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Alkylating agents

Veliparib for Chronic Myelomonocytic Leukemia

Phase 2
Waitlist Available
Led By Keith W Pratz
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Awards & highlights

Study Summary

This trial is testing how well topotecan hydrochloride, carboplatin, and veliparib work in treating patients with myeloproliferative disorders and acute myeloid leukemia or chronic myelomonocytic leukemia.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk, hair loss, nerve damage causing numbness or tingling sensations, allergic reactions to the drugs used, and potential harm to unborn babies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With a Response
Secondary outcome measures
Distribution of Mutations in Deoxyribonucleic Acid (DNA) Repair Defects Via Assessment in Leukemia Mutation Panel
Duration of Disease-free Survival
Duration of Overall Survival at the Time of Study Completion
+7 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Veliparib
2012
Completed Phase 3
~4800
Topotecan
2017
Completed Phase 3
~2400
Topotecan Hydrochloride
2013
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,289 Total Patients Enrolled
Keith W PratzPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
1 Previous Clinical Trials
12 Total Patients Enrolled
~4 spots leftby Jun 2025
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