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Alkylating agent

Veliparib + Topotecan ± Carboplatin for Leukemia

Phase 1
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
Chronic myelomonocytic leukemia meeting specific criteria
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of veliparib when given with topotecan hydrochloride and carboplatin in treating patients with relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders.

Who is the study for?
This trial is for patients with certain blood cancers like acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders who have relapsed or didn't respond to previous treatments. Participants must be physically stable enough to consent and follow the protocol, not have had more than three prior chemotherapy regimens, and should not be pregnant or breastfeeding. They must use effective contraception during the study.Check my eligibility
What is being tested?
The trial is testing how well veliparib works alongside topotecan hydrochloride with or without carboplatin in treating specific blood cancers. Veliparib blocks enzymes that cancer cells need to grow while the other drugs aim to kill cancer cells by stopping their division.See study design
What are the potential side effects?
Potential side effects include reactions related to liver function (elevated AST/ALT), issues with blood clotting (disseminated intravascular coagulation), infections requiring antibiotics control, heart function impacts measured by LVEF, and general risks associated with chemotherapy such as fatigue, nausea, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic myelomonocytic leukemia.
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I can take care of myself and perform daily activities.
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I do not have an active blood clotting disorder.
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I do not have any ongoing infections that aren't under control.
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I have never had seizures.
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I have never taken ABT-888.
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I am not receiving any other cancer treatments.
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I do not have active graft-versus-host disease.
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My cancer returned after it was initially gone with treatment.
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I have been diagnosed with aggressive myeloproliferative disease or acute myeloid leukemia.
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My blood disorder is in an aggressive, high-risk stage.
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I am HIV positive but not on antiretroviral therapy.
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I do not have any other severe illnesses.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical response (CR, CRi, PR)
Maximum tolerated dose of veliparib, determined as the highest dose level where 0/3 or 1/6 experience DLT, measured according to NCI-CTCAE 4.0
Secondary outcome measures
Pharmacokinetics and pharmacodynamics of veliparib

Side effects data

From 2024 Phase 3 trial • 509 Patients • NCT02163694
87%
NEUTROPENIA
76%
THROMBOCYTOPENIA
76%
ANAEMIA
71%
NAUSEA
54%
ALOPECIA
50%
FATIGUE
46%
PERIPHERAL SENSORY NEUROPATHY
45%
DIARRHOEA
40%
LEUKOPENIA
36%
HEADACHE
34%
CONSTIPATION
34%
VOMITING
25%
ASTHENIA
24%
DECREASED APPETITE
24%
HYPOMAGNESAEMIA
21%
COUGH
20%
PAIN IN EXTREMITY
20%
DYSPNOEA
20%
DYSGEUSIA
19%
DIZZINESS
19%
OEDEMA PERIPHERAL
18%
DYSPEPSIA
18%
BACK PAIN
18%
ARTHRALGIA
18%
INSOMNIA
18%
EPISTAXIS
17%
MYALGIA
17%
DRUG HYPERSENSITIVITY
16%
ABDOMINAL PAIN UPPER
16%
PYREXIA
16%
NASOPHARYNGITIS
16%
ALANINE AMINOTRANSFERASE INCREASED
14%
ABDOMINAL PAIN
14%
UPPER RESPIRATORY TRACT INFECTION
14%
ASPARTATE AMINOTRANSFERASE INCREASED
13%
LYMPHOPENIA
13%
STOMATITIS
12%
HYPOKALAEMIA
12%
URINARY TRACT INFECTION
12%
BONE PAIN
11%
ANXIETY
11%
RASH
11%
HOT FLUSH
10%
DRY MOUTH
9%
DEPRESSION
9%
HYPOCALCAEMIA
9%
PRURITUS
9%
PARAESTHESIA
9%
MUCOSAL INFLAMMATION
8%
HYPOPHOSPHATAEMIA
8%
OROPHARYNGEAL PAIN
7%
DRY SKIN
7%
VERTIGO
7%
SINUSITIS
7%
MUSCULOSKELETAL CHEST PAIN
7%
MUSCULOSKELETAL PAIN
7%
DRY EYE
7%
INFLUENZA LIKE ILLNESS
7%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
HYPERTENSION
6%
RHINORRHOEA
6%
WEIGHT INCREASED
6%
LYMPHOEDEMA
6%
HYPERGLYCAEMIA
6%
TINNITUS
6%
PALPITATIONS
6%
TOOTHACHE
6%
NEUROPATHY PERIPHERAL
6%
DYSPNOEA EXERTIONAL
6%
PAIN
5%
HYPONATRAEMIA
5%
DEHYDRATION
5%
PRODUCTIVE COUGH
5%
GASTROOESOPHAGEAL REFLUX DISEASE
5%
ERYTHEMA
5%
MUSCLE SPASMS
5%
BREAST PAIN
5%
ABDOMINAL DISTENSION
5%
CHEST PAIN
5%
INFLUENZA
5%
RHINITIS
4%
TACHYCARDIA
4%
MALIGNANT NEOPLASM PROGRESSION
4%
RESPIRATORY TRACT INFECTION VIRAL
3%
FEBRILE NEUTROPENIA
2%
PNEUMONIA
1%
GASTRITIS
1%
APPENDICITIS
1%
SEIZURE
1%
PULMONARY EMBOLISM
1%
CHOLELITHIASIS
1%
NEUTROPENIC INFECTION
1%
SEPSIS
1%
ANAPHYLACTIC REACTION
1%
CELLULITIS
1%
DEVICE RELATED INFECTION
1%
ERYSIPELAS
1%
VASCULAR DEVICE INFECTION
1%
METASTASES TO MENINGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Veliparib Placebo With Carboplatin and Paclitaxel
Veliparib With Carboplatin and Paclitaxel

