Status:
COMPLETED
Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine objective response rates of the SCR regimen (vorinostat, cladribine, and rituximab) in B-cell malignancies. II. Determine the tolerability and toxicities of the SCR ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00764517
Start Date
August 1 2008
End Date
March 1 2017
Last Update
December 11 2017
Active Locations (2)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
2
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850