Phase
Condition
Lymphoma, B-cell
Chronic Lymphocytic Leukemia
T-cell Lymphoma
Treatment
Laboratory Biomarker Analysis
Cholecalciferol
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) thatmeets disease specific criteria below:
Study 1 - Aggressive lymphoma
Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that willbe treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone [R-CHOP] orequivalent); patients with composite lymphomas can also be enrolled as long asthey have large cell component and will be treated with an anthracycline; inaddition, patients with "B cell lymphoma, unclassifiable, with featuresintermediate between diffuse large B cell lymphoma and Burkitt lymphoma" orpost-transplant DLBCL are also eligible as long as they meet other criteria;patients with typical Burkitt lymphoma are not eligible
NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; thepatient is permitted to participate in any other therapeutic therapy fortheir disease as long as it does not concern vitamin D; patients can begintheir chemotherapy while awaiting vitamin D results and treatment armassignment or
Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) thatwill be treated with chemotherapy; NOTE: patients can be enrolled up throughday 1 of cycle 3 of therapy; this includes the following disease types:
Peripheral T cell lymphoma, unspecified
Anaplastic large cell lymphoma (T and null cell type)
Extranodal NK/T-cell lymphoma, nasal type
Enteropathy-type T-cell lymphoma
Hepatosplenic T-cell lymphoma
Subcutaneous panniculitis-like T-cell lymphoma
Angioimmunoblastic T-cell lymphoma
Anaplastic large cell lymphoma - primary cutaneous type and
Willing to provide tissue for correlative research purposes
Study 2 - CLL/SLL
Newly diagnosed (< 12 months from pre-registration on this study) CLL accordingto the National Cancer Institute (NCI) criteria or SLL according to the WorldHealth Organization (WHO) criteria; this includes previous documentation of:
Biopsy-proven small lymphocytic lymphoma
Diagnosis of CLL according to NCI working group criteria as evidenced byall of the following:
Peripheral blood lymphocyte count of > 5,000/mm^3; if present,prolymphocytes should be < 55%
Immunophenotyping consistent with CLL defined as:
The predominant population of lymphocytes share both B-cellantigens (cluster of differentiation [CD]19, CD20, or CD23) aswell as CD5 in the absence of other pan-T-cell markers (CD3,CD2, etc.)
Dim surface immunoglobulin expression
Restricted surface kappa or lambda light chain expression
Before diagnosing CLL or SLL, mantle cell lymphoma must be excludedby demonstrating a negative fluorescent in situ hybridization (FISH)analysis for t(11;14)(immunoglobulin H [IgH]/cyclin D 1 [CCND1]) onperipheral blood or tissue biopsy or negative immunohistochemicalstains for cyclin D1 on involved tissue biopsy
Rai stage 0 or 1
Previously untreated
Asymptomatic with the plan for observation
Life expectancy of at least 24 months
Willing to provide tissue for correlative research purposes
Both Studies:
Capable of swallowing intact study medication capsules
Serum calcium < 11 mg/dL; note: patients with hypercalcemia can be enrolled afterthe calcium is corrected with standard of care treatments
Willing to return to enrolling institution for follow-up (during the activemonitoring phase of the study)
Note: During the Active Monitoring Phase of a study (i.e., active treatment andobservation), participants must be willing to return to the consentinginstitution for follow-up
Willing to provide blood samples for correlative research purposes
Vitamin D level (25 hydroxy D2 + hydroxyl D3) confirmed by central laboratory review
Exclusion
Exclusion Criteria:
Patients with Burkitt lymphoma or any patient receiving rituximab-cyclophosphamide,vincristine, doxorubicin, high-dose methotrexate / ifosfamide, etoposide, high-dosecytarabine (R- CODOXM/IVAC)
Patients who previously had indolent lymphoma and now at a separate episode havelarge cell NHL (i.e. transformation
Study Design
Study Description
Connect with a study center
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United StatesSite Not Available
Emory University/Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesSite Not Available

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