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A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
Trial ID: NCT00649584
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.
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
- 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
- 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.
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