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 DLBC

Completed

• Conditions: Non-Hodgkin's Lymphoma; 10025320

• Registration Number: NL-OMON45171
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified