Trial · NCT03770000
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
NCT03770000, Phase 1, Phase 2, Completed, Rhizen Pharmaceuticals SA; results first posted 2022-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma. Trials, record NCT03770000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03770000
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
- NCT number
- NCT03770000
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Conditions
- T Cell Lymphoma
- Interventions
- Tenalisib, Romidepsin
- First posted
- 2018-12-10
- Last updated
- 2022-10-28
- Results first posted
- 2022-10-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With and Without Dose Limiting Toxicities (DLTs) | 28 days | The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. |
| Secondary | Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination | 12 weeks | Overall response (ORR) = CR + PR) was assessed according to the Lugano classification with PTCL and according to the modified Severity Weighted Assessment Tool (mSWAT)/Global assessment in patients with CTCL. |
| Secondary | Duration of Response (DoR) With Tenalisib and Romidepsin Combination | 28 weeks | The time period from the response achieved in patient until the disease progression |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | 8 days | Assessment of Cmax in subjects treated with Tenalisib and Romidepsin combination. Blood samples for measurement of RP6530 plasma concentrations were collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 11 hours after dosing on Day 8 of the first cycle. Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With and Without Dose Limiting Toxicities (DLTs) | 28 days | DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) of treatment with Tenalisib and Romidepsin combination and is considered related to combination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination | 12 weeks | Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) With Tenalisib and Romidepsin Combination | 28 weeks | Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR | days | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | 8 days | Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 8. | nanogram/millilitre | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose escalation_Cohort 1 | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose escalation_Cohort 2 | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose escalation_Cohort 3 | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose expansion_Group 1 (PTCL) | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose expansion_Group 2 (CTCL) | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose escalation_Cohort 1 | No.of Participants without Dose Limiting Toxicities | 3 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose escalation_Cohort 2 | No.of Participants without Dose Limiting Toxicities | 3 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose escalation_Cohort 3 | No.of Participants without Dose Limiting Toxicities | 3 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose expansion_Group 1 (PTCL) | No.of Participants without Dose Limiting Toxicities | 0 | Participants | |
| Number of Participants With and Without Dose Limiting Toxicities (DLTs) | Dose expansion_Group 2 (CTCL) | No.of Participants without Dose Limiting Toxicities | 0 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose escalation_Cohort 1 | 3 | |
| Overall Study | STARTED | Dose escalation_Cohort 2 | 3 | |
| Overall Study | STARTED | Dose escalation_Cohort 3 | 3 | |
| Overall Study | STARTED | Dose expansion_Group 1 (PTCL) | 12 | |
| Overall Study | STARTED | Dose expansion_Group 2 (CTCL) | 12 | |
| Overall Study | COMPLETED | Dose escalation_Cohort 1 | 3 | |
| Overall Study | COMPLETED | Dose escalation_Cohort 2 | 3 | |
| Overall Study | COMPLETED | Dose escalation_Cohort 3 | 2 | |
| Overall Study | COMPLETED | Dose expansion_Group 1 (PTCL) | 9 | |
| Overall Study | COMPLETED | Dose expansion_Group 2 (CTCL) | 10 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events190
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 | Thrombocytopenia | Blood and lymphatic system disorders | Dose escalation_Cohort 1 | 3 | 3 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose escalation_Cohort 2 | 2 | 3 | 6 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose escalation_Cohort 3 | 2 | 3 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose expansion_Group 1 (PTCL) | 8 | 12 | 33 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose expansion_Group 2 (CTCL) | 4 | 12 | 11 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose escalation_Cohort 1 | 1 | 3 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose escalation_Cohort 2 | 1 | 3 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose escalation_Cohort 3 | 0 | 3 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose expansion_Group 1 (PTCL) | 5 | 12 | 24 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose expansion_Group 2 (CTCL) | 2 | 12 | 18 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose escalation_Cohort 1 | 0 | 3 |
| Total, all-cause mortality | Dose escalation_Cohort 2 | 0 | 3 |
| Total, all-cause mortality | Dose escalation_Cohort 3 | 0 | 3 |
| Total, all-cause mortality | Dose expansion_Group 1 (PTCL) | 1 | 12 |
| Total, all-cause mortality | Dose expansion_Group 2 (CTCL) | 1 | 12 |
| Total, other adverse events | Dose escalation_Cohort 1 | 3 | 3 |
| Total, other adverse events | Dose escalation_Cohort 2 | 3 | 3 |
| Total, other adverse events | Dose escalation_Cohort 3 | 3 | 3 |
| Total, other adverse events | Dose expansion_Group 1 (PTCL) | 12 | 12 |
| Total, other adverse events | Dose expansion_Group 2 (CTCL) | 12 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37439343 | 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/NCT03770000
GET https://conductscience.org/api/trials/v1/NCT03770000/results?page=2