Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma (BVB)

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: Brentuximab Vedotin; Drug: B-CAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02191930

Uni-Koeln-1707

Details and patient eligibility

About

The purpose of this trial is to determine

1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy
2. Progression-free survival (PFS) 3 years after registration

Enrollment: 70 patients

Sex: All

Ages: 60 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (B-CAP):

• classical Hodgkin Lymphoma
• Age 60 years or older
• ECOG performance status ≤ 2 or ≤ 3 if due to HL
• CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat)
• Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
• written informed consent

Exclusion Criteria (B-CAP):

• Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
• Prior chemotherapy or radiation for HL except prephase
• Peripheral neuropathy greater than CTC Grade 1

Inclusion Criteria (BV only):

• classical Hodgkin Lymphoma
• Age 60 years or older
• stage IA to IVB
• CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat)
• Patients not eligible to curative poly-chemotherapy at the investigators judgment
• written informed consent

Exclusion Criteria (BV only):

• Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
• Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
• Peripheral neuropathy greater than CTC Grade 1

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

B-CAP

Experimental group

Description:

Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days

Treatment:

Drug: B-CAP

Brentoximab Vedotin only

Experimental group

Description:

Patients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days

Treatment:

Drug: Brentuximab Vedotin