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Alkylating agents

Topotecan + Carboplatin + Veliparib for 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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With a Response

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Topotecan

2017

Completed Phase 3

~2460

Veliparib

2012

Completed Phase 3

~4780