A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

Takeda

Status and phase: Active, not recruiting; Phase 3

Conditions: Hodgkin Lymphoma

Treatments: Drug: brentuximab vedotin; Drug: bleomycin; Drug: doxorubicin; Drug: dacarbazine; Drug: vinblastine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712490

2023-506419-16 (Other Identifier)

C25003

JapicCTI-142491 (Registry Identifier)

C25003CTID (Other Identifier)

U1111-1161-4937 (Registry Identifier)

12/LO/1950 (Registry Identifier)

2011-005450-60 (EudraCT Number)

REec-2013-0114 (Registry Identifier)

1025002760 (Registry Identifier)

Details and patient eligibility

About

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)

Enrollment: 1,334 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.
2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
4. Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.

Exclusion criteria

1. Nodular lymphocyte predominant Hodgkin lymphoma.
2. Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
3. Sensory or motor peripheral neuropathy.
4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
5. Known human immunodeficiency virus (HIV) positive.
6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.

Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,334 participants in 2 patient groups

A + AVD

Experimental group

Description:

A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.

Treatment:

Drug: vinblastine

Drug: dacarbazine

Drug: doxorubicin

Drug: brentuximab vedotin

ABVD

Active Comparator group

Description:

ABVD consists of doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.

Treatment:

Drug: vinblastine

Drug: dacarbazine

Drug: doxorubicin

Drug: bleomycin