Maximum Tolerated Dose of Romidepsin
Primary
· 21 days
Determine the MTD by NCI-CTCAE v4.0.
| Group | Value | 95% CI |
|---|---|---|
| Phase Ib: DL 1 | 8 | |
| Phase Ib: DL 2 | 8 |
Last reviewed · How we verify
NCT02341014
Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas
Completed
Phase 1, PHASE2
Results posted
Last updated 4 April 2024
What this trial tests
Phase 1, PHASE2 trial testing Carfilzomib in T-cell Lymphomas in 27 participants. Completed in 11 January 2023.
Timeline
2 January 2015
Primary endpoint
11 January 2023
11 January 2023
11 January 2023
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 2 January 2015 |
| Primary completion | 11 January 2023 |
| Estimated completion | 11 January 2023 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Carfilzomib (carfilzomib) — full drug profile →
- Romidepsin (ROMIDEPSIN) — full drug profile →
- Lenalidomide — full drug profile →
Conditions studied
- T-cell Lymphomas — all drugs for T-cell Lymphomas →
- Relapsed or Refractory — all drugs for Relapsed or Refractory →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
18 and older, any sex, with T-cell Lymphomas or Relapsed or Refractory. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose of Lenalidomide
Primary
· 21 days
Determine the MTD by NCI-CTCAE v4.0.
| Group | Value | 95% CI |
|---|---|---|
| Phase Ib: DL 1 | 15 | |
| Phase Ib: DL 2 | 15 |
Maximum Tolerated Dose of Carfilzomib
Primary
· 21 days
Determine the MTD by NCI-CTCAE v4.0.
| Group | Value | 95% CI |
|---|---|---|
| Phase 1b: DL 1 | 36 | |
| Phase 1b: DL 2 | 36 |
Overall Response Rate (Orr) at the Maximum Tolerated Dose
Secondary
· 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.
| Group | Value | 95% CI |
|---|---|---|
| Phase 1b: DL 1 | 50 | 12 – 88 |
| Phase 1b: DL 2 | 57 | 18 – 90 |
| Phase IIa - MTD | 42 | 15 – 72 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase Ib: DL 1
Serious: 0/6 (0%)
Deaths: 4/6
Phase Ib: DL 2
Serious: 5/7 (71%)
Deaths: 6/7
Phase Ib: DL 3
Serious: 0
Deaths: 0
Phase Ib: DL 4
Serious: 0
Deaths: 0
Phase IIa - MTD
Serious: 3/14 (21%)
Deaths: 8/14
Serious adverse events (16 terms)
| Reaction | System | Phase Ib: DL 1 | Phase Ib: DL 2 | Phase Ib: DL 3 | Phase Ib: DL 4 | Phase IIa - MTD |
|---|---|---|---|---|---|---|
| Fever | General disorders | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — |
| Death NOS | General disorders | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Edema | General disorders | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Heart failure | Cardiac disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Lung infection | Infections and infestations | — | — | — | — | — |
| Thromboembolic event | Vascular disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Thrombocytopenia | Investigations | — | — | — | — | — |
Other adverse events (9 terms — click to expand)
| Reaction | System | Phase Ib: DL 1 | Phase Ib: DL 2 | Phase Ib: DL 3 | Phase Ib: DL 4 | Phase IIa - MTD |
|---|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — | — |
| Weight loss | Investigations | — | — | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — | — |
Most-reported serious reactions: Fever, Anemia, Chills, Death NOS, Dehydration, Diarrhea, Dyspnea, Edema.
Data from ClinicalTrials.gov NCT02341014 adverse events section.
Sponsor's own description
This is an open label phase Ib/IIa study of patients with relapsed/refractory B- and T-cell lymphomas who are treated with carfilzomib, lenalidomide and romidepsin.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0 -
Mechanisms of Action of Lenalidomide in B-Cell Non-Hodgkin Lymphoma.
Gribben JG, Fowler N, Morschhauser F. · · 2015 · cited 231× · PMID 26195701 · DOI 10.1200/jco.2014.59.5363 -
Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6 -
T follicular helper phenotype predicts response to histone deacetylase inhibitors in relapsed/refractory peripheral T-cell lymphoma.
Ghione P, Faruque P, Mehta-Shah N, Seshan V, et al · · 2020 · cited 81× · PMID 33002132 · DOI 10.1182/bloodadvances.2020002396 -
Histone Deacetylases (HDACs) Guided Novel Therapies for T-cell lymphomas.
Zhang Q, Wang S, Chen J, Yu Z. · · 2019 · cited 72× · PMID 30911277 · DOI 10.7150/ijms.30154 -
Romidepsin for the Treatment of Peripheral T-Cell Lymphoma.
Iyer SP, Foss FF. · · 2015 · cited 52× · PMID 26099743 · DOI 10.1634/theoncologist.2015-0043 -
Novel targeted therapies of T cell lymphomas.
Iżykowska K, Rassek K, Korsak D, Przybylski GK, et al · · 2020 · cited 49× · PMID 33384022 · DOI 10.1186/s13045-020-01006-w -
Targeting Histone Deacetylases: Opportunities for Cancer Treatment and Chemoprevention.
Ruzic D, Djoković N, Srdić-Rajić T, Echeverria C, et al · · 2022 · cited 46× · PMID 35057104 · DOI 10.3390/pharmaceutics14010209
Verify or expand the search:
- PubMed search for NCT02341014
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02341014 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 4 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02341014.
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