HD21 for Advanced Stages

University of Cologne

Status and phase: Active, not recruiting; Phase 3

Conditions: Classical Hodgkin Lymphoma

Treatments: Drug: Brentuximab Vedotin; Drug: Cyclophosphamide; Drug: Dexamethasone; Drug: Doxorubicin; Drug: Bleomycin; Drug: Dacarbazine; Drug: Etoposide; Drug: Procarbazine; Drug: Vincristine; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02661503

2014-005130-55 (EudraCT Number)

Uni-Koeln-1762

Details and patient eligibility

About

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective).

If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).

Enrollment: 1,500 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven classical Hodgkin lymphoma
• First diagnosis, no previous treatment, 18 to 60 years of age
• Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

Exclusion criteria

• Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
• Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
• Prior chemotherapy or radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

BEACOPP

Active Comparator group

Description:

4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.

Treatment:

Drug: Vincristine

Drug: Prednisone

Drug: Procarbazine

Drug: Doxorubicin

Drug: Bleomycin

Drug: Cyclophosphamide

Drug: Etoposide

BRECADD

Experimental group

Description:

4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.

Treatment:

Drug: Doxorubicin

Drug: Dexamethasone

Drug: Cyclophosphamide

Drug: Etoposide

Drug: Dacarbazine

Drug: Brentuximab Vedotin