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NCT03770000 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

A Phase 1 study, sponsored by Rhizen Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target

NCT03770000: Completed Phase 1 study, sponsored by Rhizen Pharmaceuticals.

NCT03770000 is a Phase 1 study that has completed, run by Rhizen Pharmaceuticals. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03770000, a Phase 1 study, has completed, sponsored by Rhizen Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target

Study Summary

To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.

Primary Outcome

The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

Interventions

  • DRUG Romidepsin
  • DRUG Tenalisib

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2019-03-12
Est. Completion 2021-05-14
Phase Phase 1
Rhizen Pharmaceuticals

7 total trials

What the finished NCT03770000 record still lists

NCT03770000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 2 interventions - of which Romidepsin is the first listed.

NCT03770000 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03770000 about?

NCT03770000 is a clinical study titled "Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma". To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.

What is the current status of trial NCT03770000?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2019-03-12. Estimated completion is 2021-05-14.

What interventions are being tested in trial NCT03770000?

The interventions under investigation include: Romidepsin (DRUG), Tenalisib (DRUG).

Who is sponsoring clinical trial NCT03770000?

This trial is sponsored by Rhizen Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03770000's enrollment target sits among peer trials

33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03770000, the US trial registry maintained by the National Library of Medicine. NCT03770000 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.