Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 565
- 试验地点
- 10
- 主要终点
- Treatment free status (Study II)
研究概览
简要总结
This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.
详细描述
PRIMARY OBJECTIVES:
I. To determine if vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated diffuse large B-cell lymphoma (DLBCL) can improve event free survival at 12 months to be equivalent to that of a control population of vitamin D sufficient patients. (Study I) II. To assess the percentage of patients requiring treatment with conventional therapy at 36 in months in vitamin D insufficient patients with early stage chronic lymphocytic leukemia (CLL) being managed with observation who undergo vitamin D replacement. (Study II)
SECONDARY OBJECTIVES:
I. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on overall survival. (Study I) II. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on event free survival. (Study I) III. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated T cell lymphoma on event free and overall survival. (Study I) IV. To assess the effect of vitamin D replacement in vitamin D insufficient CLL patients on Bio-r response rate and overall response rate. (Study II) V. To assess time to treatment and overall survival in vitamin D insufficient CLL patients who received vitamin D replacement. (Study II)
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (cholecalciferol)
Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol PO once weekly for 12 weeks and then once monthly for a total of 36 months.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (cholecalciferol)
Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol PO once weekly for 12 weeks and then once monthly for a total of 36 months.
干预措施: Cholecalciferol (Dietary Supplement)
结局指标
主要结局
Treatment free status (Study II)
时间窗: At 36 months
The proportion of successes will be estimated separately in the groups by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated by the exact binomial method.
Event free survival (EFS) (Study I)
时间窗: Time from study registration to lymphoma progression, initiation of new anti-lymphoma therapy after completion or cessation of the original anthracycline based treatment, or death due to any cause, assessed at 12 months
The proportion of successes will be estimated separately in the groups by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated by the exact binomial method.
次要结局
- Bio-R response rate (Study II)(Up to 5 years)
- EFS time (Study I)(From study registration to lymphoma progression, initiation of new anti-lymphoma therapy after completion or cessation of the original anthracycline based treatment, or death due to any cause, assessed up to 5 years)
- Overall response rate (Study II)(Up to 5 years)
- OS (Study II)(From registration to death due to any cause, assessed up to 5 years)
- Overall survival (OS) time (Study I)(From registration to death due to any cause, assessed up to 5 years)
- Time to first treatment (Study II)(From study registration to initiation of anti-CLL therapy, assessed up to 5 years)