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Eine Studie zu Idasanutlin in Kombination mit Obinutuzumab bei Teilnehmenden mit rezidivierendem/refraktärem (R/R) follikulärem Lymphom (FL) und in Kombination mit Rituximab in R/R diffusem großem B-Zell-Lymphom (DLBCL)
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
- Krebs
- Non-Hodgkin-Lymphom
- Diffuses großzelliges B-Zell-Lymphom
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Beendet
Diese Studie läuft in
Städte
- Augsburg
- Berlin
- Heilbronn
- Köln
- Würzburg
Studien-ID:
NCT02624986 2015-002100-83 BH29812
Studienzusammenfassung
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.
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT02624986,BH29812,2015-002100-83
Studien-ID
Idasanutlin, Obinutuzumab, Rituximab
Treatments
Non-Hodgkin's Lymphoma
Condition
Official Title
A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Einschlusskriterien
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
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