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NCT01165112 · ClinicalTrials.gov registry record · Phase 1
Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma
A Phase 1 study of Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Adult Hodgkin Lymphoma, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01165112: Completed Phase 1 study of Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Adult Hodgkin Lymphoma, sponsored by University of Washington.
NCT01165112 is a Phase 1 study of Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Adult Hodgkin Lymphoma that has completed, run by University of Washington. The registered enrollment target is 48 participants, above the 38-participant average among 10 other Recurrent Adult Diffuse Large Cell Lymphoma trials with a reported enrollment target (26% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01165112, a Phase 1 study of Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Adult Hodgkin Lymphoma, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving bendamustine hydrochloride together with carboplatin, etoposide, and rituximab may kill more cancer cells.
Primary Outcome
Defined as dose at which approximately =\< 25% of patients experience a DLT. Following completed observation of final patient, two-parameter logistic model fit to data, generating dose-response curve based on observed toxicity rate at dose levels visited. Based on this fitted model, MTD is estimated to be dose that is associated with toxicity rate of 25%. If estimate of slope parameter for fitted curve is not positive and finite, geometric mean of dose level used for last cohort and dose level t
Conditions Studied
Interventions
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Etoposide
- BIOLOGICAL Rituximab
- DRUG Bendamustine Hydrochloride
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT01165112 record still lists
NCT01165112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, above the 38-participant average among 10 other Recurrent Adult Diffuse Large Cell Lymphoma trials with a reported enrollment target (26% higher).
The record links to 2 conditions, with Recurrent Adult Diffuse Large Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01165112 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01165112 about?
NCT01165112 is a clinical study titled "Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma". This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a period of improvement or has not respon...
What is the current status of trial NCT01165112?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2010-09. Estimated completion is 2015-06.
What conditions does trial NCT01165112 study?
This clinical trial studies the following conditions: Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma.
What interventions are being tested in trial NCT01165112?
The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Etoposide (DRUG), Rituximab (BIOLOGICAL), Bendamustine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01165112?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01165112 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Adult Diffuse Large Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01165112's enrollment target sits among peer trials
48 2nd of 10 higher than 8 of 10 other Recurrent Adult Diffuse Large Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Adult Diffuse Large Cell Lymphoma 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.
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