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NCT04209621 · ClinicalTrials.gov registry record · Phase 2
Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04209621 is a Phase 2 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 3 participants.
The verdict
NCT04209621, a Phase 2 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers often treated with the drug ibrutinib. For some people, ibrutinib stops working. Researchers want to see if adding another drug can help. Objective: To test how people with ibrutinib-resistant CLL respond to duvelisib. Eligibility: People ages 18 and older with CLL or SLL that is no longer responding to ibrutinib or has developed mutations that could stop it from working Design: Participants will be screened with: * Medical history * Physical exam * Heart tests * Blood and urine tests * CT scan. For this, participants will have a dye injected into a vein. They will lie in a machine that takes pictures of the body. * Bone marrow biopsy. For this, a needle injected into the participant s bone will remove marrow. * Optional lymph node biopsy. For this, the participants whole lymph node or part of it will be removed through the skin. * Optional lymphapheresis. For this, the participants blood is removed through a vein in one arm, the white blood cells separated out, and the blood returned through a vein in the other arm. Participants will take duvelisib twice daily by mouth. They will continue ibrutinib at their current dose for the first 6 months. They will continue to take duvelisib until their CLL/SLL stops responding or they develop intolerable side effects. Participants will take an antibiotic and antiviral medication. They may take steroids. Participants will have blood tests every 2 weeks during the first 2 months. Participants will have monthly follow-up visits during the first 6 months and every 3 months thereafter. These will include repeats of some of the screening tests.
Interventions
- DRUG Duvelisib
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2021-01-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04209621
The ClinicalTrials.gov registry entry for NCT04209621 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Duvelisib is the first listed.
NCT04209621 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04209621 about?
NCT04209621 is a clinical study titled "Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma". Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers often treated with the drug ibrutinib. For some people, ibrutinib stops working. Researchers want to see if adding another drug can help. Objective: To test how people with ibrutinib-resistant CLL resp...
What is the current status of trial NCT04209621?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2020-07-31. Estimated completion is 2021-01-22.
What interventions are being tested in trial NCT04209621?
The interventions under investigation include: Duvelisib (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT04209621?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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