Hodgkin Lymphoma Clinical Trial
Official title:
A Proof-of-Concept Multicenter Trial Evaluating Response Adapted Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
The goal of this clinical trial is to study the combination of nivolumab and axatilimab in patients with relapsed/refractory classical Hodgkin Lymphoma. This study will mainly look at if the combination works as expected.
This study is a phase II, proof-of concept, prospective, multi-center study of combination of nivolumab and Axatilimab (SNDX-6352) in subjects with relapsed/refractory classical Hodgkin lymphoma. Nine evaluable patients will be enrolled and receive Axatilimab 3mg/kg Q4 weeks in combination with nivolumab 480mg Q4 weeks. If more than one DLT is observed during the DLT period (first two cycles) in the first 6 patients, the study drug dose will be reduced to 2mg/kg and additional patients (up to 6 at 2mg/kg dose) may be included to the study. This could result in maximum 12 patients for the entire study. The combination of Nivolumab and Axatilimab will be continued until progression/toxicity or a maximum of 12 months of treatment. The investigators expect that in patients who respond to this combination, the tumor microenvironment will shift towards immunocompetent phenotype within a few months of combination treatment. Thus, there may not be further benefit of continuing the combination for more than 12 months. If patients have responded to the combination, patients are able to continue anti-PD(L)1 off-study after 12 months as their tumor microenvironment might have reset for it to work better. Safety Run-In A total of 6 to 9 subjects may be evaluated in Part 1 depending on the frequency of DLTs and the need for dose reductions. A dose de-escalation design will be used to determine the recommended phase 2 dose, while ensuring the safety and tolerability of the treatment. In this trial, the dose determined to be the maximum tolerated dose will be the recommended phase 2 dose for a potential future study. The study may test two dose levels of Axatilimab (SNDX-6352) as described in the protocol. ;
| 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 |