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

Sponsor

University of Cologne (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02191930

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to determine

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
Progression-free survival (PFS) 3 years after registration

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Drug: B-CAP Drug: Brentuximab Vedotin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B-CAP 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	Drug: B-CAP Other Names: Brentuximab Vedotin Cyclophosphamide Doxorubicine Predniso(lo)ne
Experimental: Brentoximab Vedotin only 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	Drug: Brentuximab Vedotin

Arm

Intervention/Treatment

Experimental: B-CAP

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

Drug: B-CAP

Other Names:

Brentuximab Vedotin

Cyclophosphamide

Doxorubicine

Predniso(lo)ne

Experimental: Brentoximab Vedotin only

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

Drug: Brentuximab Vedotin

Outcome Measures

Primary Outcome Measures

Objective response rate [after 6 cycles of therapy (at least 18 weeks after start of treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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