BV After Allogeneic Hematopoietic Stem Cell Transplantation (BV-ALLO)
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|ClinicalTrials.gov Identifier: NCT03540849|
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Despite a high recovery rate with chemotherapy and radiation therapy treatment, 15 to 30% of patients suffering from Hodgkin lymphoma are refractory or relapsed. Standard rescue treatment for these patients is chemotherapy followed by a hematopoietic stem cell auto-SCT. Despite a very good rate of complete sustainable response in 50% of the patients, another 50% of the patients relapse after increased therapy and require additional treatment. Consequently, one option for these patients is to offer a novel rescue therapy, enabling them to have partial or complete response, and offer them a hematopoietic stem cell allo-SCT. In the only prospective phase 2 study published by Sureda et al. assessing this therapeutic approach, the rate of mortality not linked to relapse was 8% at 100 days and 15% at 1 year. The progression-free survival rate was 48% at 1 year and 24% at 4 years. Relapse occurred between 3 and 35 months with a median of 6 months in 51% of the patients out of a total of 78 patients. Cumulative incidence of relapse was 37% at 1 year and 59% at 5 years.
Brentuximab Vedotin (Bv) is an anti-CD30 antibody-drug conjugate. This drug has shown its efficacy with very acceptable toxicity in patients suffering from advanced-stage Hodgkin lymphoma. Bv was consolidatively evaluated after an auto-SCT. 329 patients, at high risk of relapse after auto-SCT, received Bv (n=165) in a dose of 1.8 mg/kg every 3 weeks or a placebo (n=164) for 16 cycles. The progression-free survival median (validated by a panel of independent experts) was 42.9 months (95% CI 30,4-42 ; 9) for patients in the Bv group and 24.1 months (11.5 not reached) in the placebo group.
The purpose of our study is to reduce relapse rate by carrying out maintenance with Bv after allografting hematopoietic stem cells in a population of patients suffering from Hodgkin lymphoma with high risk of relapse after auto-SCT. Fifty eight patients have been slated for inclusion over a period of 2 years.
This is an open-label, prospective, multicenter, phase II trial consisting of post allo-SCT maintenance Bv for Hodgkin lymphoma.
Patients will be recruited over 24 months and be followed for 3 years after allo-SCT.
A total of 58 patients will be included in the study. The duration of the treatment period is approximately 10.7 months for 12 cycles of Bv.
End of study: end of study is defined by the last visit planned by the protocol of the last patient in follow-up, which means 3 years after allo-SCT.
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Brentuximab Vedotin (Bv)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study.|
|Actual Study Start Date :||March 7, 2018|
|Estimated Primary Completion Date :||March 7, 2020|
|Estimated Study Completion Date :||March 7, 2023|
|Experimental: BV after allogeneic hematopoietic stem cell transplantation||
Drug: Brentuximab Vedotin (Bv)
HL patients who are eligible for the study, will receive maintenance Bv. The first Bv dosage will be administered three months after allo-SCT (day 90) at the dosage of 1.8 mg/kg every 21 days for 12 cycles. post allo-SCT maintenance Bv for Hodgkin lymphoma
- Cumulative incidence of relapse (CIR) or progression at 12 months after allo-SCT [ Time Frame: 12 month after allo-SCT ]
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): NCT03540849
|Contact: Anne Claire GAC, MD||02.31.27.25.39 ext +firstname.lastname@example.org|
|Caen University Hospital||Recruiting|
|Contact: GAC Anne Claire, MD|
|Principal Investigator: GAC Anne Claire, MD|