CLINICAL TRIALS PROFILE FOR LEMTRADA

All Clinical Trials for LEMTRADA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00230282 ↗	Phase 2 Fludarabine, Cytoxan and FCCAM in Untreated B-Cell Chronic Lymphocytic Leukemia	Completed	Bayer	Phase 2	2004-07-01	The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
NCT00230282 ↗	Phase 2 Fludarabine, Cytoxan and FCCAM in Untreated B-Cell Chronic Lymphocytic Leukemia	Completed	Steven E. Coutre	Phase 2	2004-07-01	The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
NCT00565773 ↗	Belatacept Post Depletional Repopulation to Facilitate Tolerance	Completed	Bristol-Myers Squibb	Phase 2	2007-12-01	Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection typically most often develops in the first few months after a transplant. This single center study will seek to determine if a new combination of anti-rejection medications, including the recently FDA approved drug called Belatacept, is better than the current standard anti-rejection drug regimen at preventing rejection. Also to be determined will be whether the new combination of drugs will allow participants to wean off their oral anti-rejection medications over time. This study will test the safety and effectiveness of a new investigational drug combination using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow. This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is approved for use in some types of white blood cell cancers, but is considered investigational in transplant patients. Belatacept is now FDA approved and is being studied in transplant patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational. In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone marrow from the kidney donor would improve the effect of these drugs. This bone marrow infusion was also considered investigational. Enrollment of 20 additional subjects began in January, 2013. The donor bone marrow infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney recipients. Enrollment was closed as of 8/12/2014.

Clinical Trial Conditions for LEMTRADA

Condition Name

Condition Name for LEMTRADA
Intervention	Trials
Multiple Sclerosis	4
Sickle Cell Disease	3
Leukemia	2

Condition MeSH

Condition MeSH for LEMTRADA
Intervention	Trials
Multiple Sclerosis	8
Sclerosis	7
Multiple Sclerosis, Relapsing-Remitting	4

Clinical Trial Locations for LEMTRADA

Trials by Country

Trials by Country for LEMTRADA
Location	Trials
United States	89
Netherlands	4
Canada	4
Poland	4
Belgium	3

Trials by US State

Trials by US State for LEMTRADA
Location	Trials
New York	6
Illinois	6
California	5
Colorado	4
Texas	4

Clinical Trial Progress for LEMTRADA

Clinical Trial Phase

Clinical Trial Phase for LEMTRADA
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for LEMTRADA
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	4
Recruiting	3

Clinical Trial Sponsors for LEMTRADA

Sponsor Name

Sponsor Name for LEMTRADA
Sponsor	Trials
Genzyme, a Sanofi Company	6
National Cancer Institute (NCI)	3
Emory University	2

Sponsor Type

Sponsor Type for LEMTRADA
Sponsor	Trials
Other	21
Industry	8
NIH	4