Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
Ph1 Cyclophosphamide & Alemtuzumab in CD52+ R/R Double-Hit, Diffuse Lg B-cell or High Gr B-cell Lymphomas, NOS With MYC & BCL2 Over-expression, MYC-Positive Transformed Follicular Lymphoma, & CD52+ Mature T-cell Lymphoproliferative Disorder
This research study is studying a combination of chemotherapy drugs as a possible treatment
for aggressive lymphoma that has not responded to standard treatment.
The names of the study interventions involved in this study are:
- Cyclophosphamide
- Alemtuzumab
This research study is a Phase I clinical trial, which tests the safety of an investigational
intervention and also tries to define the appropriate dose of the investigational
intervention to use for further studies. "Investigational" means that the intervention is
being studied.
The FDA (the U.S. Food and Drug Administration) has not approved alemtuzumab for aggressive
lymphoma but it has been approved for other uses.
In this research study, the investigators are studying the combination of cyclophosphamide
and alemtuzumab in participants with several types of aggressive lymphoma which are positive
for a protein called CD52, the target of alemtuzumab. Studies in laboratory models of CD52
positive lymphoma showed the combination of cyclophosphamide and alemtuzumab was very
effective. Cyclophosphamide causes a specific type of immune cell, called a macrophage, to
attack lymphoma cells treated with alemtuzumab. Both drugs have been used in participants
with lymphoma but have not been previously combined in this way. The investigators hope to
identify the highest dose of the drugs that can be safely given together and to see if the
combination if effective in treating these lymphomas.
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