Evaluation of RUX and AZA Combination as a Therapy For Patients With Myelofibrosis And Myelodysplastic Syndrome/ Myeloproliferative Neoplasm | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01787487

Evaluation of RUX and AZA Combination as a Therapy For Patients With Myelofibrosis And Myelodysplastic Syndrome/ Myeloproliferative Neoplasm
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The goal of this clinical research study is to learn if the combination of ruxolitinib and azacytidine can help to control myelofibrosis and myelodysplastic syndrome/myeloproliferative neoplasm.

Ruxolitinib is designed to block a pathway that has been found to be overactive in human cancers and myelofibrosis.

Azacytidine is designed to block certain proteins in cancer cells that stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.

Status: 
Recruiting
Study Date: 
Fri, 03/01/2013 to Thu, 03/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Ruxolitinib (RUX) Four weeks (28 days) on therapy is considered one standard cycle of therapy. RUX will be given orally and AZA will be administered subcutaneously (SC) in an outpatient setting AZA will be given on days 1-5 of each 28 day cycle beginning with cycle 4. We propose to initially administer RUX alone at a dose of 5 mg orally twice daily (BID) if the baseline platelet count is 50-100 x 109/L, 15 mg twice daily if the baseline platelet count is 100 - 200 109/L, or at a dose of 20 mg twice daily if the baseline platelet count is > 200 x 109/L. Patients will receive RUX alone for cycles # 1, 2 and 3. Other Names: Jakafi INCB018424 INC424 Drug: Azacitidine (AZA) Four weeks (28 days) on therapy is considered one standard cycle of therapy. RUX will be given orally and AZA will be administered subcutaneously (SC) in an outpatient setting AZA at 25 mg/sq.m. starting on cycle # 4. If well tolerated, the AZA dose may be further increased to 50 mg/sq.m. after 2 cycles (i.e., concomitantly with cycle # 6). Other Names: 5-Azacitidine 5-aza Vidaza 5-AZC AZA-CR Ladakamycin NSC-102816 Behavioral: Questionnaires Completion of 2 questionnaires at baseline, Day 1 of Cycles 1 - 7, then every 3 cycles. It should take about 15 minutes total to complete the questionnaires. Other Name: Surveys