Ignite Creation Date:
2024-05-06 @ 7:06 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02462538
Status:
TERMINATED
Last Update Posted:
2022-03-03
First Post:
2015-05-18
Brief Title:
Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK ALCL
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Organization:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Overview
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 Ineligible for Chemotherapy
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow recruitment recruitment of new patients was stopped FU was completed for enrolled patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 18 mgkg body weight In the absence of a dose limiting toxicity DLT ie 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
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 18 mgkg body weight In the absence of a dose limiting toxicity DLT ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None