Trial · NCT03969420
Study of Alvocidib in Patients With Relapsed/Refractory AML Following Treatment With Venetoclax Combination Therapy
NCT03969420, Phase 2, Terminated, Sumitomo Pharma America, Inc.; results first posted 2022-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Alvocidib in Patients With Relapsed/Refractory AML Following Treatment With Venetoclax Combination Therapy. Trials, record NCT03969420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03969420
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Alvocidib in Patients With Relapsed/Refractory AML Following Treatment With Venetoclax Combination Therapy
- NCT number
- NCT03969420
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Alvocidib (flavopiridol) and cytarabine (Ara-C), Alvocidib (flavopiridol)
- First posted
- 2019-05-31
- Last updated
- 2023-11-09
- Results first posted
- 2022-10-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Combined Complete Remission | Response assessments were measured from date of first dose through End of Treatment date, an average of 3 months. | Rate of combined complete remission (complete remission (CR) + CR with incomplete hematological recovery (CRi)), as defined by the International Working Group Criteria and 2017 European LeukemiaNet). Combined complete remissions (patients with a best response of CR or CRi), complete remissions, composite complete remissions (patients with a best response of CR, CRi or CRh), and combined responses (patients with a best response of CR, CRi, CRh, MLFS or PR) will be summarized by observed response rates and estimated 95% CIs. |
| Secondary | Median Overall Survival | From first dose until disease progression or death; through study termination, an average of 10 months | Time from treatment (Day 1) until death from any cause |
| Secondary | Complete Response Rate | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | Percentage of patients achieving complete response (CR) whose bone marrow is determined to be negative for minimal residual disease (MRD) using standardized techniques (ie, multiparametric flow cytometry \[MPFC\] and molecular testing including next generation sequencing \[NGS\] |
| Secondary | Composite CR Rate | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | Patients with a best response of CR + CRi + CRh (CR + partial recovery of both blood cell types) |
| Secondary | Combined Response Rate | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | Combined Percentage of Patients Achieving One of the Following: CR \< CRi, CRh, MLFS, PR Morphologic leukemia-free state (MLFS) = Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Response (PR) = Meets all hematologic values required for CR but with a decrease of at least 50% in the percentage of blasts to ≥5% to ≤25% in bone marrow |
| Secondary | Event Free Survival (EFS) | From first dose until disease progression or death; through study termination, an average of 10 months | Event Free Survival - time from first treatment (D1) until (a) treatment failure, (b) relapse after CR/Cri or CRh, or (c) death from any cause, whichever occurs first |
| Secondary | Duration of Composite Complete Remission (CR) | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | Duration of Composite CR, defined as the time from first documented response of CR, CRi or CRhi to relapse or death from any cause |
| Secondary | Transfusion Independence | Transfusion dependence was measured from 28 days prior to first dose through 56 days after last dose, an average of 6 months | Rates of 28- and 56-day Transfusion Independence (TI) = Percentages of patients who do not receive red blood cell (RBC) transfusions, platelet (PLT) transfusions, and neither RBC nor PLT transfusions for 28 and 56 days; comprised of 6 secondary endpoints |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Combined Complete Remission | Response assessments were measured from date of first dose through End of Treatment date, an average of 3 months. | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | ||
| SECONDARY | Median Overall Survival | From first dose until disease progression or death; through study termination, an average of 10 months | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | ||
| SECONDARY | Complete Response Rate | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | ||
| SECONDARY | Composite CR Rate | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | ||
| SECONDARY | Combined Response Rate | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | ||
| SECONDARY | Event Free Survival (EFS) | From first dose until disease progression or death; through study termination, an average of 10 months | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | ||
| SECONDARY | Duration of Composite Complete Remission (CR) | Response assessments were measured from date of first dose through end of treatment date, an average of 3 months | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. | ||
| SECONDARY | Transfusion Independence | Transfusion dependence was measured from 28 days prior to first dose through 56 days after last dose, an average of 6 months | The sponsor decided not to continue the study based on the overall company strategy in AML. Data collection and analysis were not conducted. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lead-In Cohort: Arm 1 | 3 | |
| Overall Study | STARTED | Lead-In Cohort: Arm 2 | 4 | |
| Overall Study | STARTED | Stage 1: Arm 1 | 2 | |
| Overall Study | STARTED | Stage 1: Arm 2 | 2 | |
| Overall Study | COMPLETED | Lead-In Cohort: Arm 1 | 3 | |
| Overall Study | COMPLETED | Lead-In Cohort: Arm 2 | 4 | |
| Overall Study | COMPLETED | Stage 1: Arm 1 | 2 | |
| Overall Study | COMPLETED | Stage 1: Arm 2 | 2 | |
| Overall Study | NOT COMPLETED | Lead-In Cohort: Arm 1 | 0 | |
| Overall Study | NOT COMPLETED | Lead-In Cohort: Arm 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events312
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 | Diarrhoea | Gastrointestinal disorders | Lead-In Cohort: Arm 1 | 2 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | Lead-In Cohort: Arm 2 | 2 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Stage 1: Arm 1 | 1 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Stage 1: Arm 2 | 0 | 2 | |
| other | nausea | Gastrointestinal disorders | Lead-In Cohort: Arm 1 | 0 | 3 | |
| other | nausea | Gastrointestinal disorders | Lead-In Cohort: Arm 2 | 1 | 4 | |
| other | nausea | Gastrointestinal disorders | Stage 1: Arm 1 | 2 | 2 | |
| other | nausea | Gastrointestinal disorders | Stage 1: Arm 2 | 1 | 2 | |
| other | vomiting | Gastrointestinal disorders | Lead-In Cohort: Arm 1 | 1 | 3 | |
| other | vomiting | Gastrointestinal disorders | Lead-In Cohort: Arm 2 | 1 | 4 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lead-In Cohort: Arm 1 | 2 | 3 |
| Total, all-cause mortality | Lead-In Cohort: Arm 2 | 3 | 4 |
| Total, all-cause mortality | Stage 1: Arm 1 | 1 | 2 |
| Total, all-cause mortality | Stage 1: Arm 2 | 1 | 2 |
| Total, other adverse events | Lead-In Cohort: Arm 1 | 3 | 3 |
| Total, other adverse events | Lead-In Cohort: Arm 2 | 4 | 4 |
| Total, other adverse events | Stage 1: Arm 1 | 2 | 2 |
| Total, other adverse events | Stage 1: Arm 2 | 2 | 2 |
| Total, serious adverse events | Lead-In Cohort: Arm 1 | 2 | 3 |
| Total, serious adverse events | Lead-In Cohort: Arm 2 | 3 | 4 |
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/NCT03969420
GET https://conductscience.org/api/trials/v1/NCT03969420/events?page=2