Clinical trial · Interventional
Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma
Pilot Study of Rituximab and Brentuximab Vedotin With Deferred BMT for Relapsed Classical Hodgkin Lymphoma
NCT01900496CI-TRIAL-00035325terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab vedotin | Biological | Brentuximab Vedotin | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brentuximab vedotin & Rituximab
- description
- Brentuximab vedotin: Will be administered at 1.8 mg/kg IV over 30 minutes is given for up to 10 doses (cycles), with a cycle length of 21 days. Brentuximab vedotin is first given on day 1 of cycles 1, 2, 3, and 4 as a single agent (weeks 0, 3, 6, and 9, respectively). Four cycles are chosen because of the 12-week median time to CR in the pivotal phase 2 trial of brentuximab vedotin after autologous BMT for HL. Brentuximab vedotin will be administered with Rituximab at 375 mg/m2 IV is given for up to 8 "induction" doses: day 1 of week 6, 7, 8, and 9; day 1 of week 12, 15, 18 and 21. This is followed by rituximab "maintenance" (375 mg/m2 IV once every 3 months x 2 doses) to complete a \~ 1 year total course of therapy.
- interventionNames
- Biological: Brentuximab vedotin
- Biological: Rituximab
Primary outcomes (1)
- measure
- Failure-free survival
- timeFrame
- Up to 7 months
- description
- Percentage of participants alive without any of the following: death, disease progression or relapse, or failure to achieve complete remission as defined by the Cheson criteria. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 16 years * Biopsy-proven diagnosis of classical Hodgkin Lymphoma (regardless of HRS cell CD20 expression) per the World Health Organization classification criteria24; lymphocyte predominant histology is excluded * Untreated relapse of classical Hodgkin Lymphoma (with the exception of steroids) as follows:HL that relapsed \> 3 months after completion of first-line chemotherapy or combined modality therapy, and has not yet been treated with salvage chemotherapy, Stage I-II HL that relapsed \> 3 months after first-line chemotherapy, then relapsed after radiation therapy delivered with curative intent, and has not yet been treated with salvage chemotherapy * Radiographically measurable disease (\> 1 focus of lymphoma measuring \> 1.5 cm) * Baseline laboratories: ANC \> 1000/uL and platelets \> 75,000/uL, unless due to bone marrow involvement by lymphoma, Serum creatinine \< 2.0 mg/dL, Total bilirubin \< 2.0 mg/dL (excluding Gilbert's syndrome), unless due to lymphoma * ECOG performance status 0, 1 or 2. Exclusion Criteria: * Active concurrent malignancy with the exception of superficial non-melanoma skin cancer and cervical carcinoma in situ. * Primary induction failure, defined as failure to achieve CR with first-line chemotherapy or chemoradiation, disease progression during first-line chemotherapy or chemoradiation, or progression or biopsy-proven disease persistence within 8 weeks of first-line therapy completion * Prior brentuximab vedotin or rituximab for lymphoma * Grade \> 2 peripheral neuropathy * HIV infection, active hepatitis B infection, or active hepatitis C infection
References
Publications (0)
Data not yet available
No reference posted for this study.