N/A
Completed N=36
Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)
Source: ClinicalTrials.gov NCT01184898 ↗Enrolled (actual)
36
Serious AEs
22.2%
Results posted
Aug 2014
Primary outcomePrimary: 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 — 69; -36 percentage change in leukemic blasts
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
69; -36 | — |
| SECONDARY Complete Response |
11 | — |
| SECONDARY Complete Response in the Absence of Platelet Recovery |
2 | — |
| SECONDARY Partial Response |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologic evidence of high risk acute myeloid leukemia defined as one of the following:
- 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.
- Relapsed non-M3 AML
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01184898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.