Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large-Cell, Anaplastic

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma, T-Cell

Lymphosarcoma

Anaplastic Large Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Brentuximab Vedotin

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Tyrosine

Brentuximab vedotin (every 3 weeks i.v., 1.8 mg/kg) and imatinib (200mg daily orally, escalated from 100mg daily) for up to 48 weeks

Brentuximab vedotin is given in a 21 day cycle intravenously starting at 1.8 mg/kg on day 1 of the first cycle and will be administered by IV infusion given over approximately 30 minutes on day 1 of each 21-day cycle.

Brentuximab vedotin

Imatinib will be given orally at a dose of 100mg daily starting from day 1 of the first cycle. The dose will be increased to 200mg daily starting from day 1 of the second cycle if no DLT occurs during the first cycle and will be continued at 200mg for 48 weeks.

Imatinib

Ulrich Jäger, MD

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.

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.

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

A "Window of Opportunity" Trial With Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ Anaplastic Large Cell Lymphoma or Patients Ineligible for Chemotherapy

Arbeitsgemeinschaft medikamentoese Tumortherapie

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL	NCT02462538	ALK+ Anaplastic...	Brentuximab ved... Imatinib	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL	NCT02462538	ALK+ Anaplastic...	Brentuximab ved... Imatinib	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie

Spots Global Cancer Trial Database for alk+ anaplastic large cell lymphoma