Trial · NCT03289910
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
NCT03289910, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-04-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia. Trials, record NCT03289910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03289910
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
- NCT number
- NCT03289910
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Essential Thrombocythemia, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis, Polycythemia Vera, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Interventions
- Carboplatin, Topotecan, Topotecan Hydrochloride, Veliparib
- First posted
- 2017-09-21
- Last updated
- 2026-06-23
- Results first posted
- 2024-04-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response | Up to 7 months | Based on published standards for acute leukemias, Complete Response (CR) means less than 5% leukemic blasts in the bone marrow, no blasts in the blood, no longer presence of cytogenetic abnormalities, no longer presence of extramedullary disease, with or without absolute neutrophil count or platelet count recovery; Partial Remission (PR) includes the criteria for Complete Remission except there are 5-25% leukemic blasts in the bone marrow and there is absolute neutrophil count and platelet count recovery; Hematologic Improvement (HI) means the disease has not gotten worse and there is at least a 20% decrease in the leukemic blasts in the bone marrow and/or a decrease in leukemia symptoms. Response = CR, PR, or HI. |
| Secondary | The Highest Grade Adverse Event Experienced | Up to 7 months | Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Secondary | Number of Participants Without Disease at Study Completion | Up to 7 months | Study completion was either death or completion of all protocol-specified activities, whichever came first. Participants who came off study due to disease-related death were counted as having disease. |
| Secondary | Duration of Disease-free Survival | Up to 7 months | Disease-free survival is defined as participants who are still alive and without disease at study completion. Study completion was either death or completion of all protocol-specified activities, whichever came first. |
| Secondary | Number of Participants Still Alive at Study Completion | Up to 7 months | Study completion was either death or completion of all protocol-specified activities, whichever came first. |
| Secondary | Duration of Overall Survival at the Time of Study Completion | Up to 7 months | Study completion was either death or completion of all protocol-specified activities, whichever came first. Duration was measured from the date of registration to the participant's study completion date. |
| Secondary | Number of Participants With Minimal Residual Disease (MRD) After Treatment | Up to 7 months | Minimal residual disease (MRD) refers to a small number of leukemic cells that remain after treatment. |
| Secondary | Distribution of Mutations in Deoxyribonucleic Acid (DNA) Repair Defects Via Assessment in Leukemia Mutation Panel | Baseline | Will be summarized using descriptive statistics. The association response will be described with appropriate tests for continuously measured biomarkers (t tests, Wilcoxon rank sum tests) and categorical biomarkers (Fisher's exact test). Descriptive analyses will be performed for the whole cohort and also separately for Arms A and B. Differential treatment outcomes for patient subgroups may be explored using appropriate tests for interactions. |
| Secondary | Frequency of Patients With Functional Impairment of DNA Damage Response Via Assessment With RAD51 Assay | Baseline | Will be reported with exact binomial 95% confidence intervals. The association response will be described with appropriate tests for continuously measured biomarkers (t tests, Wilcoxon rank sum tests) and categorical biomarkers (Fisher's exact test). Descriptive analyses will be performed for the whole cohort and also separately for Arms A and B. Differential treatment outcomes for patient subgroups may be explored using appropriate tests for interactions. |
| Secondary | Topotecan-induced Stabilization of Topoisomerase I-DNA Covalent Complexes | Up to 7 months | Topotecan-induced stabilization of topoisomerase I-DNA covalent complexes from peripheral blood |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response | Up to 7 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Highest Grade Adverse Event Experienced | Up to 7 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Without Disease at Study Completion | Up to 7 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Disease-free Survival | Up to 7 months | days | MEDIAN | |
| SECONDARY | Number of Participants Still Alive at Study Completion | Up to 7 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Overall Survival at the Time of Study Completion | Up to 7 months | Days | MEDIAN | |
