Topotecan + Carboplatin + Veliparib for Leukemia

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byKeith W Pratz

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

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.

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

Agreement to use adequate contraception by women of child-bearing potential and men

I am mostly self-sufficient and can carry out daily activities.

I have been recently diagnosed with AML following a blood disorder.

+9 more

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 4 weeks.

I do not have any unmanaged ongoing illnesses.

Human immunodeficiency virus (HIV) patients with specific criteria

+6 more

Participant Groups

The study tests how well a combination of chemotherapy drugs (topotecan hydrochloride and carboplatin) works with or without an additional drug called veliparib in treating advanced blood cancers. It's looking at whether adding veliparib improves treatment outcomes.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (veliparib, topotecan hydrochloride, carboplatin)Experimental Treatment4 Interventions

Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (topotecan hydrochloride, carboplatin)Active Control3 Interventions

Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: