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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 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

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

~4820

Topotecan

2017

Completed Phase 3

~2400

Topotecan Hydrochloride

2013

Completed Phase 3

~6120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,856 Total Patients Enrolled

Keith W PratzPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Topotecan been tested in other research studies?

"Topotecan, discovered in 2002 at H Central de Asturias, has been investigated by 991 completed trials. Currently, 758 active studies are underway; many of these being conducted in Los Angeles and New jersey."

Answered by AI

Is it feasible to join this experiment at the present time?

"No longer admitting candidates, this clinical trial was originally posted on June 8th 2018 and last revised on July 12th 2022. If you are exploring other options, there are 1771 studies for Polycythemia vera that are currently recruiting and 758 trials involving Topotecan actively attempting to enroll patients."

Answered by AI

What is the current size of the participant pool for this research?

"As of July 12th 2022, this clinical trial has ceased to accept any more applicants. Its initial posting was on June 8th 2018 and the study had been previously updated just prior to its closure. If you are researching alternative medications for polycythemia vera or Topotecan, 1771 studies and 758 trials respectively remain open for enrollment."

Answered by AI

What therapeutic application does Topotecan typically address?

"Topotecan is often prescribed for advanced thymoma, but can also be effective when treating carcinomas, testicular cancer in its later stages, neuroendocrine malignancies and certain directives."

Answered by AI

What is the geographical scope of this clinical trial's management?

"This medical trial is available in a total of 6 different locations, ranging from Los Angeles County-USC Medical Center to Rutgers Cancer Institute of New jersey. Other sites include USC / Norris Comprehensive Cancer Center, along with 3 distinct clinical centres."

Answered by AI

What risks are associated with the use of Topotecan?

"The safety rating of topotecan is estimated to be 2, as only preliminary data indicating its security has been gathered, but no proof of efficacy exists yet."

Answered by AI

Recent research and studies

Current Hematologic Malignancy ReportsJournal

Secondary AML Emerging After Therapy with Hypomethylating Agents: Outcomes, Prognostic Factors, and Treatment Options

Richardson, Daniel R., Steven D. Green, Matthew C. Foster, and Joshua F. Zeidner. 2021. “Secondary AML Emerging After Therapy with Hypomethylating Agents: Outcomes, Prognostic Factors, and Treatment Options”. Current Hematologic Malignancy Reports. Springer Science and Business Media LLC. doi:10.1007/s11899-021-00608-6.

clinicaltrials.govStudy

Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia

2018. "Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03289910.

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