NCT01777152

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT01777152

Principal Investigator:

Study Type:

INTERVENTIONAL

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Anaplastic Large-Cell Lymphoma

Non-Hodgkin Lymphoma

T-Cell Lymphoma

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: brentuximab vedotin
- Description: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
- Arm Group Labels: A+CHP
- Type: DRUG
- Name: doxorubicin
- Description: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
- Arm Group Labels: A+CHP, CHOP
- Type: DRUG
- Name: prednisone
- Description: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
- Arm Group Labels: A+CHP, CHOP
- Type: DRUG
- Name: vincristine
- Description: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
- Arm Group Labels: CHOP
- Type: DRUG
- Name: cyclophosphamide
- Description: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
- Arm Group Labels: A+CHP, CHOP

Sponsor

Seagen Inc.