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 (ECHELON-2)
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ClinicalTrials.gov Identifier: NCT01777152 |
Recruitment Status :
Active, not recruiting
First Posted : January 28, 2013
Results First Posted : July 30, 2019
Last Update Posted : December 23, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anaplastic Large-Cell Lymphoma Non-Hodgkin Lymphoma T-Cell Lymphoma | Drug: brentuximab vedotin Drug: doxorubicin Drug: prednisone Drug: vincristine Drug: cyclophosphamide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 452 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | August 15, 2018 |
Estimated Study Completion Date : | August 15, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
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Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles Drug: prednisone 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles Drug: vincristine 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles Drug: cyclophosphamide 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles |
Experimental: A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
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Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
Other Name: Adcetris; SGN-35 Drug: doxorubicin 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles Drug: prednisone 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles Drug: cyclophosphamide 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles |
- Progression-free Survival Per Independent Review Facility (IRF) [ Time Frame: Up to 60 months ]
- Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) [ Time Frame: Up to 60 months ]
- Complete Remission Rate Per IRF at End of Treatment (EOT) [ Time Frame: Up to 8.34 months ]Number of patients who achieved complete remission (CR) at EOT
- Overall Survival [ Time Frame: Until death or study closure, up to 7 years post-treatment ]
- Objective Response Rate Per IRF at End of Treatment [ Time Frame: Up to 8.34 months ]Number of patients who achieved CR or partial response (PR) at EOT
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 8.28 months ]
- Incidence of Laboratory Abnormalities [ Time Frame: Up to 8.28 months ]Number of patients who experienced a Grade 3 or higher laboratory toxicity

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777152

Study Director: | Thomas Manley, MD | Seagen Inc. |
Documents provided by Seagen Inc.:
Responsible Party: | Seagen Inc. |
ClinicalTrials.gov Identifier: | NCT01777152 |
Other Study ID Numbers: |
SGN35-014 2012-002751-42 ( EudraCT Number ) |
First Posted: | January 28, 2013 Key Record Dates |
Results First Posted: | July 30, 2019 |
Last Update Posted: | December 23, 2019 |
Last Verified: | December 2019 |
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 |
Lymphoma Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Prednisone Cyclophosphamide Doxorubicin Vincristine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents Glucocorticoids |