Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05991388 | A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma | PHASE2 | RECRUITING | 210 | — | — | May 2, 2024 | May 1, 2033 | Feb 20, 2026 | 11 | Australia, Austria +5 |
Occurrence of an objective response (OR) i.e. Complete Response (CR) or Partial Response (PR) after 12 weeks of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)
Occurrence of CR within a maximum of three cycles of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)
| Arm | Type | Description |
|---|---|---|
| Treatment Arm I - BsAb - Odronextamab | EXPERIMENTAL | Patients will receive odronextamab given as an intravenous infusion weekly for 12 weeks, then every two weeks until nine months, and every four weeks thereafter until progression or for a maximum of two years |
| Treatment Arm II - ADC with Standard Chemotherapy - Loncastuximab tesirine with modified R-ICE | EXPERIMENTAL | Patients will receive loncastuximab tesirine given as a 30-minute intravenous infusion with each cycle of modified R-ICE (maximum three cycles) |
| Treatment Arm III - CAR T-cells - TBC | EXPERIMENTAL | Patients will receive CAR-T cell therapy - agent TBC |
| Name | Type | Description |
|---|---|---|
| Odronextamab | DRUG | CD20xCD3 bispecific antibody |
| Loncastuximab tesirine | DRUG | CD-19-directed antibody-drug conjugate |
| Rituximab | DRUG | Modified R-ICE chemotherapy |
| Ifosfamide | DRUG | Modified R-ICE chemotherapy |
| Carboplatin | DRUG | Modified R-ICE chemotherapy |
| Etoposide | DRUG | Modified R-ICE chemotherapy |
| Etoposide Phosphate | DRUG | Modified R-ICE (Treatment Arm II) |
| Dexamethasone | DRUG | Modified R-ICE chemotherapy |
| CAR T-cells (TBC) | BIOLOGICAL | Modified R-ICE chemotherapy |
Inclusion criteria applicable to all treatment arms: * Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma/Leukaemia or atypical Burkitt/Burkitt-like lymphoma, primary mediastinal large B-cell lymphoma (PMLBL), and mature B-NHL/Not Otherwise Specified (NOS)) ...