At a glance
ClinicalIndex Comparison Record- ✓Age ≥15 years
- ✓Relapsed or refractory chronic lymphoid malignancies with predicted <20% response to conventional/transplant therapy
- ✓B-cell CLL, PLL, hairy cell leukemia, mantle cell, marginal zone, splenic lymphoma with villous lymphocytes, Richter transformation, or LGL/NK-cell leukemia
- ✓Malignant cells express CD52 AND CD20 in ≥20% of cells by flow cytometry or immunohistochemistry (lower expression acceptable if prior monoclonal antibody therapy within 3 months)
- ✕Prior treatment with both rituximab AND Campath-1H (alemtuzumab) in combination
- ✕History of anaphylaxis to rat or mouse-derived CDR-grafted humanized monoclonal antibodies
- ✕Active hepatitis B infection or high HBV risk
- ✕Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks; monoclonal antibodies within 4 weeks prior to start (hormonal replacement permitted)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders
In Brief
A Phase 2 clinical trial evaluating Campath-1H and Rituximab for Chronic Lymphocytic Leukemia. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.
Study Details
Timeline
Interventions
15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.
375 mg/m\^2 IV infusion on day 1, then 500 mg/m\^2 on days 8, 15, and 22.