Topotecan + Carboplatin + Veliparib for Leukemia
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you must stop any chemotherapy or radiotherapy at least 4 weeks before starting, except for hydroxyurea. You can continue tyrosine kinase inhibitors until 24 hours before the trial starts.
What data supports the effectiveness of the drug combination Topotecan, Carboplatin, and Veliparib for treating leukemia?
Research shows that the combination of Topotecan, Carboplatin, and Veliparib has a 33% response rate in patients with certain blood cancers, with a higher response rate of 64% in patients with specific aggressive conditions. This suggests potential effectiveness, especially in patients with aggressive myeloproliferative neoplasms or related leukemias.12345
Is the combination of Topotecan, Carboplatin, and Veliparib safe for humans?
The combination of Topotecan, Carboplatin, and Veliparib has been studied in patients with leukemia and other blood cancers. The main safety concern is mucositis (painful inflammation and ulceration of the mucous membranes lining the digestive tract), which was dose-limiting. Hematologic toxicity (blood-related side effects) such as neutropenia (low white blood cell count) and thrombocytopenia (low platelet count) were also observed, but these side effects can be managed with dose adjustments.12346
What makes the drug combination of Topotecan, Carboplatin, and Veliparib unique for treating leukemia?
This drug combination is unique because it includes Veliparib, a PARP inhibitor that enhances the effectiveness of chemotherapy by delaying DNA repair, making cancer cells more susceptible to treatment. This approach is particularly promising for patients with aggressive forms of leukemia and those with specific DNA repair defects, offering a novel mechanism compared to standard treatments.12356
What is the purpose of this trial?
This phase II trial studies how well topotecan hydrochloride and carboplatin with or without veliparib work in treating patients with myeloproliferative disorders that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced), and acute myeloid leukemia or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as topotecan hydrochloride and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving topotecan hydrochloride, carboplatin, and veliparib may work better in treating patients with myeloproliferative disorders and acute myeloid leukemia or chronic myelomonocytic leukemia compared to topotecan hydrochloride and carboplatin alone.
Research Team
Keith W Pratz
Principal Investigator
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Eligibility Criteria
This trial is for adults with advanced myeloproliferative disorders or certain types of leukemia (AML, CMML) who haven't had more than two prior chemo treatments. They should be in decent physical shape and have normal organ function. Pregnant women can't join, and participants must agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive topotecan hydrochloride and carboplatin with or without veliparib for up to 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Topotecan
- Topotecan Hydrochloride
- Veliparib
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor