CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Ibrutinib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed DLBCL or transformed DLBCL
  • ✓Relapsed or refractory DLBCL after prior systemic therapy, post-transplant relapse, or ineligible/unsuitable for transplant
  • ✓Measurable (≥1.5 cm) or evaluable disease on imaging
  • ✓ANC ≥1.0 × 10⁹/L
Key exclusion· 9
  • ✕Cancer therapy within 7 days of treatment start (14 days for palliative radiation, 5 half-lives for oral therapy)
  • ✕Active HBV, HCV, or HIV infection
  • ✕Primary CNS involvement only
  • ✕Autologous stem cell transplant within 3 months or allogeneic within 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02874404
NCT02874404Phase 2Completed
CompareCT.gov

A Single-Center Phase IIa Study Evaluating the Safety and Tolerability of TGR-1202 and Ibrutinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Trial of the Lymphoma Precision Medicine Laboratory

University of Nebraska·interventional·Posted Aug 22, 2016·Updated Oct 5, 2023

In Brief

A Phase 2 clinical trial evaluating Ibrutinib, Laboratory Biomarker Analysis, and 1 other intervention for Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement or does not respond to treatment. TGR-1202 and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 22, 2016
Enrollment StartOct 7, 2016
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.9 years ago

Interventions

Ibrutinibdrug

Given PO

Laboratory Biomarker Analysisother

Correlative markers

PI3K-delta Inhibitor TGR-1202drug

Given PO