Hodgkin Lymphoma Clinical Trial
Official title:
A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123 has been approved for treatment in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This trial aims to examine the safety of this novel agent in pediatric patients with relapsed/refractory hematologic malignancies. The mechanism by which tagraxofusp kills cells is distinct from that of conventional chemotherapy. Tagraxofusp directly targets CD123 that is present on tumor cells, but is expressed at lower or levels or absent on normal hematopoietic stem cells. Tagraxofusp also utilizes a payload that is not cell cycle dependent, making it effective against both highly proliferative tumor cells and also quiescent tumor cells. The rationale for clinical development of tagraxofusp for pediatric patients with hematologic malignancies is based on the ubiquitous and high expression of CD123 on many of these diseases, as well as the highly potent preclinical activity and robust clinical responsiveness in adults observed to date. This trial includes two parts: a monotherapy phase and a combination chemotherapy phase. This design will provide further monotherapy safety data and confirm the FDA approved pediatric dose, as well as provide safety data when combined with chemotherapy. The goal of this study is to improve survival rates in children and young adults with relapsed hematological malignancies, determine the recommended phase 2 dose (RP2D) of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients. About 54 children and young adults will participate in this study. Patients with Down syndrome will be included in part 1 of the study.
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 |