Study on Topotecan, Carboplatin, and Veliparib for Treating Advanced Blood Disorders and Leukemia

Program Overview

The purpose of this study is to find out if using a combination of chemotherapy drugs, topotecan and carboplatin, with or without veliparib, can more effectively treat advanced myeloproliferative disorders and certain types of leukemia, such as acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). These drugs work by stopping cancer cells from growing and spreading. Veliparib may help by blocking enzymes that cancer cells need to grow. The study aims to see if adding veliparib improves treatment outcomes compared to using topotecan and carboplatin alone.

Description

The study has two main parts:

• Primary Goal: To compare how well patients respond to treatment with topotecan and carboplatin, with or without veliparib. Researchers will look at how many patients achieve a complete response, meaning no signs of cancer, or a complete response with incomplete recovery.

• Secondary Goals: To compare the side effects of the two treatment options, to see how long patients live without the disease coming back, and to check for any remaining cancer cells after treatment. Researchers will also study certain biological markers to predict how well patients might respond to the treatment.

Study Design:

• Group A: Patients will take veliparib by mouth twice a day for 21 days, along with topotecan and carboplatin given through an IV over 24 hours on days 3 to 7. This cycle repeats every 28 to 63 days for up to 4 cycles, unless the disease worsens or side effects become too severe.

• Group B: Patients will receive topotecan and carboplatin through an IV over 24 hours on days 1 to 5. This cycle also repeats every 28 to 63 days for up to 4 cycles, unless the disease worsens or side effects become too severe.

After finishing the treatment, patients will be monitored for at least 30 days or longer to check their health and response to the treatment.

Eligibility Criteria

Locations