Cyclophosphamide and Alemtuzumab In Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03132584|
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : October 31, 2018
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:
|Condition or disease||Intervention/treatment||Phase|
|Non Hodgkin Lymphoma High-grade B-cell Lymphoma CD52 Positive Non-Hodgkin Lymphoma DLBCL or High-grade B-cell Lymphoma NOS||Drug: Cyclophosphamide Drug: Alemtuzumab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase I study in the standard 3+3 dose escalation design|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Cyclophosphamide and Alemtuzumab in CD52 Positive Relapsed/Refractory Double-Hit Lymphoma, Diffuse Large B-cell Lymphoma or High Grade B-cell Lymphoma, NOS With MYC and BCL-2 Over-expression, MYC-Positive Transformed Follicular Lymphoma, and CD52 Positive Mature T-cell Lymphoproliferative Disorder|
|Actual Study Start Date :||July 30, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||May 1, 2023|
Experimental: Cyclophosphamide and Alemtuzumab
After the screening procedures confirm participation in the research study:
The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have CD52 positive aggressive lymphoma. Not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated.
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
Other Name: Campath
- MTD of Cyclophosphamide and Alemtuzumab [ Time Frame: 28 days ]
- Overall Response Rate [ Time Frame: 12 Months ]Non-Hodgkin Lymphoma Response Criteria, which will be reported descriptively
- Complete Response Rate [ Time Frame: 12 Months ]Non-Hodgkin Lymphoma Response Criteria, which will be reported descriptively
- Progression Free Survival [ Time Frame: up to 5 years ]Progression-free will be estimated using the method of Kaplan and Meier.
- Overall Survival [ Time Frame: up to 5 years ]Overall survival will be estimated using the method of Kaplan and Meier.
- Response Rate [ Time Frame: 28 Days ]Assess response by PET/CT and in the bone marrow after one cycle of therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132584
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Ann LaCasce, MD||Dana-Farber Cancer Institute|