Trial · NCT02520011
Alvocidib Biomarker-driven Phase 2 AML Study
NCT02520011, Phase 2, Terminated, Sumitomo Pharma America, Inc.; results first posted 2021-07-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alvocidib Biomarker-driven Phase 2 AML Study. Trials, record NCT02520011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02520011
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alvocidib Biomarker-driven Phase 2 AML Study
- NCT number
- NCT02520011
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Alvocidib, Cytarabine, Mitoxantrone
- First posted
- 2015-08-11
- Last updated
- 2023-11-15
- Results first posted
- 2021-07-15
- Limitations and caveats
The protocol underwent a few major amendments to shorten time to complete and allow for an expeditious analysis and reporting of outcomes. The study was terminated early Jan 2020 due to marked decrease in enrollment and thus could not reach all of its efficacy endpoints. Only select analyses could be performed. Treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received ACM or CM regimen and their disease stages at study entry.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Best response after at least 1 cycle through study completion approximately 4 years | Complete Remission (CR) rate = Percentage of patients achieving CR after Cycle 1 as defined in Stage 1 by the International Working Group (IWG) Criteria and 2010 European LeukemiaNet (EN) criteria in patients with relapsed or refractory AML with MCL-1 dependence \>30% and in Stage 2 by the 2017 ELN criteria. The study was terminated in January 2020 due to a steady and marked reduction in enrollment. Thus, the efficacy endpoints could not be analyzed. As sufficient efficacy results were not available to analyze patients based on the percentage of MCL-1 dependency the treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received the ACM vs CM regimen and their disease stages at study entry. |
| Other | Response to Treatment | Best response after at least 1 cycle through study completion approximately 4 years | To determine if treatment with ACM can induce CR in patients with relapsed or refractory AML with MCL-1 dependence of \>30% who failed to achieve CR following 1 cycle of CM |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Best response after at least 1 cycle through study completion approximately 4 years | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Response to Treatment | Best response after at least 1 cycle through study completion approximately 4 years | A total 11 patients were initially randomized to the CM arm. 6 had CR from receiving CM so they did not cross over to receive ACM. Of the remaining 5 patients, only 2 crossed over to receive ACM and were included in the analysis of this outcome. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stage 2 CM Relapsed/Refractory | Complete Remission (CR) | 6 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stage 2 ACM Relapsed/Refractory | Complete Remission (CR) | 2 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stage 1 ACM Relapsed/Refractory | Complete Remission (CR) | 8 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stages 1 and 2 ACM Relapsed/Refractory | Complete Remission (CR) | 21 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stage 1 Newly Diagnosed ACM | Complete Remission (CR) | 6 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | All Stages and Cohorts (Including Randomized Stage): ACM Total | Complete Remission (CR) | 27 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stage 2 CM Relapsed/Refractory | CR with Incomplete Neutrophil Recovery (Cri) | 0 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stage 2 ACM Relapsed/Refractory | CR with Incomplete Neutrophil Recovery (Cri) | 3 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stage 1 ACM Relapsed/Refractory | CR with Incomplete Neutrophil Recovery (Cri) | 5 | participants | |
| Complete Response (CR) Rate in Patients With Relapsed or Refractory AML | Stages 1 and 2 ACM Relapsed/Refractory | CR with Incomplete Neutrophil Recovery (Cri) | 15 | participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CM Relapsed/Refractory | 11 | |
| Overall Study | STARTED | ACM Relapsed/Refractory | 79 | |
| Overall Study | STARTED | ACM Newly Diagnosed | 14 | |
| Overall Study | Stage 1 | CM Relapsed/Refractory | 0 | |
| Overall Study | Stage 1 | ACM Relapsed/Refractory | 32 | |
| Overall Study | Stage 1 | ACM Newly Diagnosed | 10 | |
| Overall Study | Stage 2 | CM Relapsed/Refractory | 11 | |
| Overall Study | Stage 2 | ACM Relapsed/Refractory | 47 | |
| Overall Study | Stage 2 | ACM Newly Diagnosed | 4 | |
| Overall Study | COMPLETED | CM Relapsed/Refractory | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events924
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 | Febrile neutropenia | Blood and lymphatic system disorders | CM Relapsed/Refractory | 4 | 11 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ACM Relapsed/Refractory | 42 | 79 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ACM Newly Diagnosed | 6 | 14 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ACM Total | 48 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | CM Relapsed/Refractory | 2 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | ACM Relapsed/Refractory | 25 | 79 | |
| other | Anaemia | Blood and lymphatic system disorders | ACM Newly Diagnosed | 2 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | ACM Total | 27 | 93 | |
| other | Leukopenia | Blood and lymphatic system disorders | CM Relapsed/Refractory | 0 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | ACM Relapsed/Refractory | 7 | 79 |
1 to 10 of 924Source ClinicalTrials.gov
See all 924 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CM Relapsed/Refractory | 1 | 11 |
| Total, all-cause mortality | ACM Relapsed/Refractory | 11 | 79 |
| Total, all-cause mortality | ACM Newly Diagnosed | 1 | 14 |
| Total, all-cause mortality | ACM Total | 12 | 93 |
| Total, other adverse events | CM Relapsed/Refractory | 11 | 11 |
| Total, other adverse events | ACM Relapsed/Refractory | 79 | 79 |
| Total, other adverse events | ACM Newly Diagnosed | 14 | 14 |
| Total, other adverse events | ACM Total | 93 | 93 |
| Total, serious adverse events | CM Relapsed/Refractory | 3 | 11 |
| Total, serious adverse events | ACM Relapsed/Refractory | 31 | 79 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT02520011
GET https://conductscience.org/api/trials/v1/NCT02520011/results?page=2