Clinical Trials /

CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1.

NCT03217643

Description:

It has been recently reported that EATL type 1, but not refractory coeliac disease, strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the combination brentuximab vedotin and CHP is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment of EATL.

Related Conditions:
  • Enteropathy-Associated T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1.
  • Official Title: Phase 2 Study of Brentuximab Vedotin Associated With CHP Followed by Consolidation With High-dose Therapy / Autologous Stem-cell Transplantation as Frontline Treatment of Patients With Enteropathy-associated T-cell Lymphoma Type 1.

Clinical Trial IDs

  • ORG STUDY ID: IMIS2015-03
  • NCT ID: NCT03217643

Conditions

  • Enteropathy Associated T-cell Lymphoma

Interventions

DrugSynonymsArms
Brentuximab VedotinBrentuximab Vedotin

Purpose

It has been recently reported that EATL type 1, but not refractory coeliac disease, strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the combination brentuximab vedotin and CHP is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment of EATL.

Detailed Description

      Brentuximab vedotin is an anti-CD30 monoclonal antibody conjugated to the cytotoxic drug
      monomethyl auristatin E. It is currently evaluated in combination with multi-agent
      chemotherapy as frontline treatment of systemic ALCL (sALCL) and other CD30-positive mature T
      cell and NK cell lymphomas. Preliminary results of this phase 1 study have been presented at
      the 2012 ASH Annual Meeting: 26 patients have been treated with combination brentuximab
      vedotin and CHP. Nineteen of 26 patients had a diagnosis of sALCL and 7 patients had a
      diagnosis of another mature Tor NK-cell lymphoma (EATL, n=1). The maximum tolerated dose of
      brentuximab vedotin in combination with CHP was not exceeded at 1.8 mg/kg IV. Adverse events
      were manageable. All patients achieved an objective response, with 23 patients (88%)
      achieving a complete response (CR). All 7 non-sALCL patients achieved a CR.

      Finally, it has been recently reported that EATL type 1, but not refractory coeliac disease,
      strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile
      of the combination brentuximab vedotin and CHP is known and since the role of etoposide as
      part of induction regimen is not demonstrated, the investigator will assess the efficacy and
      toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline
      treatment of EATL.
    

Trial Arms

NameTypeDescriptionInterventions
Brentuximab VedotinExperimentalThe first part of the treatment (induction) will evaluate BV-CHP. The second part of the treatment (consolidation) will use standard drugs for the treatment of lymphoma. HDT will consist of BEAM conditioning regimen (or BAM if carmustine is not available). Management of HDT/ASCT will be done according to standard practice.
  • Brentuximab Vedotin

Eligibility Criteria

        Main Inclusion Criteria:

          1. Histologically confirmed diagnosis of EATL based on criteria established by the World
             Health Organization (WHO) 2016 Classification of Tumors of Haematopoietic and Lymphoid
             Tissues.

          2. EATL should be CD30-positive with a threshold of 10%.

          3. Patients aged ≥ 18 years and < 70 years at the time of study entry.

          4. ECOG performance status 0 to 3 at time of study entry.

          5. Left Ventricular Ejection Fraction (LVEF) ≥ 45% measured by bidimensional echography
             or radionuclide ventriculography (MUGA scan).

        Main Exclusion Criteria:

          1. Participants must not have been treated with any prior chemotherapy for EATL. Patients
             with previous treatment for refractory celiac disease (i.e., immunosuppressive or
             immunoregulatory drugs) may be included.

          2. Known central nervous system involvement by EATL.

          3. Active chronic hepatitis B or C.

          4. HIV positive serology.

          5. HTLV-1 positive serology.
      
Maximum Eligible Age:69 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate the 2-year progression-free survival
Time Frame:4 years
Safety Issue:
Description:2-year progression-free survival (PFS)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Imagine Institute

Last Updated