A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

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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

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

Exclusion criteria

  • Nodular lymphocyte predominant Hodgkin lymphoma.
  • Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
  • Sensory or motor peripheral neuropathy.
  • Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
  • Known human immunodeficiency virus (HIV) positive.
  • 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)

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

Trial documents
2

Trial contacts and locations

216

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Data sourced from clinicaltrials.gov

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