Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

Conditions: Advanced Classical Hodgkin Lymphoma
MedDRA version: 15.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-005450-60-ES

Lead Sponsor: Millennium Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1040

Inclusion Criteria

? Treatment-naïve
? Histologically confirmed classical HL
? ECOG performance status ? 2
? Bidimensional measurable disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 832
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 208

Exclusion Criteria

? Nodular lymphocyte predominant Hodgkin lymphoma
? Cerebral/meningeal disease, including signs and symptoms of PML
? Pulmonary diffusion capacity > 25% lower than normal predicted value
? Sensory or motor peripheral neuropathy
? Known human immunodeficiency virus (HIV) positive
? Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Modified progression free survival (mPFS) per independent review facility (IRF);Secondary Objective: Overall survival rate;Primary end point(s): Modified progression-free survival (PFS) per independent review facility (IRF);Timepoint(s) of evaluation of this end point: ?Screening<br>?After Cycle 2: On C2D25 (± 1 day). This corresponds to 10 days (± 1 day) after the 4th dose (after C2D15) of study drug administration<br>? At End of Treatment Visit, following last dose of frontline therapy (usually Cycle 6): 30 ± 7 days following last dose of frontline therapy. In addition, patients who switch therapy prior to completion of frontline therapy must have a scan performed prior to the first dose of alternative treatment.<br>?During the follow-up period: every 3 months for the first year and then every 6 months thereafter.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: ? Screening <br>? Days 1 & 15 of each treatment cycle (safety endpoints) <br>? Day 1 of each treatment cycle and Days 8 & 15 of Cycles 1 & 3 (PK endpoints) <br>? Day 1 of treatment cycles 1, 2 & 6 (antibodies endpoint) <br>? After Cycle 2: On C2D25 (± 1 day). This corresponds to 10 days (± 1 day) after the 4th dose (after C2D15) of study drug administration<br>? At End of Treatment Visit, following last dose of frontline therapy (usually Cycle 6): 30 +/- 7 days following last dose of frontline therapy. In addition, patients who switch therapy prior to completion of frontline therapy must have a scan performed prior to the first dose of alternative treatment.<br>? During the follow-up period: every 3 months for the first year and then every 6 months thereafter.