Obatoclax, Fludarabine, and Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia

Stopped early · Phase 1

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Leukemia, Prolymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

In brief

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 fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving obatoclax together with fludarabine and rituximab may kill more cancer cells. This phase I trial is studying the side effects and best dose of obatoclax when given together with fludarabine and rituximab in treating patients with B-cell chronic lymphocytic leukemia.

Key facts

Study ID: NCT00612612
Run by: National Cancer Institute (NCI)
People needed: 28
Starts: 2008-01-01
Last updated by the study team: 2013-09-30

Who can join

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

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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