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (veliparib, topotecan hydrochloride, carboplatin)Experimental Treatment4 Interventions
Patients receive veliparib orally twice daily on days 1-8, 1-14, or 1-21 and topotecan hydrochloride with or without carboplatin IV continuously over 120 hours on days 3-7. Treatment repeats every 28-63 days for up to 6 courses 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
Topotecan Hydrochloride
2013
Completed Phase 3
~6120
Veliparib
2012
Completed Phase 3
~4820

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,263 Total Patients Enrolled
1,507 Trials studying Leukemia
379,344 Patients Enrolled for Leukemia
Keith W PratzPrincipal InvestigatorJohns Hopkins University/Sidney Kimmel Cancer Center
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Leukemia
60 Patients Enrolled for Leukemia

Media Library

Carboplatin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT00588991 — Phase 1
Leukemia Research Study Groups: Treatment (veliparib, topotecan hydrochloride, carboplatin)
Leukemia Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00588991 — Phase 1
Carboplatin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00588991 — Phase 1

Frequently Asked Questions

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

Are there any precedents of Veliparib being utilized in research?

"Veliparib was initially studied at Bristol Royal Hospital for Children in 2002 which led to the completion of 1517 clinical trials. Currently, 758 studies are actively recruiting patients and a large portion can be found in Rochester, Minnesota."

Answered by AI

Are there any potential harm associated with the use of Veliparib?

"Because it is currently a Phase 1 trial, the safety of Veliparib was assessed as 1 – meaning that there is limited data available to support its efficacy and security."

Answered by AI

What therapeutic applications is Veliparib typically utilized for?

"Veliparib is the preferred treatment for advanced thymoma and can be an effective intervention in managing various other medical conditions such as neuroendocrine carcinoma, testicular cancer, and advance directives."

Answered by AI

How many participants has this clinical trial enrolled thus far?

"This medical trial is no longer actively enrolling participants. It was first posted on November 28th 2007 and the last update occurred on June 28th 2022. If you're searching for other studies, there are 3900 trials with patients seeking treatment for polycythemia vera, as well as 758 different studies currently recruiting people who may benefit from Veliparib."

Answered by AI

Are there any available slots in this experimentation for fresh participants?

"This particular experiment is not enrolling participants at this juncture. It was initially posted on 28th November 2007 and the information was updated last on 28th June 2022. If you are in search of other trials, there are 3900 studies currently looking for polycythemia vera patients and 758 research projects searching for Veliparib volunteers."

Answered by AI
~1 spots leftby Mar 2025