Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Gray Zone Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).

Cycle 1:

Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)

Cycles 2-6:

Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg

brentuximab vedotin

Jakub Svoboda, MD

This is a Phase I/II multicenter single arm non-randomized open label study of the investigational drug, brentuximab vedotin, given in combination with routine chemotherapy (rituximab, cyclophosphamide, doxorubicin and prednisone) every 3 weeks for a total of 6 cycles.

Brentuximab Vedotin and Chemotherapy in CD30+ PMBL, Diffuse Large B-Cell, and Grey Zone Lymphoma Patients

A Phase I/II Study Of Brentuximab Vedotin In Combination With Multi-Agent Chemotherapy As Front-Line Treatment In Patients With CD30 Positive Primary Mediastinal Large B-Cell, Diffuse Large B-Cell, And Grey Zone Lymphomas

Dose-limiting toxicity (DLT) is any grade 3 or 4 new non-hematologic toxicity occurring during Cycle 1 requiring a dose delay of \>14 days from the planned Day 1 of Cycle 2 (21 days from Day 1 of Cycle 1). The initial planned dose of brentuximab vedotin for the Phase I cohort of 6 patients is 1.8 mg/kg. This cohort will be evaluated for DLT in the first cycle of treatment. Dose de-escalation to 1.2 mg/kg will occur if ≥ 2 of 6 patients at the 1.8 mg/kg dose level experience a DLT.

Overall response rate (ORR) is defined as the proportion of patients with CR or PR according to the International Working Group Response Criteria for non-Hodgkin Lymphoma at the conclusion of systemic therapy.

Abramson Cancer Center at Penn Medicine

Phase I/II

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Lymphoma subtype

A total of 6 subjects were evaluated for dose limiting toxicities during Phase I. Since no DLTs were observed, the Phase I subjects were included in the efficacy analysis as they received the same dose of brentuximab vedotin 1.8 mg/kg as the Phase II subjects.

Number of Subjects With Dose-limiting Toxicities

32 patients were enrolled: 1 patient withdrew, 1 was removed for protocol non-compliance, 1 was removed due to regimen violation; a total of 29 were evaluable for efficacy.

Overall Response Rate (ORR)

Overall Study

Spots Global Cancer Trial Database for Brentuximab Vedotin and Chemotherapy in CD30+ PMBL, Diffuse Large B-Cell, and Grey Zone Lymphoma Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial