Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II, Multicenter, Open Label Study of Treatment Intensification With ACVD and Brentuximab-Vedotin in Advanced-stage Hodgkin Lymphoma Patients With a Positive Interim PET Scan After 2 ABVD Cycles
This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in order to improve the overall long-term disease control in the entire cohort of advanced-stage HL.
With the aim of reducing Blemoycin pulmonary injury (BPI) , Bleomycin was withdrawn and
substituted with Cyclophosphamide (ACVD cycle) in patients with a PET-2 negative. All
advanced stage HL patients will receive 2 cycles of the standard treatment ABVD and assessed
with PET-2 scan.
Knowing that Cyclophosphamide toxicities include cytopenias, amenorrhea and male infertility.
These toxicities are mainly dependent on the total cumulative dose. Doses less than 4 g/m2
are not associated with sterility or major toxicity, doses higher than this can lead to
azoospermia which was reversible in many cases therefore the cumulative dose will be used in
this study is 3200 mg. Additionally, Brentuximab Vedotin has shown significant activity in
relapsed refractory HL with minor toxicities.
PET scan after 2 cycles of ABVD has proven to be an excellent tool to identify patients that
will have long term PFS of 95% when it is negative and only progression-free survival (PFS)
of less than 15% when it is positive.
The primary endpoint of the study will be to assess the overall 3-Y PFS of the entire cohort
of patients.
;
| 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 |