| SECONDARY | Number of Participants With Minimal Residual Disease (MRD) After Treatment | Up to 7 months | Data was not collected. | ||
| SECONDARY | Distribution of Mutations in Deoxyribonucleic Acid (DNA) Repair Defects Via Assessment in Leukemia Mutation Panel | Baseline | Data not collected. | ||
| SECONDARY | Frequency of Patients With Functional Impairment of DNA Damage Response Via Assessment With RAD51 Assay | Baseline | Data not collected. | ||
| SECONDARY | Topotecan-induced Stabilization of Topoisomerase I-DNA Covalent Complexes | Up to 7 months | Data not collected. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Response | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | Participants with a response | 5 | Participants | |
| Number of Participants With a Response | Arm B (Topotecan Hydrochloride, Carboplatin) | Participants with a response | 4 | Participants | |
| Number of Participants With a Response | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | Participants who did not have a response | 11 | Participants | |
| Number of Participants With a Response | Arm B (Topotecan Hydrochloride, Carboplatin) | Participants who did not have a response | 5 | Participants | |
| The Highest Grade Adverse Event Experienced | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | Grade 5 Adverse Events | 0 | Participants | |
| The Highest Grade Adverse Event Experienced | Arm B (Topotecan Hydrochloride, Carboplatin) | Grade 5 Adverse Events | 1 | Participants | |
| The Highest Grade Adverse Event Experienced | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | Grade 4 Adverse Events | 14 | Participants | |
| The Highest Grade Adverse Event Experienced | Arm B (Topotecan Hydrochloride, Carboplatin) | Grade 4 Adverse Events | 8 | Participants | |
| The Highest Grade Adverse Event Experienced | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | Grade 3 Adverse Events | 2 | Participants | |
| The Highest Grade Adverse Event Experienced | Arm B (Topotecan Hydrochloride, Carboplatin) | Grade 3 Adverse Events | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 16 | |
| Overall Study | STARTED | Arm B (Topotecan Hydrochloride, Carboplatin) | 9 | |
| Overall Study | COMPLETED | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 16 | |
| Overall Study | COMPLETED | Arm B (Topotecan Hydrochloride, Carboplatin) | 9 | |
| Overall Study | NOT COMPLETED | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 0 | |
| Overall Study | NOT COMPLETED | Arm B (Topotecan Hydrochloride, Carboplatin) | 0 |
Source ClinicalTrials.gov
Adverse events436
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 14 | 16 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Topotecan Hydrochloride, Carboplatin) | 9 | 9 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 11 | 16 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B (Topotecan Hydrochloride, Carboplatin) | 5 | 9 | |
| other | Hemolysis | Blood and lymphatic system disorders | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 1 | 16 | |
| other | Hemolysis | Blood and lymphatic system disorders | Arm B (Topotecan Hydrochloride, Carboplatin) | 0 | 9 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 1 | 16 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Arm B (Topotecan Hydrochloride, Carboplatin) | 1 | 9 | |
| other | Atrial fibrillation | Cardiac disorders | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 0 | 16 | |
| other | Atrial fibrillation | Cardiac disorders | Arm B (Topotecan Hydrochloride, Carboplatin) | 3 | 9 |
1 to 10 of 436Source ClinicalTrials.gov
See all 436 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 11 | 16 |
| Total, all-cause mortality | Arm B (Topotecan Hydrochloride, Carboplatin) | 4 | 9 |
| Total, other adverse events | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 16 | 16 |
| Total, other adverse events | Arm B (Topotecan Hydrochloride, Carboplatin) | 9 | 9 |
| Total, serious adverse events | Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 4 | 16 |
| Total, serious adverse events | Arm B (Topotecan Hydrochloride, Carboplatin) | 4 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33609248 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) vs Arm B (Topotecan Hydrochloride, Carboplatin): Number of Participants Still Alive at Study Completion | Trial comparisons |
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) vs Arm B (Topotecan Hydrochloride, Carboplatin): deaths from any cause | Trial comparisons |
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) vs Arm B (Topotecan Hydrochloride, Carboplatin): Number of Participants Without Disease at Study Completion | Trial comparisons |
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) vs Arm B (Topotecan Hydrochloride, Carboplatin): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03289910
GET https://conductscience.org/api/trials/v1/NCT03289910/events?page=2