
Publications (0)
Data not yet available
No reference posted for this study.