Status:
TERMINATED
Obatoclax, Fludarabine, and Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluda...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose of obatoclax mesylate in combination with fludarabine phosphate-rituximab (FR) in patients with relapsed chronic lymphocytic leukemia. S...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) or prolymphocytic leukemia (PLL) arising from CLL
- No de novo PLL
- Malignant B cells must co-express CD5 with CD19 or CD20
- Patients who lack CD23 expression on their leukemia cells may not have t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma
- Must have documented lymphocytosis of \> 5,000/uL
- Must require therapy based on any of the following criteria:
- Massive or progressive splenomegaly and/or lymphadenopathy
- Anemia (hemoglobin \< 11 g/dL) or thrombocytopenia (platelet count \< 100,000/uL)
- Presence of weight loss \> 10% over the preceding 6-month period
- NCI grade 2 or 3 fatigue
- Fevers \> 100.5 F or night sweats for \> 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
- Must have received at least one prior therapy for B-CLL
- No known brain metastases
- ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
- Total bilirubin normal (unless due to Gilbert syndrome or compensated hemolysis)
- Life expectancy \> 3 months
- Creatinine normal
- Fertile patients must use effective contraception
- Not pregnant or nursing
- Negative pregnancy test
- Any number of prior therapies allowed
- At least 1 year since prior fludarabine phosphate-rituximab combination therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No chemotherapy or radiotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
- No other concurrent investigational agents
- AST and ALT \< 2.5 times upper limit of normal
- Recovered from all prior therapy
Exclusion
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to obatoclax mesylate or other agents used in study
- Active Coombs' positive autoimmune hemolytic anemia
- Chronic active hepatitis B patients if not on appropriate antiviral therapy (e.g., lamivudine, adefovir)
- Other neurological disorders or dysfunction or a history of seizure disorder
- Uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia including QTc \> 450 msec
- Psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00612612
Start Date
January 1 2008
Last Update
September 30 2013
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115