Clinical trial · Interventional
A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
A Phase 1 Study to Estimate MMAE Metabolites in Human Plasma and Urine in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma or Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma Receiving Brentuximab Vedotin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large-cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
| Brentuximab vedotin and rifampicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Brentuximab vedotin
- description
- Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
- interventionNames
- Drug: brentuximab vedotin
- type
- EXPERIMENTAL
- label
- Arm B: Brentuximab vedotin and rifampicin
- description
- Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.
- interventionNames
- Drug: Brentuximab vedotin and rifampicin
Primary outcomes (41)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female participants between 18 years and 75 years old, with relapsed or refractory HL or relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy * Measurable disease * An Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 * Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence * Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence * Clinical laboratory values as specified in the study protocol Exclusion Criteria: * Participants for whom rifampicin is contraindicated * Previously received an allogeneic transplant. * Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants whose ALCL has transformed to sALCL are eligible). * Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML) * Female participants who are lactating and breastfeeding or pregnant * Known human immunodeficiency virus (HIV) positive, * Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
References
Publications (0)
Data not yet available