Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Indolent Adult Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma

In brief

This phase II trial studies how well giving vorinostat, cladribine, and rituximab together works in treating patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or B cell non-Hodgkin's lymphoma (NHL) that has returned after a period of improvement. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving vorinostat together with cladribine and rituximab may kill more cancer cells.

Key facts

Study ID

NCT00764517

Run by

OHSU Knight Cancer Institute

People needed

57

Starts

2008-08-01

Expected to finish

2017-03-01

Last updated by the study team

2017-12-11

Who can join

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

You may qualify if…

• Patients must be able to provide informed consent according to institutional guidelines
• Patients must have: 1) MCL; or 2) relapsed or refractory cluster of differentiation (CD)20 positive B-cell indolent NHL; or 3) relapsed CLL
• Patients must have measurable disease/disease status requirements as follows:
• For CLL patients, symptomatic disease as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria that mandate treatment
• For B-cell NHL patients must have at least one of the following to be eligible:
• Positron emission tomography (PET) avid or measurable disease by computed tomography (CT) scan defined as at least 1 lesion that measures > 2 cm in a single dimension
• Significant bone marrow and/or peripheral blood involvement by NHL (i.e. leukemic phase) as determined by the investigator
• Patients with Waldenström macroglobulinemia (WM) are exempt from this requirement if they have symptomatic hyperviscosity or clinically relevant cytopenias and elevated serum immunoglobulin M (IgM)
• Patients must have adequate bone marrow reserve as indicated by an absolute neutrophil count (ANC) > 1.500/mm\^3 and platelet count > 150.000/mm\^3 if no bone marrow involvement; however, if there is significant lymphoma/leukemia bone marrow infiltration, no pre-existing hematologic parameters must be met
• Patients must have a performance status of 0, 1, or 2 according to Eastern Cooperative Oncology Group
• Serum creatinine < 2.0 mg/dL or estimated glomerular filtration rate (GFR) > 60 mL/min
• Serum bilirubin =< 1.5 × upper limit of normal (ULN)
• Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 × ULN
• Alkaline phosphatase =< 2.5 × ULN
• Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
• Male and female patients must agree to use an effective contraceptive method during the study and for a minimum of 6 months after study treatment

You may not qualify if…

• Significant hypersensitivity to cladribine or vorinostat; hypersensitivity to rituximab infusion is not an exclusion criterion; however, appropriate changes to infusion schedules will be made based on current or prior reactions
• Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
• Patients with a diagnosis of a relapsed/refractory aggressive cluster of differentiation antigen 20 (CD20)+ B-cell neoplasm defined as Burkitt's lymphoma or diffuse large B-cell lymphoma
• A diagnosis of acute lymphoplasmic leukemia, and lymphoblastic lymphoma
• Use of investigational agents or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea and steroids; the patient must have recovered from all acute toxicities from any previous therapy
• Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment
• Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
• Pregnant or lactating patients
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
• Patients with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) associated complex are not eligible for treatment
• Patients with active hepatitis B or C are not eligible for the study
• Patients taking other histone deacetylases (HDAC) inhibitors; for example, patients taking valproic acid, there must be a 14 day washout period prior to enrollment in this study

Where it is running

• OHSU Knight Cancer Institute — Portland, Oregon, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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