Chronic Lymphocytic Leukemia
This is a Phase I, multicenter, open-label, dose-escalation study of DCDS4501A administered as a single agent by IV infusion to patients with relapsed or refractory hematologic malignancies.
Treatment will be administered on an outpatient basis at SCCA with IV infusion. The first infusion takes 90 minutes with a 90-minute observation. Subsequent infusions will take 30 minutes followed by a 30-minute observation (provided the first infusion is well tolerated). Infusions will be once a day every 21 days, with several additional visits for labs and follow up. A total of eight treatments will be given initially, after which patients may qualify to receive an additional six months of treatment if they respond to treatment. Patients will be treated on this study at SCCA. There are some time limits for how recent past treatments may have occurred, but nothing too restrictive.
- Life expectancy of at least 12 weeks
- History of one of the following histologically-documented hematologic malignancy that is expected to express the CD79b antigen and for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), Grade 3b FL, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
- All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable lesion
- For all men or women of childbearing potential (unless surgically sterile): use of adequate methods of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
- Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse events from any previous treatments must be resolved or stabilized prior to Cycle 1, Day 1, except for neuropathy
- Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
- Prior allogeneic stem cell transplant
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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