Clinical trial · Interventional
Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)
A Pilot, Pharmacodynamic Correlate, Multi-Institutional Trial of Sirolimus in Combination With Chemotherapy (Mitoxantrone, Etoposide, Cytarabine) for the Treatment of High Risk, Acute Myelogenous Leukemia
NCT01184898CI-TRIAL-00090432completedN/AResults postedClinicalTrials.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 addition of Sirolimus (rapamycin) to standard chemotherapy for the treatment of patients with high risk acute myelogenous leukemia (AML). Cancer cells taken from the patients will be studied in the laboratory to see if rapamycin is affecting the mTOR pathway in the cells and if this effect is correlated with how well patients respond to the therapy.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sirolimus and MEC
- description
- Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
- interventionNames
- Drug: Sirolimus
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC
- timeFrame
- From pre- to post-treatment
- description
- Percent change compared between response groups (responder vs nonresponder). This outcome measure only includes patients who survived to outcome assessment.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologic evidence of high risk acute myeloid leukemia defined as one of the following: 1. Primary refractory non-M3 AML (i) Residual leukemia after a minimum of 2 prior courses of chemotherapy (Same or different) (ii) Evidence of leukemia after a nadir bone marrow biopsy demonstrates no evidence of residual leukemia. 2. Relapsed non-M3 AML 3. Any non-M3 AML age \>60 with no evidence of favorable karyotype (stratum 2 ONLY), defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBF;MYH11\] by cytogenetics, FISH, or RT-PCR 4. Secondary AML (from antecedent hematologic malignancy or following therapy with radiation or chemotherapy for another disease) with no evidence of favorable karyotype (stratum 2 ONLY), defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBF;MYH11\] by cytogenetics, FISH, or RT-PCR * Age \> or = 18 * ECOG = 0 or 1 Exclusion Criteria: * Subjects with FAB M3 (t(15;17)(q22;q21)\[PML-RAR\]) are not eligible * Subjects taking the following are not eligible: * Carbamazepine (e.g., Tegretol) * Rifabutin (e.g., Mycobutin) or * Rifampin (e.g., Rifadin) * Rifapentine (e.g., Priftin) * St. John's wort * Clarithromycin (e.g., Biaxin) * Cyclosporine (e.g. Neoral or Sandimmune) * Diltiazem (e.g., Cardizem) * Erythromycin (e.g., Akne-Mycin, Ery-Tab) * Itraconazole (e.g., Sporanox) * Ketoconazole (e.g., Nizoral) * Telithromycin (e.g., Ketek) * Verapamil (e.g., Calan SR, Isoptin, Verelan) * Voriconazole (e.g., VFEND) * Tacrolimus (e.g. Prograf) * Subjects taking fluconazole, voriconazole, itraconazole, posaconazole, and ketoconazole within 72 hours of study entry are not eligible. Reinstitution of fluconazole, voriconazole, itraconazole, posaconazole, ketoconazole and diltiazem is permissible 72 hours after the last dose of sirolimus. * Subjects must not be receiving any chemotherapy agents (except Hydroxyurea). Intrathecal methotrexate and cytarabine are permissible * Subjects must not be receiving growth factors, except for erythropoietin
References
Publications (0)
Data not yet available
No reference posted for this study.