NL-OMON45171CompletedNot Applicable
A Phase Ib/II, open label study evaluating the safery and pharmacokinetics of GDC-0199 (ABT-199) in combination with Rituximab (R) or Obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with B Cell non-hodgkin's lymphoma (NHL) and DLBCL - GO27878 studie - for patients with Non-Hodgkin's Lymphoma
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 21
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •General Inclusion Criteria:
- •- Patients, age ><= 18 years
- •- At least one bi-dimensionally measurable lesion defined as >1.5 cm in its longest dimension
- •- Ability and willingness to comply with the study protocol procedures
- •- Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
- •- ECOG performance status of 0, 1, or 2
- •- Adequate hematologic function
- •- For female patients of childbearing potential and male patients with female partners of childbearing potential, agreement to use highly effective forms of contraception ;Dose Escalation Portion of the Study:
- •- Patients must have histologically confirmed B-cell non-Hodgin's Lymphoma (NHL)
- •- Patients must have never received previous R-CHOP treatment
- •- Any relapsed/refractory patients that are enrolled during the dose escalation should have received only a single previous treatment regimen;Expansion Portion of the Study:
- •- Patients must have previously-untreated diffuse large, B-cell lymphoma
- •- International prognostic index (IPI) score must be 2-5
Exclusion Criteria
- •General Exclusion Criteria:
- •- Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
- •- Primary CNS lymphoma
- •- Vaccination with live vaccines within 28 days prior to randomization
- •- History of other malignancy that could affect compliance with the protocol or interpretation of results
- •- Evidence of significant, concomitant disease or illness
- •- Use of CYP3A inhibitors or inducers within 7 days of the first dose of venetoclax
- •- Requires use of Warfarin
- •- Recent major surgery
- •- Women must not be pregnant or breastfeeding;Dose Escalation Portion of the Study:
- •- Prior anthracycline therapy
- •- Chemotherapy or other investigational therapy within 5 half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1
- •- histologically confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL);Expansion Portion of the Study:
- •- Patients with transformed lymphoma
- •- Prior therapy for non-hodgkin's lymphoma (NHL)
- •- Current Grade > 1 peripheral neuropathy
Investigators
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