Brief Summary
This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.
Brief Title
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Completion Date
Completion Date Type
Actual
Conditions
Anaplastic Large-Cell Lymphoma
Non-Hodgkin Lymphoma
T-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
* Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion Criteria:
* History of another primary invasive malignancy that has not been in remission for at least 3 years
* Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
* History of progressive multifocal leukoencephalopathy (PML)
* Cerebral/meningeal disease related to the underlying malignancy
* Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion Criteria:
* History of another primary invasive malignancy that has not been in remission for at least 3 years
* Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
* History of progressive multifocal leukoencephalopathy (PML)
* Cerebral/meningeal disease related to the underlying malignancy
Inclusion Criteria
Inclusion Criteria:
* Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Gender
All
Gender Based
false
Keywords
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Lymphoma
Monomethyl auristatin E
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01777152
Org Class
Industry
Org Full Name
Seagen Inc.
Org Study Id
SGN35-014
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Primary Outcomes
Outcome Description
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Outcome Measure
Progression-free Survival Per Independent Review Facility (IRF)
Outcome Time Frame
Up to 60 months
Secondary Ids
Secondary Id
2012-002751-42
Secondary Outcomes
Outcome Description
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Outcome Time Frame
Up to 60 months
Outcome Measure
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
Outcome Description
The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Outcome Time Frame
Up to 8.34 months
Outcome Measure
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
Outcome Description
The time from randomization to death due to any cause.
Outcome Time Frame
Up to 90 months
Outcome Measure
Overall Survival (OS)
Outcome Description
The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Outcome Time Frame
Up to 8.34 months
Outcome Measure
Objective Response Rate (ORR) Per IRF at End of Treatment
Outcome Description
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Outcome Time Frame
Up to 8.28 months
Outcome Measure
Incidence of Adverse Events (AEs)
Outcome Description
Number of participants who experienced a Grade 3 or higher laboratory toxicity.
Outcome Time Frame
Up to 8.28 months
Outcome Measure
Incidence of Laboratory Abnormalities
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ioannis Mantzaris
Investigator Email
IMANTZAR@montefiore.org
Investigator Phone
Categories Mesh Debug
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
LYMPHOMA, LARGE-CELL, ANAPLASTIC
LYMPHOMA, NON-HODGKIN
LYMPHOMA, T-CELL
HEMATOLOGIC DISEASES
LYMPHOMA
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
HEMIC AND LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
BRENTUXIMAB VEDOTIN
DOXORUBICIN
PREDNISONE
VINCRISTINE
CYCLOPHOSPHAMIDE
OLIGOPEPTIDES
PEPTIDES
AMINO ACIDS, PEPTIDES, AND PROTEINS
ANTIBODIES, MONOCLONAL, HUMANIZED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
SERUM GLOBULINS
GLOBULINS
DAUNORUBICIN
ANTHRACYCLINES
NAPHTHACENES
POLYCYCLIC AROMATIC HYDROCARBONS
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
ORGANIC CHEMICALS
POLYCYCLIC COMPOUNDS
AMINOGLYCOSIDES
GLYCOSIDES
CARBOHYDRATES
PREGNADIENEDIOLS
PREGNADIENES
PREGNANES
STEROIDS
FUSED-RING COMPOUNDS
VINCA ALKALOIDS
SECOLOGANIN TRYPTAMINE ALKALOIDS
INDOLE ALKALOIDS
ALKALOIDS
HETEROCYCLIC COMPOUNDS
INDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
INDOLIZIDINES
INDOLIZINES
PHOSPHORAMIDE MUSTARDS
NITROGEN MUSTARD COMPOUNDS
MUSTARD COMPOUNDS
HYDROCARBONS, HALOGENATED
PHOSPHORAMIDES
ORGANOPHOSPHORUS COMPOUNDS