Table 1.
Ongoing Clinical Trials
| Disease | Phase | Location(s) | Clinical Trials.gov number | Additional Information |
|---|---|---|---|---|
| ALL | II | COG Transplant Centers | NCT00795886 | Randomized trial comparing sirolimus plus standard GVHD ppx vs standard GVHD ppx alone after stem cell transplant for ALL* |
| ALL/NHL | I | Philadelphia, PA | NCT00068302 | Sirolimus for relapsed/refractory ALL or NHL |
| ALL/NHL CML** | I/II | Philadelphia, PA | NCT00776373 | Sirolimus plus etoposide and cytarabine for relapsed/refractory lymphoid malignancies |
| AML | I/II | Philadelphia, PA | NCT00780104 | Sirolimus plus MEC chemotherapy for high risk AML |
| AML | I | Melbourne, Australia | NCT00636922 | Everolimus plus cytarabine in elderly with AML |
| AML | I | Paris, France | NCT00544999 | Everolimus plus cytarabine and daunorubicin in relapsed AML |
| AML | II | Rome, Italy | NCT00775593 | Temsirolimus and clofarabine for relapsed or refractory AML |
| AML | I/II | Bavaria, Germany | NCT00762632 | Everolimus plus nilotinib for c-kit+ CML |
| CLL/B-NHL | II | Houston, TX | NCT00290472 | Temsirolimus for relapsed/refractory CLL or B cell NHL |
| CML** | I | Multiple centers in U.S, China, and Singapore | NCT00101088 | Temsirolimus and imatinib for CML accelerated phase |
| NHL | I | Ontario, Canada | NCT00659568 | Temsirolimus for advanced lymphoma |
| NHL | I | Cleveland, OH | NCT00671112 | Everolimus plus bortezomib for relapsed refractory MCL and other NHL |
| NHL | II | Multiple centers U.S. | NCT00436618 | Everolimus for refractory or advanced NHL |
| NHL | I | Tokyo, Japan | NCT00622258 | Everolimus for refractory or relapsed NHL |
| NHL/HD | I/II | Multiple centers U.S. | NCT00704054 | Deforolimus for relapsed/refractory NHL HD |
| MCL | II | Munich, Germany | NCT00727207 | Everolimus for relapsed/refractory MCL |
| NHL/HD MM | I/II | Multiple centers U.S. | NCT00474929 | Everolimus and Sorafenib for relapsed or refractory NHL, HD, or MM |
| MM | I | New York, NY | NCT00317798 | Sirolimus and ATG for relapsed MM |
| MM | I | Multiple centers U.S. | NCT00729638 | Everolimus and lenalidomide for relapsed MM |
| Advanced malignancies | I | Houston, TX | NCT00678233 | Temsirolimus plus IMC-A12 (anti-IGF-1R ab) for locally advanced or metastatic malignancy, including hematologic |
| Advanced malignancies | I | San Antonio, TX | NCT00060645 | Deforolimis for relapsed/refractory malignancies, including NHL, HD, and MM |
*
A number of clinical trials are on-going using sirolimus post-stem cell transplant as part of GVHD prophylaxis in patients with hematologic maligancies. ASCT0431 is the only one that randomizes patients to sirolimus versus no sirolimus with the hypothesis that sirolimus will improve survival via a direct action of sirolimus on ALL blasts.
**
CML in late accelerated phase or blast crisis
AML = acute myelogenous leukemia; ALL = acute lymphoblastic leukemia; CLL = chronic lymphocytic leukemia; CML = chronic myelogenous leukemia; NHL = Non-hodgkins lymphoma; HD = hodgkins disease; MM = multiple myeloma; GVHD = graft vs host disease; ppx = prophylaxis; MEC = mitoxantrone, cytarabine, etoposide