Education and Training
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.
The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.
The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: brentuximab vedotin
- drug: brentuximab vedotin
- drug: rituximab
- drug: vincristine
- drug: cyclophosphamide
- drug: prednisone
- drug: doxorubicin
Eligibility
Inclusion Criteria:
- Treatment-naive patients with systemic de novo or transformed diffuse large B cell
lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
- International Prognostic Index (IPI) score greater than or equal to 3 for patients
greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients
less than or equal to 60 years of age
- Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Patients in Parts 2 and 3 must have histologically confirmed diagnosis of
CD30-positive DLBCL
Exclusion Criteria:
- Previous history of treated indolent lymphoma
- History of another primary malignancy that has not been in remission for 3 years
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting