EUCTR2013-003749-40-AT
Active, not recruiting
Phase 1
A Phase Ib/II, open label study evaluating the safety 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
ConditionsB-cell non-hodgkin's lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL)MedDRA version: 20.0 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10029601 Term: Non-Hodgkin's lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10029600 Term: Non-Hodgkin's lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- B-cell non-hodgkin's lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL)
- Sponsor
- F. Hoffmann- La Roche Ltd.
- Enrollment
- 264
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General Inclusion Criteria:
- •\- Patients, age \>\= 18 years
- •\- At least one bi\-dimensionally measurable lymphoma lesion defined as
- •\> 1\.5 cm in its longest dimension which is also FDG avid by screening
- •\- 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
Exclusion Criteria
- •General Exclusion Criteria:
- •\- Contraindication to receive any of the individual components of CHOP,
- •rituximab or obinutuzumab
- •\- CNS lymphoma or primary mediastinal DLBCL
- •\- 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
- •\- Recent major surgery
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not 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 DLBCNon-Hodgkin's Lymphoma10025320NL-OMON45171Hoffmann-La Roche21
Active, not recruiting
Phase 1
A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's LymphomaEUCTR2013-003749-40-CZF. Hoffmann- La Roche Ltd.264
Active, not recruiting
Phase 1
A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's LymphomaEUCTR2013-003749-40-HUF. Hoffmann- La Roche Ltd.264
Active, not recruiting
Phase 1
A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's LymphomaEUCTR2013-003749-40-ESRoche Farma, S.A. en nombre de F. Hoffmann- La Roche Ltd.264
Active, not recruiting
Phase 1
A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's LymphomaB-cell non-hodgkin's lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL)MedDRA version: 18.1Level: PTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029601Term: Non-Hodgkin's lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-003749-40-NLF. Hoffmann- La Roche Ltd.264