Status:
COMPLETED
Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) or Prolymphocytic Leukemia (PLL)
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Amgen
Conditions:
B-cell Chronic Lymphocytic Leukemia
Hematopoietic/Lymphoid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and the best dose of carf...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of carfilzomib in patients with relapsed or refractory Chronic Lymphocytic Leukemia(CLL) / Small ...
Eligibility Criteria
Inclusion
- Previously treated patients with a diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic leukemia (PLL) by NCI Criteria with intermediate or high risk B-Cell chronic lymphocytic leukemia (CLL)(Modified Rai stage) satisfying at least one of the criteria for active disease requiring treatment;patients with a history of Richter's transformation are eligible if they now have evidence of chronic lymphocytic leukemia (CLL) only, with \< 10% large cells in the bone marrow
- Massive or progressive splenomegaly and/or lymphadenopathy; or need for cytoreduction for stem cell transplant
- Anemia (hemoglobin \< 11 g/dl) or thrombocytopenia (platelets \< 100 x 10\^9/L)
- Presence of weight loss \> 10% over the preceding 6 month period
- NCI grade 2 or 3 fatigue
- Fevers \> 100.5 °C or night sweats for greater than 2 weeks without evidence of infection
- Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of less than 6 months
- Creatinine Clearance (CrCl) \> 15mL/min
- Alanine aminotransferase (ALT) \< 3X upper limit of normal (ULN)
- Bilirubin =\< 2 times the upper limit of normal, unless disease related
- Platelets \>= 20 x 10\^9/L and absence of active bleeding
- Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status =\< 2
- Patients must not have secondary cancers that result in a life expectancy of \<2 years or that would confound assessment of toxicity in this study
- Patients of all racial/ethnic groups are eligible for the study if they meet eligibility criteria outlined-
- Patients must provide written informed consent
Exclusion
- Absence of previously treated chronic lymphocytic leukemia (CLL)
- Female subject that is pregnant or breastfeeding; women of childbearing potential and men must agree to use adequate contraception prior to study entry, duration of study participation,and 30 days following study completion; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;confirmation that the subject is not pregnant must be established by a negative serum -human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
- Patients with congestive heart failure (CHF)in whom pre-treatment hydration would be prohibitive;New York Heart Association (NYHA) Class III/IV CHF is excluded
- Patients who have had treatment for chronic lymphocytic leukemia (CLL) within 2 weeks, although palliative steroids are acceptable
- Patient unable to give written informed consent
- Failure to recover from toxicity of previous radiotherapy or chemotherapy to grade 1
- Patients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics or antivirals are acceptable
- Patients who have previously taken bortezomib
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01212380
Start Date
October 1 2010
End Date
September 1 2015
Last Update
May 9 2016
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210