10147 A Phase II randomized study of topotecan/carboplatin with or without veliparib in advanced myeloproliferative disorders and chronic myelomonocytic leukemia
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to compare any good and bad effects of adding the investigational drug, veliparib, to topotecan and carboplatin chemotherapy.
Patients with advanced myeloproliferative disorder or CMML may be eligible to participate.
This study has two study groups: Group 1 will get the topotecan (1.2mg/m2/day)/carboplatin chemotherapy given with the study drug veliparib. Group 2 will get topotecan(1.6mg/m2/day)/carboplatin chemotherapy. The topotecan/carboplatin chemotherapy are given by vein (IV infusion) on days 3-7 in Group 1 and days 1-5 in Group 2. The veliparib capsules are taken twice daily on days 1-21 and must be swallowed whole. Do not break or chew the capsules. A computer will by chance assign you to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. In this study 2 of every 3 participants will be assigned by chance to Group 1. You and your study doctor will be aware of the group the computer assigns you to.You will receive the study protocol for 21 days in the hospital. After you finish, your doctor will continue to watch you for side effects and follow your condition for recovery of normal blood counts over the course of the next several weeks. When your blood counts recover, a repeat bone marrow test will be done to assess the tumor response to the study combination. One cycle of this therapy is 28 days total with a maximum of 21 days (Group 1) or 5 days (Group 2) of study drugs. If you have responded to the study combination, you are able to receive up to three additional course of the sudy combination with the next cyle starting anytime between days 28 to 63. Another option is that you may proceed to allogeneic transplantation.
03/05/2019 05:03 AM