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NCT04156828 · ClinicalTrials.gov registry record · Phase 1
Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma
A Phase 1 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04156828: Clinical Trial Phase 1 study, sponsored by University of Washington.
NCT04156828 is a Phase 1 study that was terminated before completion, run by University of Washington. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04156828, a Phase 1 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.
Primary Outcome
Will assess the presence of a DLT in the first cycle of treatment The dose that estimate of the maximum tolerated dose (MTD) will be obtained using the continuous reassessment method (CRM). Moreover, the proportion of DLT at each dose level will be reported along with the final estimates of the probability of DLT at the MTD based on the CRM along with the 95% confidence interval.
Interventions
- DRUG Carboplatin
- DRUG Dexamethasone
- DRUG Gemcitabine
- BIOLOGICAL Rituximab
- DRUG Copanlisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2023-06-08 |
| Phase | Phase 1 |
Why NCT04156828 stopped before completion
NCT04156828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT04156828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04156828 about?
NCT04156828 is a clinical study titled "Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma". This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (rel...
What is the current status of trial NCT04156828?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-03-31. Estimated completion is 2023-06-08.
What interventions are being tested in trial NCT04156828?
The interventions under investigation include: Carboplatin (DRUG), Dexamethasone (DRUG), Gemcitabine (DRUG), Rituximab (BIOLOGICAL), Copanlisib (DRUG).
Who is sponsoring clinical trial NCT04156828?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04156828's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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