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NCT03147885 · ClinicalTrials.gov registry record · Phase 1
Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and Recurrent Mantle Cell Lymphoma, sponsored by Barbara Ann Karmanos Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT03147885: Active Phase 1 study of Diffuse Large B Cell Lymphoma and Recurrent Mantle Cell Lymphoma, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT03147885 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Recurrent Mantle Cell Lymphoma that is active but no longer recruiting, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 43 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03147885, a Phase 1 study of Diffuse Large B Cell Lymphoma and Recurrent Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by Barbara Ann Karmanos Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor (selective inhibitor of nuclear export) in combination with standard therapy for B cell Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose of Selinexor in combination with RCHOP and also study the efficacy of this combination for therapy of B cell Non-Hodgkin's lymphoma. Giving Selinexor plus chemotherapy may work better in treating patients with B cell non-Hodgkin lymphoma.
Primary Outcome
Toxicity grading in both phase 1b and phase 2 parts will be done based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 guidelines. Toxicity data will be collected at least weekly during the course of treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Conditions Studied
Interventions
- DRUG Selinexor
Study Locations (1)
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2017-06-20 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What the registry record for NCT03147885 still lists
NCT03147885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (80% lower).
The record links to 10 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Selinexor is the first listed.
NCT03147885 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03147885 about?
NCT03147885 is a clinical study titled "Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma". This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor (selective inhibitor of nuclear export) in combination with standard therapy for B cell Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose of Selinexor in combination with...
What is the current status of trial NCT03147885?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2017-06-20. Estimated completion is 2027-12.
What conditions does trial NCT03147885 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Follicular Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03147885?
The interventions under investigation include: Selinexor (DRUG).
Who is sponsoring clinical trial NCT03147885?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03147885 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03147885's enrollment target sits among peer trials
43 66th of 114 higher than 48 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B 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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