NCT03132584

Cyclophosphamide and Alemtuzumab In Lymphoma

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Non Hodgkin Lymphoma
• High-grade B-cell Lymphoma
• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	The chemotherapy drugs will be given in the hospital. During the first cycle of treatment, participants will stay in the hospital until their blood counts have recovered after treatment. During cycles 2 and 3, participants may go home after chemotherapy if they are doing well. The length of each cycle is 28 days \- Via IV Day 3
DRUG	Alemtuzumab	* The chemotherapy drugs will be given in the hospital. During the first cycle of treatment, participants will stay in the hospital until their blood counts have recovered after treatment. During cycles 2 and 3, participants may go home after chemotherapy if they are doing well. The length of each cycle is 28 days * Alemtuzumab will be administered as follows: * IV Day 1 * IV Day 2 * Target dose IV on Day 3 and 4

Timeline

• Start date: 2017-07-30
• Primary completion: 2018-01-30
• Completion: 2018-01-30
• First posted: 2017-04-28
• Last updated: 2019-01-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study