A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Stopped early · Phase 1/Phase 2
Conditions studied: Non-Hodgkin's Lymphoma
In brief
This is a open-label, multicenter, non-randomized, study to evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is designed to further assess the safety and efficacy of obinutuzumab in combination with idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.
Key facts
- Study ID
- NCT02624986
- Run by
- Hoffmann-La Roche
- People needed
- 25
- Starts
- 2015-12-23
- Expected to finish
- 2019-05-20
- Last updated by the study team
- 2020-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histologically documented cluster of differentiation (CD) 20-positive B-cell lymphoma classified as relapsed or refractory FL or DLBCL after treatment with at least two prior chemoimmunotherapy regimens that included an anti-CD20 monoclonal antibody (mAb) and for which no other more appropriate treatment option exists
- At least one bidimensionally measurable lesion
- Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
You may not qualify if…
- Known CD20-negative status at relapse or progression
- Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
- Current use of systemic corticosteroids greater than (>) 20 mg prednisone per day (or equivalent), or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
- Requirement for chronic anticoagulation
- Central nervous system (CNS) disease
- Active infection
- Positive for human immunodeficiency virus (HIV) or hepatitis B or C
- Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1
- Poor hematologic, renal, or hepatic function
- Pregnant or lactating women
- History of progressive multifocal leukoencephalopathy (PML)
Where it is running
- Mayo Clinic Arizona — Phoenix, Arizona, United States
- University of Colorado — Aurora, Colorado, United States
- Norton Medical Plaza II — Louisville, Kentucky, United States
- Swedish Cancer Institute — Cary, North Carolina, United States
- Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
- Guthrie Clinic — Sayre, Pennsylvania, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Prince of Wales Hospital — Randwick, New South Wales, Australia
- Westmead Hospital — Westmead, New South Wales, Australia
- Linear Clinical Research Limited — Nedlands, Western Australia, Australia
- Zentralklinikum Augsburg — Augsburg, Germany
- Charité Research Organisation GmbH Campus-Virchow-Klinikum — Berlin, Germany
- Universitätsklinikum Köln — Cologne, Germany
- SLK-Kliniken Heilbronn GmbH — Heilbronn, Germany
- Universitätsklinikum Wurzburg — Würzburg, Germany
- North Shore Hospital — Auckland, New Zealand
- Christchurch Hospital — Christchurch, New Zealand
- Auckland Clinical Studies Limited — Grafton, New Zealand
- Keimyung University Dongsan Medical Center — Daegu, South Korea
- National Cancer Center — Gyeonggi-do, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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