Trial · NCT03298984
Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).
NCT03298984, Phase 1, Completed, Sumitomo Pharma America, Inc.; results first posted 2021-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML). Trials, record NCT03298984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03298984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).
- NCT number
- NCT03298984
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Alvocidib, Cytarabine, Daunorubicin
- First posted
- 2017-10-02
- Last updated
- 2023-11-15
- Results first posted
- 2021-05-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Alvocidib | During the first cycle | Determine the safety and tolerability including the maximum tolerated dose (MTD) of alvocidib when administered over a range of doses on Days 1-3 followed by Ara-c/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML |
| Primary | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) of Alvocidib | During the first cycle | Determine the safety and tolerability including dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by Ara-c/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML |
| Secondary | Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria | Best response during duration of study | CR: Measurable residual disease is positive or unknown; BM blasts (bls) \<5%; no circulating bls and bls w/ Auer rods; no extramedullary disease; ANC \>1.0 x 109/L; platelets \>100 x 109/L. CRMRD-: CR w/ negativity genetic marker. CRi: CR except residual neutropenia or thrombocytopenia. MLFS: BM bls \<5%; no bls with Auer rods; no extramedullary disease; no hematologic recovery required. PR: all hematologic CR criteria; decrease (dec) BM bls % to 5-25%; dec pretreatment BM bls % by \>50%. SD: no CRMRD-/CR/CRi/PR/MLFS; PD criteria not met. PD: increase (inc) BM bls % and/or inc absolute bls in blood: 50% inc BM bls over baseline (\>15% point inc required in cases w/ \<30% bls at baseline or persistent BM bls % of \>70% over at least 3 months; without at least 100% improvement in ANC to absolute level \[\>0.5 x 109/L and/or platelet count to \>50 x 109/L non-transfused); or \>50% inc in peripheral bls to \>25 x 109/L (in the absence of differentiation syndrome); or new extramedullary disease. |
| Secondary | Recommended Phase 2 Dose (RP2D) of Alvocidib in Combination With 7+3 | During Cycle 1 beginning at 1st dose of study drug through Day 50 + or - 3 days | The dose at which \< 1 of 6 patients experience a DLT during Cycle 1 with the next higher dose having at least 2 of 3 to 6 patients experiencing a DLT during Cycle 1 |
| Other | Minimal Residual Disease (MRD) Using Standardized Techniques | During duration of study | Percentage of participants with a CRMRD- response at the end of Cycle 1 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Alvocidib | During the first cycle | mg/m2 | NUMBER | |
| PRIMARY | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) of Alvocidib | During the first cycle | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria | Best response during duration of study | participants | NUMBER | |
| SECONDARY | Recommended Phase 2 Dose (RP2D) of Alvocidib in Combination With 7+3 | During Cycle 1 beginning at 1st dose of study drug through Day 50 + or - 3 days | mg/m2 | NUMBER | |
| OTHER_PRE_SPECIFIED | Minimal Residual Disease (MRD) Using Standardized Techniques | During duration of study | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Alvocidib | All Participants | Bolus | 30 | mg/m2 | |
| Maximum Tolerated Dose (MTD) of Alvocidib | All Participants | IV infusion | 60 | mg/m2 | |
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) of Alvocidib | Alvocidib 20/30 mg/m2 | 0 | Participants | ||
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) of Alvocidib | Alvocidib 30/40 mg/m2 | 0 | Participants | ||
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) of Alvocidib | Alvocidib 30/50 mg/m2 | 0 | Participants | ||
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) of Alvocidib | Alvocidib 30/60 mg/m2 | 1 | Participants | ||
| Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria | Alvocidib 20/30 mg/m2 | Complete Remission MRD Negative (CRMRD-) | 2 | participants | |
| Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria | Alvocidib 30/40 mg/m2 | Complete Remission MRD Negative (CRMRD-) | 0 | participants | |
| Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria | Alvocidib 30/50 mg/m2 | Complete Remission MRD Negative (CRMRD-) | 2 | participants | |
| Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria | Alvocidib 30/60 mg/m2 | Complete Remission MRD Negative (CRMRD-) | 8 | participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alvocidib 20/30 mg/m2 | 3 | |
| Overall Study | STARTED | Alvocidib 30/40 mg/m2 | 3 | |
| Overall Study | STARTED | Alvocidib 30/50 mg/m2 | 3 | |
| Overall Study | STARTED | Alvocidib 30/60 mg/m2 | 23 | |
| Overall Study | COMPLETED | Alvocidib 20/30 mg/m2 | 2 | |
| Overall Study | COMPLETED | Alvocidib 30/40 mg/m2 | 2 | |
| Overall Study | COMPLETED | Alvocidib 30/50 mg/m2 | 1 | |
| Overall Study | COMPLETED | Alvocidib 30/60 mg/m2 | 8 | |
| Overall Study | NOT COMPLETED | Alvocidib 20/30 mg/m2 | 1 | |
| Overall Study | NOT COMPLETED | Alvocidib 30/40 mg/m2 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events660
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 | Alvocidib 20/30 mg/m2 (N=3) | 3 | 3 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Alvocidib 30/40 mg/m2 (N=3) | 2 | 3 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Alvocidib 30/50 mg/m2 (N=3) | 3 | 3 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Alvocidib 30/60 mg/m2 (N=23) | 19 | 23 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Alvocidib 20/30 mg/m2 (N=3) | 0 | 3 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Alvocidib 30/40 mg/m2 (N=3) | 0 | 3 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Alvocidib 30/50 mg/m2 (N=3) | 0 | 3 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Alvocidib 30/60 mg/m2 (N=23) | 3 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Alvocidib 20/30 mg/m2 (N=3) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Alvocidib 30/40 mg/m2 (N=3) | 0 | 3 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alvocidib 20/30 mg/m2 (N=3) | 0 | 3 |
| Total, all-cause mortality | Alvocidib 30/40 mg/m2 (N=3) | 0 | 3 |
| Total, all-cause mortality | Alvocidib 30/50 mg/m2 (N=3) | 0 | 3 |
| Total, all-cause mortality | Alvocidib 30/60 mg/m2 (N=23) | 2 | 23 |
| Total, other adverse events | Alvocidib 20/30 mg/m2 (N=3) | 3 | 3 |
| Total, other adverse events | Alvocidib 30/40 mg/m2 (N=3) | 3 | 3 |
| Total, other adverse events | Alvocidib 30/50 mg/m2 (N=3) | 3 | 3 |
| Total, other adverse events | Alvocidib 30/60 mg/m2 (N=23) | 23 | 23 |
| Total, serious adverse events | Alvocidib 20/30 mg/m2 (N=3) | 1 | 3 |
| Total, serious adverse events | Alvocidib 30/40 mg/m2 (N=3) | 0 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32998965 | DERIVED |
Source PubMed
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/NCT03298984
GET https://conductscience.org/api/trials/v1/NCT03298984/results?page=2