Status:
TERMINATED
A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are scheduled to initiate treatment per the recommendations of their primary oncologist, will receive a single d...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female, 18 years old or older.
- A diagnosis of Chronic Lymphocytic Leukemia(CLL) which is CD5/CD19/CD23 positive, confirmed by peripheral blood immunophenotyping and/or lymph node biopsy and immunophenotyping and/or bone marrow biopsy and immunophenotyping. CD23-negative CLL cases are eligible, however additional diagnostic confirmation should include absence of Cyclin D1 rearrangement \[t(11;14)\] as determined by standard laboratory methods (such as fluorescent in situ hybridization).
- Patients are planning to start chemotherapy for CLL recommended and prescribed by their primary oncologist.
- Peripheral blood lymphocyte count above 20,000/mm3
- Be able to provide written informed consent
- Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vincristine.
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Liver function test abnormalities of ≥ grade 3 (total bilirubin \>3 ULN (upper limit of normal), AST\> 5 ULN, ALT\> 5 ULN) as per CTCAE 4.0 criteria, or direct bilirubin ≥ 3.0 mg/dL
- Pre-existing neuropathy grade 2 or greater as per CTCAE 4.0 criteria (moderate symptoms limiting instrumental activities of daily living - ADLs)
- Patients who are pregnant or planning to become pregnant during their participation in the study.
Exclusion
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01463852
Start Date
October 1 2012
End Date
December 1 2014
Last Update
May 12 2015
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756