deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT04251065

Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH

A Phase II, Open Label, Multicenter Trial of Daratumumab in Combination With Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in Patients With Relapsed/Refractory CD38 Positive Peripheral T-cell Lymphoma Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell Lymphoma (AITL) and Other Nodal Lymphomas of TFH Cell Origin

Sponsor: Fondazione Italiana Linfomi - ETS

Conditions Refractory T-Cell Lymphoma Relapsed T-Cell Lymphoma
Interventions Daratumumab
Updated 12 times since 2020 Last updated: Mar 7, 2025 Started: Sep 3, 2020 Primary completion: Dec 22, 2021 Completion: Nov 23, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The enrolment was prematurely terminated after the planned monitoring of the first 5 patients because of an unacceptable level of relevant toxicities, according to statistical stopping rules and the DSMB recommendation.

Other terminated trials from Fondazione Italiana Linfomi - ETS

See all terminations from Fondazione Italiana Linfomi - ETS

Listed as NCT04251065, this PHASE2 trial focuses on Refractory T-Cell Lymphoma and Relapsed T-Cell Lymphoma and remains terminated or withdrawn. Sponsored by Fondazione Italiana Linfomi - ETS, it has been updated 12 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotNot Yet Recruiting~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshot~Sep 2022 – ~Jun 2023 · 9 months · monthly snapshotActive Not Recruiting~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshotUnknown~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

12 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE2

  2. Apr 2025 — Sep 2025 [monthly]

    Terminated PHASE2

    Status: Unknown → Terminated

  3. Sep 2024 — Apr 2025 [monthly]

    Unknown PHASE2

    Status: Active Not Recruiting → Unknown

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Jun 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

▶ Show 7 earlier versions

  1. Sep 2022 — Jun 2023 [monthly]

    Active Not Recruiting PHASE2

  2. Apr 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  4. Sep 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  5. Apr 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  6. Jan 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE2

  7. Feb 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fondazione Italiana Linfomi - ETS
Data source: Fondazione Italiana Linfomi - ETS

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations