Clinical trial · Interventional
A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies
NCT00649584CI-TRIAL-00016387terminatedPhase 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): Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.
Summary
Brief summary (as posted)
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease, Hodgkin | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma, Large-Cell, Anaplastic | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| SGN-35 | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- SGN-35 alone or in combination with gemcitabine
- interventionNames
- Drug: SGN-35
- Drug: gemcitabine
Primary outcomes (1)
- measure
- Incidence of adverse events and laboratory abnormalities
- timeFrame
- 1 month after last dose
Secondary outcomes (3)
- measure
- PK profile
- timeFrame
- 2 months after last dose
- measure
- Immunogenicity (anti-SGN-35 antibodies)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed CD30-positive hematologic malignancy. * Patients with HL must have failed systemic chemotherapy. * Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy. * Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique. Exclusion Criteria: * Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible). * History of allogeneic stem cell transplant. * Patients who have had previous treatment with any anti-CD30 antibody.
References
Publications (1)
- RESULTFanale MA, Forero-Torres A, Rosenblatt JD, Advani RH, Franklin AR, Kennedy DA, Han TH, Sievers EL, Bartlett NL. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012 Jan 1;18(1):248-55. doi: 10.1158/1078-0432.CCR-11-1425. Epub 2011 Nov 11. PMID 22080439