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NCT03355768
Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL
Phase 3 trial testing Romidepsin in Lymphoma, T-Cell, Peripheral. Withdrawn.
1 November 2018
Quick facts
| Lead sponsor | Jennifer Amengual |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Start date | 1 September 2018 |
| Primary completion | 1 November 2018 |
| Estimated completion | 1 November 2018 |
Drugs / interventions tested
- Romidepsin (ROMIDEPSIN) — full drug profile →
- Pralatrexate — full drug profile →
Conditions studied
- Lymphoma, T-Cell, Peripheral — all drugs for Lymphoma, T-Cell, Peripheral →
Sponsor
Jennifer Amengual — full company profile →
Who can join
Adults 18 to 90, any sex, with Lymphoma, T-Cell, Peripheral. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03355768
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Romidepsin
Trials testing the same drug.
- NCT04639843 — Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma · Phase 1 · withdrawn
- NCT04774068 — Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas · Phase 1 · completed
- NCT04747236 — Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL · Phase 2 · recruiting
- NCT04447027 — Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies · Phase 1 · completed
- NCT04257448 — Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From · Phase 1, PHASE2 · completed
Other recruiting trials for Lymphoma, T-Cell, Peripheral
Currently open trials in the same condition.
- NCT06254495 — A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers · Phase 1 · active not recruiting
Other Jennifer Amengual trials
Trials by the same sponsor.
- NCT06954805 — Defining ctDNA Metrics in Posttransplant Lymphoproliferative Disorder (PTLD) · Phase 2 · recruiting
- NCT02091063 — ACY-1215 for Relapsed/Refractory Lymphoid Malignancies · Phase 1, PHASE2 · terminated
- NCT01947140 — Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03355768 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jennifer Amengual
- Last refreshed: 19 December 2018
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/NCT03355768.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing