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Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

NCT04209621 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-03-09

Study results available
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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.

Conditions

  • Small Lymphocytic Leukemia (SLL)
  • Chronic Lymphocytic Leukemia (CLL)

Interventions

DRUG

Duvelisib

twice daily as tolerated until disease progression

DRUG

Ibrutinib

daily for the first six 28-day cycles

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Clare C Sun, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2021-01-22
Completion
2021-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04209621 on ClinicalTrials.gov