Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL
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|ClinicalTrials.gov Identifier: NCT02462538|
Recruitment Status : Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|ALK+ Anaplastic Large Cell Lymphoma||Drug: Brentuximab vedotin Drug: Imatinib||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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
Drug: Brentuximab vedotin
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.
Other Name: Adcetris
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.
Other Name: Glivec
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462538
|Universitätsklinik für Innere Medizin V|
|Innsbruck, Austria, A-6020|
|AKH Linz, Innere Medizin 3, Zentrum f. Haematologie u. med. Onkologie|
|Linz, Austria, A-4021|
|Universitätsklinik der PMU, Universitätsklinik für Innere Medizin III|
|Salzburg, Austria, 5020|
|Universitätsklinik f. Innere Medizin I, AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie|
|Wien, Austria, 1090|