Trials / Withdrawn
WithdrawnNCT04694560
A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
A Phase 2 Time-Limited Approach to Front-Line Ibrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Achieve Complete Remission or Partial Remission With Undetectable Minimal Residual Disease
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to find out whether people with CLL or SLL who are currently receiving treatment with ibrutinib can stop treatment and remain off-treatment for at least 12 months, if they have achieved complete or partial remission of their disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Treatment Free Observation | Participants without evidence of clinical relapse will remain off therapy and continue serial monitoring through end of study at 24 cycles. Participants with clinical relapse will continue to be monitored off therapy through 24 cycles or until meeting criteria for treatment per iwCLL criteria. If participants experience clinical relapse requiring treatment, radiology assessment, disease assessment, and testing for resistance mutations will be performed. Participants will be observed for an additional 12 cycles following start of reintroduction of therapy. |
Timeline
- Start date
- 2020-12-22
- Primary completion
- 2023-03-06
- Completion
- 2023-03-06
- First posted
- 2021-01-05
- Last updated
- 2025-05-16
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04694560. Inclusion in this directory is not an endorsement.