Study:
A Phase I Trial of Bendamustine Plus Alemtuzumab for the Treatment of Fludarabine Refractory Chronic Lymphocytic Leukemia
Rationale:
n/a
Purpose:
This phase I trial is studying the side effects and best dose of alemtuzumab when given
together with bendamustine hydrochloride in treating patients with relapsed chronic
lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that did not respond to
fludarabine phosphate. Drugs used in chemotherapy, such as bendamustine hydrochloride, work
in different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can also block
cancer growth in different ways. Some block the ability of cancer cells to grow and spread.
Others find cancer cells and help kill them or carry cancer-killing substances to them.
Giving bendamustine hydrochloride together with alemtuzumab may kill more cancer cells.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage III Small Lymphocytic Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Small Lymphocytic Lymphoma |
Drug: Bendamustine Hydrochloride
Biological: Alemtuzumab |
Phase 1 |
Verified by
Case Comprehensive Cancer Center
January, 2013
Sponsored by: Case Comprehensive Cancer Center
Information provided by: Case Comprehensive Cancer Center
ClinicalTrials.gov identifier: NCT00947388
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44195
United States
Matt Kalaycio, MD., Principal Investigator
Paolo Caimi, MD., Principal Investigator