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Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency
Bu çalışma, D vitamini eksikliği olan yeni tanı almış agresif lenfoma veya kronik lenfositik lösemi (CLL) hastalarında sağkalımı iyileştirmek için Kolekalsiferol (D vitamini) takviyesini inceliyor. İlgili tanısı olan, D vitamini düşük hastalar dahil edilmiştir. Faz uygulanmayan bir çalışmadır; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria:
* Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) that meets disease specific criteria below:
* Study 1 - Aggressive lymphoma
* Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that will be treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone \[R-CHOP\] or equivalent); patients with composite lymphomas can also be enrolled as long as they have large cell component and will be treated with an anthracycline; in addition, patients with "B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and Burkitt lymphoma" or post-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; the patient is permitted to participate in any other therapeutic therapy for their disease as long as it does not concern vitamin D; patients can begin their chemotherapy while awaiting vitamin D results and treatment arm assignment or
* Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) that will be treated with chemotherapy; NOTE: patients can be enrolled up through day 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 according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of:
* Biopsy-proven small lymphocytic lymphoma
* Diagnosis of CLL according to NCI working group criteria as evidenced by all 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-cell antigens (cluster of differentiation \[CD\]19, CD20, or CD23) as well 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 excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(11;14)(immunoglobulin H \[IgH\]/cyclin D 1 \[CCND1\]) on peripheral blood or tissue biopsy or negative immunohistochemical stains 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 after the calcium is corrected with standard of care treatments
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Note: During the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution 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 Criteria:
* Patients with Burkitt lymphoma or any patient receiving rituximab-cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate / ifosfamide, etoposide, high-dose cytarabine (R- CODOXM/IVAC)
* Patients who previously had indolent lymphoma and now at a separate episode have large cell NHL (i.e. transformation