Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) or Prolymphocytic Leukemia (PLL)

Completed · Phase 1

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Hematopoietic/Lymphoid Cancer, Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia

In brief

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 carfilzomib in treating patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic lymphoma(SLL), or prolymphocytic leukemia (PLL).

Key facts

Study ID: NCT01212380
Run by: Ohio State University Comprehensive Cancer Center
People needed: 21
Starts: 2010-10-01
Expected to finish: 2015-09-01
Last updated by the study team: 2016-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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