Hodgkin Lymphoma Clinical Trial
Official title:
Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
| Active, not recruiting |
NCT03617666 -
Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study
|
Phase 2 | |
| Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
| Recruiting |
NCT02507479 -
Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
|
Phase 2 | |
| Active, not recruiting |
NCT02191930 -
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
|
Phase 2 | |
| Completed |
NCT01943682 -
Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma
|
Phase 1 | |
| Completed |
NCT01393106 -
Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma
|
Phase 2 | |
| Terminated |
NCT00992030 -
R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma
|
Phase 3 | |
| Terminated |
NCT00722865 -
Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma
|
Phase 2 | |
| Unknown status |
NCT00598624 -
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
|
Phase 2 | |
| Completed |
NCT03242902 -
To Decrease Fatigue With Light Therapy
|
Phase 3 | |
| Active, not recruiting |
NCT05205512 -
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
|
N/A | |
| Recruiting |
NCT03681561 -
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03250962 -
SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04510610 -
Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
|
Phase 2/Phase 3 | |
| Completed |
NCT06295211 -
Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
|
||
| Active, not recruiting |
NCT02256137 -
A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
|
||
| Completed |
NCT02432235 -
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma
|
Phase 1 |