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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522595-87-00 | EU Trial (CTIS) Number |
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This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.
DS3790a may be effective in the treatment of patients with hematological malignancies. The primary objective of this study will assess the safety and preliminary efficacy of DS3790a monotherapy and combination regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Escalation Phase | Experimental | Participants with hematological malignancies who received DS3790a monotherapy. |
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| Monotherapy Dose Expansion Phase | Experimental | Participants with hematological malignancies who received DS3790a monotherapy. |
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| Cohort A Combination Dose-escalation Phase | Experimental | Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
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| Cohort A Randomization/Optimization Phase | Experimental | Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
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| Cohort A Phase 2 | Experimental | Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS3790a | Drug | Administered as specified in the protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Dose-limiting Toxicities, Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, and Deaths in Participants With Hematological Malignancies | Adverse events (AEs) will be graded using NCI-CTCAE version 5.0. | Baseline up to 5 years |
| Complete Response in Participants With Hematological Malignancies by Blinded Independent Central Review (Cohort A Randomization Optimization Phase, Cohort A Phase 2) | Complete Response (CR) is defined as participants with CR as measured by BICR assessment. | Baseline up to 5 years |
| Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase) | Complete Response (CR) is defined as participants with CR as measured by investigator assessment. | Baseline up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response by Investigator Assessment In Participants With Hematological Malignancies | Objective response (OR) is defined as participants with complete response (CR) or partial response (PR) as measured by investigator assessment. | Baseline up to 5 years |
| Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation) |
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To be eligible to participate in this trial, an individual must meet all the following criteria:
An individual who meets any of the following criteria will be excluded from participating in this trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daiichi Sankyo Contact for Clinical Trial Information | Contact | 908-992-6400 | CTRinfo_us@daiichisankyo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | New York | New York | 10065 | United States |
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Completed studies that have reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Cohort B Combination Dose-escalation Phase | Experimental | Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
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| Cohort B Randomization/Optimization Phase | Experimental | Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
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| Standard of Care | Active Comparator | Participants with hematological malignancies who received standard of care (SoC). |
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| Combination drug | Drug | Administered as specified in the protocol |
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| Combination drug | Drug | Administered as specified in the protocol |
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Complete response (CR) is defined as participants with CR as best overall response (BOR) as measured by investigator assessment. |
| Baseline up to 5 years |
| Disease Control in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation) | Disease control (DC) is defined as participants with CR, PR or stable disease as BOR as measured by investigator assessment. | Baseline up to 5 years |
| Duration of Complete Response and Duration of Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation) | Duration of Complete Response (DoCR) is defined as the time from the date of first documentation of CR to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoCR will be calculated for responders (CR) only. Duration of Response (DoR) is defined as the time from the date of first documentation of objective response (CR or PR) to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoR will be calculated for responders (CR or PR) only. | Baseline up to 5 years |
| Time to Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation) | Time to Response (TTR) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of the first documentation of objective response (CR or PR) by investigator assessment. TTR will be calculated for responders (CR or PR) only. | Baseline up to 5 years |
| Progression-free Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation) | Progression-free Survival (PFS) is defined as time from the date of the start of trial intervention or randomization if randomized, to the date of radiographic disease progression, defined as the first documented objective PD by investigator assessment or death due to any cause. | Baseline up to 5 years |
| Overall Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation) | Overall Survival (OS) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of death due to any cause. | Baseline up to 5 years |
| Research Site | Recruiting | Lille | 59037 | France |
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| Research Site | Recruiting | Pierre-Bénite | 69495 | France |
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| Research Site | Recruiting | Nagoya | 464-8681 | Japan |
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| Research Site | Recruiting | Tokyo | 104-0045 | Japan |
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| Research Site | Recruiting | Tokyo | 135-8550 | Japan |
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| D008228 |
| Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |