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Closed (no longer recruiting)Last updated: 22 January 2024

Inharmony: This phase I/II trial is combining four drugs with standard CHOP chemotherapy for the treatment of Follicular Lymphoma and Diffuse Large Cell LymphomaA Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Diffuse Large B-Cell Lymphoma

Clinical summary

Summary

his study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab plus bendamustine (MPDL-G-benda) in participants with follicular lymphoma (FL) or obinutuzumab plus cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) (MPDL-G-CHOP) in participants with FL or diffuse large B-cell lymphoma (DLBCL), followed by post-induction treatment consisting of either atezolizumab plus obinutuzumab (MPDL-G) in participants with FL who achieve a complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab alone in participants with DLBCL who achieve a CR at EOI.

Conditions

This trial is treating patients with Follicular Lymphoma,Diffuse Large Cell Lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

Inharmony

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Diffuse Large B-Cell Lymphoma

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • For participants enrolled in the safety run-in phase: lymphoma classified as either relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen or previously untreated Grade 1, 2, or 3a FL that requires treatment
  • For participants enrolled in the expansion phase: lymphoma classified as either previously untreated Grade 1, 2, or 3a FL that requires treatment or previously untreated advanced DLBCL
  • Histologically documented cluster of differentiation 20 (CD20) positive lymphoma
  • Fluorodeoxyglucose-avid lymphoma
  • At least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging)
  • Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL
  • For women who are not postmenopausal or surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than [<] 1 percent [%] per year during the treatment period and for at least 18 months after the last dose of study treatment for participants in the Atezo-G-benda and Atezo-G-CHOP treatment groups or for at least 12 months after the last dose of study treatment for participants in the Atezo-R-CHOP treatment group
  • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm

Exclusion

  • Histological evidence of transformation of FL into high-grade B-cell non-Hodgkin's lymphoma (NHL)
  • Central nervous system lymphoma or leptomeningeal infiltration
  • For participants with DLBCL: preplanned consolidative radiotherapy
  • Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
  • For participants with relapsed or refractory FL: prior allogeneic or autologous stem cell transplantation, anthracycline therapy, treatment with fludarabine or alemtuzumab within 12 months prior to Day 1 of Cycle 1, treatment with a monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1, radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
  • History of solid organ transplantation
  • History of severe allergic or anaphylactic reaction or known sensitivity to humanized or murine monoclonal antibodies
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab, obinutuzumab, rituximab, or bendamustine formulation, including mannitol
  • Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
  • History of progressive multifocal leukoencephalopathy
  • Vaccination with a live virus vaccine within 28 days prior to Day 1 of Cycle 1
  • History of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
  • Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1, or anticipation of a major surgical procedure during the course of the study
  • For participants who will be receiving CHOP: left ventricular ejection fraction (LVEF) <50% by multiple-gated acquisition (MUGA) scan or echocardiogram
  • Inadequate hematologic, renal, and liver function (unless due to underlying lymphoma)

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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