Trial · NCT02484391
CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma
NCT02484391, Phase 1, Completed, Wake Forest University Health Sciences; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma. Trials, record NCT02484391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02484391
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma
- NCT number
- NCT02484391
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 48 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Granulocytic Sarcoma, Recurrent Adult Acute Myeloid Leukemia
- Interventions
- 6,8-Bis(benzylthio)octanoic Acid, Cytarabine, Hematopoietic Cell Transplantation, Mitoxantrone Hydrochloride
- First posted
- 2015-06-29
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | Up to 12 weeks of maintenance therapy | Feasibility is determined by the percentage of patients eligible for maintenance therapy who complete at least 3 cycles, if ≥50% of eligible patients complete 3 cycles of maintenance therapy we will consider this regimen feasible for future study. |
| Secondary | Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 | Up to 6 months | The frequency of toxicities experienced by the participants will be presented by type and grade in an effort to monitor and report safety of the treatment. Showing grade 2 and greater event and the highest grade of each type per participant so that a participant is only evaluated once per toxicity type. Reporting events where at least 10% (n=5) of study participants reported a grade 2 or greater event. |
| Secondary | Overall Survival | Time from enrollment on trial to death from any cause, assessed up to 30 months after completion of therapy | Will use Kaplan-Meier estimation to analyze overall survival. |
| Secondary | Response Rate (CR and CRi), Assessed by Standard Criteria for AML | Up to 3 years | Confidence intervals will be calculated around the estimates of the response rate (CR and CRi). Assuming a response rate of 0.5, with 50 participants, 95 percent confidence intervals can be created with a 0.14 margin of error (0.36, 0.64). |
| Other | Early Mortality (Death Within 60 Days of Beginning of Treatment) | Up to 60 days | Early mortality (death within 60 days of beginning of treatment). |
| Other | Complete Response | Up to 3 years | Complete response rates |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | Up to 12 weeks of maintenance therapy | None of the 9 participants in the 1500 mg arm and the 7 participants in the 2000 mg arm started maintenance, only 2 out of the 5 participants in the 2500 mg arm started maintenance. None of participants completed three cycles of maintenance. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 | Up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Time from enrollment on trial to death from any cause, assessed up to 30 months after completion of therapy | months | MEDIAN | |
| SECONDARY | Response Rate (CR and CRi), Assessed by Standard Criteria for AML | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Early Mortality (Death Within 60 Days of Beginning of Treatment) | Up to 60 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Complete Response | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1,116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | 1500 | Started maintenance therapy | 0 | Participants | |
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | 2000 | Started maintenance therapy | 0 | Participants | |
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | 2500 | Started maintenance therapy | 2 | Participants | |
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | 1500 | Completed 3 cycles of maintenance therapy | 0 | Participants | |
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | 2000 | Completed 3 cycles of maintenance therapy | 0 | Participants | |
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses | 2500 | Completed 3 cycles of maintenance therapy | 0 | Participants | |
| Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 | 1500 | Abdominal pain / Grade 2 | 3 | Participants | |
| Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 | 2000 | Abdominal pain / Grade 2 | 1 | Participants | |
| Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 | 2500 | Abdominal pain / Grade 2 | 5 | Participants | |
| Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 | 1500 | Abdominal pain / Grade 3 | 0 | Participants |
1 to 10 of 1,116Source ClinicalTrials.gov
See all 1,116 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1500 | 21 | |
| Overall Study | STARTED | 2000 | 20 | |
| Overall Study | STARTED | 2500 | 7 | |
| Overall Study | Achieved Remission | 1500 | 9 | |
| Overall Study | Achieved Remission | 2000 | 7 | |
| Overall Study | Achieved Remission | 2500 | 5 | |
| Overall Study | Received Maintenance Therapy | 1500 | 0 | |
| Overall Study | Received Maintenance Therapy | 2000 | 0 | |
| Overall Study | Received Maintenance Therapy | 2500 | 2 | |
| Overall Study | COMPLETED | 1500 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events612
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 | 1500 | 20 | 21 | 38 |
| other | Anemia | Blood and lymphatic system disorders | 2000 | 19 | 20 | 36 |
| other | Anemia | Blood and lymphatic system disorders | 2500 | 6 | 7 | 14 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | 1500 | 15 | 21 | 21 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | 2000 | 18 | 20 | 27 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | 2500 | 7 | 7 | 12 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 1500 | 6 | 21 | 8 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 2000 | 13 | 20 | 14 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 2500 | 4 | 7 | 4 |
| other | Blood and lymphatic system disorders - Other: | Blood and lymphatic system disorders | 1500 | 2 | 21 | 2 |
1 to 10 of 612Source ClinicalTrials.gov
See all 612 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1500 | 6 | 21 |
| Total, all-cause mortality | 2000 | 6 | 20 |
| Total, all-cause mortality | 2500 | 1 | 7 |
| Total, other adverse events | 1500 | 21 | 21 |
| Total, other adverse events | 2000 | 20 | 20 |
| Total, other adverse events | 2500 | 7 | 7 |
| Total, serious adverse events | 1500 | 21 | 21 |
| Total, serious adverse events | 2000 | 16 | 20 |
| Total, serious adverse events | 2500 | 4 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35354808 | 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 |
|---|---|---|---|---|---|
| P30CA012197 | Cancer Center Support Grant | MESA, RUBEN A. | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02484391
GET https://conductscience.org/api/trials/v1/NCT02484391/results?page=2