Clinical Trial: Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A "Window of Opportunity" Trial With Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ Anaplastic Large Cell Lymphoma or Patients Ine

Brief Summary: This is an open label pilot study of combining BV in a licensed indication with imatinib in patients with ALCL. It is intended as a "window of opportunity" trial in which the study drugs will be given as an initial substitute for conventional chemotherapy with the intention to achieve a remission enabling the patients to proceed to autologous or allogeneic stem cell transplantation, if eligible.

Detailed Summary:

Patients will be included in this trial if they have relapsed or refractory ALK+ ALCL after at least one line of conventional chemotherapy or if they are ineligible for conventional chemotherapy.

Imatinib will be given continuously starting from day 1 of the first cycle at an oral dose of 100mg daily. The dose will be increased to 200mg daily starting from day 1 of the second cycle if no DLT occurs during the first cycle. BV will be given 3 weekly starting on day 1 at a dose of 1.8 mg/kg body weight. In the absence of a dose limiting toxicity (DLT) i.e. haematological toxicity ≥ grade 2, non- haematological toxicity ≥ grade 3, after 3 weeks of therapy, and in the presence of a clinical response (CR or PR) after cycle 1, the BV dose will continue every 3 weeks for 48 weeks. Dose modifications and stopping rules will be introduced as described in chapter 6. In case of progression at any time during the study the patient will go off trial and receive salvage treatment.


Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Current Primary Outcome: Safety of brentuximab vedotin and imatinib regime as measured by type, frequency and severity of adverse events (AEs) and their relationship to study treatment [ Time Frame: up to 6 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Efficacy of brentuximab vedotin and imatinib regime as measured by proportion of patients responding to treatment [ Time Frame: up to 6 years ]
  • Ability to receive further Treatment as measured by number of patients being able to receive transplantation [ Time Frame: up to 6 years ]
  • Progression-free survival as measured by proportion of patients displaying progressive disease [ Time Frame: up to 6 years ]
  • Overall survival as measured by documentation of deaths [ Time Frame: up to 6 years ]


Original Secondary Outcome: Same as current

Information By: Arbeitsgemeinschaft medikamentoese Tumortherapie

Dates:
Date Received: May 18, 2015
Date Started: May 2015
Date Completion: June 2021
Last Updated: May 25, 2016
Last Verified: May 2016