Clinical trial · Interventional
Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)
Safety and Efficacy of Brentuximab Vedotin Maintenance After Allogeneic and Haploidentical Stem Cell Transplantation in High Risk CD30+ Lymphoma (Hodgkin Lymphoma and ALCL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab vedotin can help to prevent the disease from coming back.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brentuximab Vedotin
- description
- Brentuximab by vein over 30 minutes every 3 weeks for a total of 6 cycles starting between days 30 and 60 post allogeneic stem cell transplant (SCT). Brentuximab dose based on actual body weight starting with an initial dose of 1.2 mg/kg for the first 2 cycles and dose increased to 1.8 mg/kg after the second cycle for all subsequent cycles.
- interventionNames
- Drug: Brentuximab Vedotin
Primary outcomes (1)
- measure
- Number of Participants With Secondary Graft Failure
- timeFrame
- An average of 12 months
- description
- Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of \<10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma (ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days (matched related or matched unrelated donors only). 2. Age 18 to 65 years. 3. Performance status: Zubrod 0-1 or Karnofsky 80-100. 4. Serum creatinine \< 1.5 mg/dL or creatinine clearance greater than or equal to 40 cc/min as defined by MDRD method from National Kidney Disease Education Program (NKDEP). 5. Serum direct bilirubin \< 1.5 mg/dL (unless Gilbert's syndrome). 6. SGPT \< 200 IU/L unless related to patient's malignancy. 7. Evidence of neutrophil and platelet engraftment, defined as platelet count equal or greater than 50,000 mm3 independent of platelet transfusion and ANC equal or greater to 1000 without growth factor support for at least 5 days. 8. Patients with previous exposure to brentuximab pre-transplant are eligible for the study. Exclusion Criteria: 1. Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test. 2. Presence of steroid-refractory acute graft-versus-host disease (GVHD). 3. Patients that underwent allogeneic transplantation as a treatment of graft failure. 4. Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV disease.
References
Publications (0)
Data not yet available