Trials / Completed
CompletedNCT03133221
1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation
1630GCC: A Pilot Study of Zydelig in Patients With B-cell Malignancies as Post-Autologous Transplant Remission Maintenance
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot study to learn how safe and how effective the study drug Zydelig works, after autologous stem cell transplant as a maintenance therapy in patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL).
Detailed description
This pilot study is focused on maintenance Zydelig for patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL) after autologous stem cell transplantation. Oral Zydelig at 150 mg (or adjusted dose) twice daily continuously on 28-day cycles. Patients will continue on Zydelig up to one year or to progression/relapse/death or unacceptable toxicity, whichever occurs first.
Conditions
- Non Hodgkin Lymphoma
- Follicular Lymphoma
- Indolent Lymphoma
- B-cell Lymphoma
- Transformed Lymphoma
- Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
- Small Lymphocytic Lymphoma
- Lymphoplasmacytic Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zydelig | Zydelig given at 150mg continuously in 28-day cycles |
Timeline
- Start date
- 2017-10-23
- Primary completion
- 2023-06-15
- Completion
- 2024-09-29
- First posted
- 2017-04-28
- Last updated
- 2025-06-27
- Results posted
- 2024-09-19
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03133221. Inclusion in this directory is not an endorsement.