Trial · NCT03563560
A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia
NCT03563560, Phase 1, Completed, Sumitomo Pharma Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia. Trials, record NCT03563560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03563560
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia
- NCT number
- NCT03563560
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Alvocidib, Cytarabine, Mitoxantrone, Cytarabine, Daunorubicine
- First posted
- 2018-06-20
- Last updated
- 2022-04-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate safety and tolerability in Japanese AML patients by CTCAE v4.0 | 2 months | Safety and tolerability of DSP-2033 (Alvocidib) in combination with cytarabine/mitoxantrone (ACM regimen) in Japanese patients with relapsed or refractory AML and in combination with cytarabine/daunorubicin (A+7+3 regimen) in Japanese newly diagnosed AML patients. Safety and tolerability analyses:The number of subjects with treatment-related adverse events as assessed by CTCAE v4.0. The number of subjects with DLT and incidence rate during the DLT evaluation period. |
| Secondary | To evaluate peak plasma concentration (Cmax) of ACM regimen and A+7+3 regimen in Japanese | 14 days | Pharmacokinetics of individual drugs of ACM regimen in Japanese patients with relapsed or refractory AML and A+7+3 regimen in Japanese newly diagnosed AML patients. Pharmacokinetic analyses:Pharmacokinetic parameters of Maximum Plasma Concentration \[Cmax\] DSP-2033, DSP-2033 glucuronide (Alvo-G), cytarabine, mitoxantrone, and daunorubicin. |
| Secondary | To evaluate Area under the plasma concentration versus time curve (AUC) of ACM regimen and A+7+3 regimen in Japanese | 14 days | Pharmacokinetics of individual drugs of ACM regimen in Japanese patients with relapsed or refractory AML and A+7+3 regimen in Japanese newly diagnosed AML patients. Pharmacokinetic analyses:Pharmacokinetic parameters of Area Under the Curve \[AUC\] DSP-2033, DSP-2033 glucuronide (Alvo-G), cytarabine, mitoxantrone, and daunorubicin. |
| Secondary | To evaluate the Anti-tumor effects based on bone-marrow blasts | 2 months | * Complete remission rate (CR rate) * CR with incomplete hematologic recovery (CRi rate) * Combined Complete remission rate (CRc rate): a total of CR rate and CRi rate * Partial remission rate (PR rate) (Evaluated by 2017 European Leukemia Net AML efficacy assessment criteria) |
| Secondary | Event-free survival (EFS) (ACM regimen part only) | 12 months | EFS of ACM regimen in Japanese patients with relapsed or refractory AML. |
| Secondary | Overall survival (OS) (ACM regimen part only) | 12 months | OS of ACM regimen in Japanese patients with relapsed or refractory AML. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35689544 | 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/NCT03563560
GET https://conductscience.org/api/trials/v1/NCT03563560/registered