Trial · NCT02341014
Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas
NCT02341014, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2024-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas. Trials, record NCT02341014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02341014
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas
- NCT number
- NCT02341014
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- T-cell Lymphomas, Relapsed or Refractory
- Interventions
- Carfilzomib, Romidepsin, Lenalidomide
- First posted
- 2015-01-19
- Last updated
- 2024-04-04
- Results first posted
- 2024-04-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Romidepsin | 21 days | Determine the MTD by NCI-CTCAE v4.0. |
| Primary | Maximum Tolerated Dose of Lenalidomide | 21 days | Determine the MTD by NCI-CTCAE v4.0. |
| Primary | Maximum Tolerated Dose of Carfilzomib | 21 days | Determine the MTD by NCI-CTCAE v4.0. |
| Secondary | Overall Response Rate (Orr) at the Maximum Tolerated Dose | 1 year | will be summarized using percentages and confidence intervals will be provided. ORR will be calculated based on the best response at any time during the course of treatment on this protocol. |
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 | Maximum Tolerated Dose of Romidepsin | 21 days | Phase Ib participants | mg/m^2 romidepsin | NUMBER |
| PRIMARY | Maximum Tolerated Dose of Lenalidomide | 21 days | Phase Ib participants | mg of Lenalidomide | NUMBER |
| PRIMARY | Maximum Tolerated Dose of Carfilzomib | 21 days | Phase Ib participants | mg/m^2 of Carfilzomib | NUMBER |
| SECONDARY | Overall Response Rate (Orr) at the Maximum Tolerated Dose | 1 year | T-cell Lymphoma participants evaluable for response at the maximum tolerated dose | percentage of pts with response | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Romidepsin | Phase Ib: DL 1 | 8 | mg/m^2 romidepsin | ||
| Maximum Tolerated Dose of Romidepsin | Phase Ib: DL 2 | 8 | mg/m^2 romidepsin | ||
| Maximum Tolerated Dose of Lenalidomide | Phase Ib: DL 1 | 15 | mg of Lenalidomide | ||
| Maximum Tolerated Dose of Lenalidomide | Phase Ib: DL 2 | 15 | mg of Lenalidomide | ||
| Maximum Tolerated Dose of Carfilzomib | Phase 1b: DL 1 | 36 | mg/m^2 of Carfilzomib | ||
| Maximum Tolerated Dose of Carfilzomib | Phase 1b: DL 2 | 36 | mg/m^2 of Carfilzomib | ||
| Overall Response Rate (Orr) at the Maximum Tolerated Dose | Phase 1b: DL 1 | 50 | 95% Confidence Interval 12 to 88 | percentage of pts with response | |
| Overall Response Rate (Orr) at the Maximum Tolerated Dose | Phase 1b: DL 2 | 57 | 95% Confidence Interval 18 to 90 | percentage of pts with response | |
| Overall Response Rate (Orr) at the Maximum Tolerated Dose | Phase IIa - MTD | 42 | 95% Confidence Interval 15 to 72 | percentage of pts with response |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase Ib: DL 1 | 6 | |
| Overall Study | STARTED | Phase Ib: DL 2 | 7 | |
| Overall Study | STARTED | Phase Ib: DL 3 | 0 | |
| Overall Study | STARTED | Phase Ib: DL 4 | 0 | |
| Overall Study | STARTED | Phase IIa - MTD | 14 | |
| Overall Study | COMPLETED | Phase Ib: DL 1 | 6 | |
| Overall Study | COMPLETED | Phase Ib: DL 2 | 6 | |
| Overall Study | COMPLETED | Phase Ib: DL 3 | 0 | |
| Overall Study | COMPLETED | Phase Ib: DL 4 | 0 | |
| Overall Study | COMPLETED | Phase IIa - MTD | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events125
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 | Anemia | Blood and lymphatic system disorders | Phase Ib: DL 1 | 0 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Phase Ib: DL 2 | 2 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Phase Ib: DL 3 | 0 | ||
| other | Anemia | Blood and lymphatic system disorders | Phase Ib: DL 4 | 0 | ||
| other | Anemia | Blood and lymphatic system disorders | Phase IIa - MTD | 0 | 14 | |
| other | Platelet count decreased | Investigations | Phase Ib: DL 1 | 1 | 6 | |
| other | Platelet count decreased | Investigations | Phase Ib: DL 2 | 3 | 7 | |
| other | Platelet count decreased | Investigations | Phase Ib: DL 3 | 0 | ||
| other | Platelet count decreased | Investigations | Phase Ib: DL 4 | 0 | ||
| other | Platelet count decreased | Investigations | Phase IIa - MTD | 2 | 14 |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase Ib: DL 1 | 4 | 6 |
| Total, all-cause mortality | Phase Ib: DL 2 | 6 | 7 |
| Total, all-cause mortality | Phase Ib: DL 3 | 0 | 0 |
| Total, all-cause mortality | Phase Ib: DL 4 | 0 | 0 |
| Total, all-cause mortality | Phase IIa - MTD | 8 | 14 |
| Total, other adverse events | Phase Ib: DL 1 | 2 | 6 |
| Total, other adverse events | Phase Ib: DL 2 | 6 | 7 |
| Total, other adverse events | Phase Ib: DL 3 | 0 | 0 |
| Total, other adverse events | Phase Ib: DL 4 | 0 | 0 |
| Total, other adverse events | Phase IIa - MTD | 5 | 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT02341014
GET https://conductscience.org/api/trials/v1/NCT02341014/events?page=2