Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL
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ClinicalTrials.gov Identifier: NCT02462538 |
Recruitment Status :
Terminated
(Due to slow recruitment, recruitment of new patients was stopped, FU was completed for enrolled patients)
First Posted : June 4, 2015
Last Update Posted : March 3, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | May 18, 2015 | |||
First Posted Date ICMJE | June 4, 2015 | |||
Last Update Posted Date | March 3, 2022 | |||
Actual Study Start Date ICMJE | November 3, 2015 | |||
Actual Primary Completion Date | November 3, 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL | |||
Official Title ICMJE | 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 | |||
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 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | ALK+ Anaplastic Large Cell Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Brentuximab vedotin and Imatinib
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
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
3 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Actual Study Completion Date ICMJE | November 3, 2021 | |||
Actual Primary Completion Date | November 3, 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02462538 | |||
Other Study ID Numbers ICMJE | AGMT_ALCL1 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Arbeitsgemeinschaft medikamentoese Tumortherapie | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Arbeitsgemeinschaft medikamentoese Tumortherapie | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Arbeitsgemeinschaft medikamentoese Tumortherapie | |||
Verification Date | February 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |