TriangleNCT01777152 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2021-11-30
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-free Survival Per Independent Review Facility (IRF)
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
Overall Survival (OS)
Objective Response Rate (ORR) Per IRF at End of Treatment
Incidence of Adverse Events (AEs)
Incidence of Laboratory Abnormalities
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- cyclophosphamide, doxorubicin, vincristine, and prednisone
- intervention Names
- Drug: doxorubicin
- Drug: prednisone
- Drug: vincristine
- Drug: cyclophosphamide
- label
- CHOP
- type
- ACTIVE_COMPARATOR
- description
- brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
- intervention Names
- Drug: brentuximab vedotin
- Drug: doxorubicin
- Drug: prednisone
- Drug: cyclophosphamide
- label
- A+CHP
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- A+CHP
- description
- 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
- name
- brentuximab vedotin
- other Names
- Adcetris; SGN-35
- type
- DRUG
- arm Group Labels
- A+CHP
- CHOP
- description
- 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
- name
- doxorubicin
- type
- DRUG
- arm Group Labels
- A+CHP
- CHOP
- description
- 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
- name
- prednisone
- type
- DRUG
- arm Group Labels
- CHOP
- description
- 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
- name
- vincristine
- type
- DRUG
- arm Group Labels
- A+CHP
- CHOP
- description
- 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
- name
- cyclophosphamide
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 452
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- measure
- Progression-free Survival Per Independent Review Facility (IRF)
- time Frame
- Up to 60 months
- secondary Outcomes
- 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.
- measure
- Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
- time Frame
- Up to 60 months
- 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.
- measure
- Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
- time Frame
- Up to 8.34 months
- description
- The time from randomization to death due to any cause.
- measure
- Overall Survival (OS)
- time Frame
- Up to 90 months
- 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.
- measure
- Objective Response Rate (ORR) Per IRF at End of Treatment
- time Frame
- Up to 8.34 months
- 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.
- measure
- Incidence of Adverse Events (AEs)
- time Frame
- Up to 8.28 months
- description
- Number of participants who experienced a Grade 3 or higher laboratory toxicity.
- measure
- Incidence of Laboratory Abnormalities
- time Frame
- Up to 8.28 months
Full study description
- 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.
Source references
- references
- citation
- Iyer S, Mehta-Shah N, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Alpdogan O, Feldman TA, Camus V, Gritti G, Zinzani PL, Belada D, Mayer J, Choi I, Cheong JW, Rustia E, Fenton K, Fanale M, Savage KJ, Horwitz SM. Association of PET4 response with outcomes of BV-CHP vs CHOP in the ECHELON-2 trial in CD30+ peripheral T-cell lymphoma. Blood Adv. 2025 Dec 9;9(23):5976-5987. doi: 10.1182/bloodadvances.2024015282.
- pmid
- 40829107
- type
- DERIVED
- citation
- Domingo-Domenech E, Pro B, Illidge T, Horwitz S, Trumper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Kim WS, Feldman T, Choi I, Gritti G, Belada D, Shustov A, Illes A, Zinzani PL, Huttmann A, Trneny M, Le Gouill S, Jagadeesh D, Friedberg JW, Little M, Dong C, Fanale M, Fenton K, Savage KJ. Brentuximab vedotin plus chemotherapy for the treatment of front-line systemic anaplastic large cell lymphoma: subgroup analysis of the ECHELON-2 study at 5 years' follow-up. Blood Cancer J. 2025 Aug 1;15(1):129. doi: 10.1038/s41408-025-01329-2.
- pmid
- 40750774
- type
- DERIVED
- citation
- Savage KJ, Horwitz SM, Advani R, Christensen JH, Domingo-Domenech E, Rossi G, Morschhauser F, Alpdogan O, Suh C, Tobinai K, Shustov A, Trneny M, Yuen S, Zinzani PL, Trumper L, Ilidge T, O'Connor OA, Pro B, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Iyer S. Role of stem cell transplant in CD30+ PTCL following frontline brentuximab vedotin plus CHP or CHOP in ECHELON-2. Blood Adv. 2022 Oct 11;6(19):5550-5555. doi: 10.1182/bloodadvances.2020003971.
- pmid
- 35470385
- type
- DERIVED
- citation
- Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illes A, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Huttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trumper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi: 10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4.
- pmid
- 30522922
- type
- DERIVED
- citation
- Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
- pmid
- 25135998
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- omized Clinical Trial in Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas (Study 6: ECHELON-2, NCT01777152) The efficacy of ADCETRIS in combination with chemotherapy for the treatment of adult patients with previously untreated, CD30-expressing PTCL was evaluated in
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Preserved source evidence · Not medical advice