This study is searching for patients with chronic myeloid leukemia (CML) to try a new drug ruxolitinib (NSC-752295) with BCR-ABL Tyrosine Kinase Inhibitors. The main outcome that will be measured is the rate of significant reduction of the BCR-ABL marker. This trial is recruiting across the United States.
The details
BCR-ABL is a protein associated with CML. Reducing the levels of BCR-ABL within tumor cells can slow cancer progression. BCR-ABL Tyrosine Kinase Inhibitors (TKI) are anti-cancer drugs used to inhibit BCR-ABL protein. Therefore they are commonly used to treat CML. Dasatinib (Sprycel) and nilotinib (Tasigna) are such BCR-ABL TKI drugs. Ruxolitinib is a new anti-cancer drug which may be effective in combination with TKIs for CML.
This study will investigate the effects of ruxolitinib and TKIs. The main measurement will be the percentage of patients that experience a significant reduction in the levels of BCR-ABL 12 months after treatment.
Who are they looking for?
This study will enroll 84 patients. Patients must have CML with detectable BCR-ABL levels. To participate, patients must have been treated with either of the TKIs dasatinib or nilotinibfor at least 6 months. Patients must have adequate bone marrow, kidney, and liver function. Female patients must not be pregnant and must use contraception during the study.
Participants must not have been treated with more than two different TKIs, must not be on other study drugs and must not have HIV.
How will it work
Participants will be split into two groups. Those in group one will receive dasatinib once a day or nilotinib twice a day. This will continue for 90 days. Participants will receive up to 4 rounds of treatment. Treatment will stop if the cancer worsens or the participant experiences severe side-effects.
Participants in group 2 will receive ruxolitinib twice a day. They will also receive either dasatinib once daily or nilotinib twice a day. This will continue for 90 days. Participants will receive up to 4 rounds of treatment. Treatment will stop if the cancer worsens or the participant experiences severe side-effects.
Response to treatment and survival will be measured up to 5 years.
