Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse (HOVON 136 NHL)
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|ClinicalTrials.gov Identifier: NCT03356054|
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : December 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|DLBCL||Combination Product: R-DHAP Drug: Brentuximab Vedotin||Phase 1 Phase 2|
Patients with primary refractory or relapse diffuse large B cell lymphoma (DLBCL) after R-CHOP have a dismal prognosis. Only 25% long term survivors are observed after salvage with high-dose chemotherapy followed by autologous stem cell transplantation (ASCT). CD30 expression is observed in 30% of refractory/relapse DLBCL.
Monotherapy with brentuximab vedotin is effective in relapse CD30 positive DLBCL. The addition of brentuximab vedotin to R-DHAP might improve the prognosis of these patients.
Treatment will consist of 3 cycles of brentuximab-vedotin in combination with R-DHAP. During the phase I part the recommended dose level for this combination will be established. Cycles will be given every 3 weeks.
Responsive patients will be treated with BEAM followed by ASCT. Total treatment duration is approximately 16 weeks.
Subsequently patients will be followed until 5 years after registration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (R-DHAP) in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Stem Cell Transplantation|
|Actual Study Start Date :||March 5, 2018|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||February 2027|
Experimental: Brentuximab vedotin-R-DHAP
Brentuximab vedotin added to R-DHAP
Combination Product: R-DHAP
3 cycles q 3 weeks
Drug: Brentuximab Vedotin
3 cycles q 3 weeks added to R-DHAP
Other Name: Adcetris
- The rate of patients with serious toxicity during cycle 1-2 of the combination brentuximab vedotin-R-DHAP [ Time Frame: 6 weeks ]Phase I
- Metabolic CR rate (PET-diagnostic CT) after the third cycle of brentuximab vedotin-R-DHAP salvage therapy [ Time Frame: 9 weeks ]Phase II
- Rate of CTCAE grade 3/4 non-hematological toxicity, including neurotoxicity after each cycle of brentuximab vedotin-R-DHAP [ Time Frame: up to 12 weeks ]Phase II
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): NCT03356054
|Contact: P.J. Lugtenburg, Dr.||+31 (0)10 firstname.lastname@example.org|
|Contact: M. Minnema, Prof. email@example.com|
|Principal Investigator:||P.J. Lugtenburg, Dr.||NL-Rotterdam-ErasmusMC|