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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Amgen; Onyx Pharmaceuticals

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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