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临床试验/NCT01326728
NCT01326728终止不适用

Study of the Biology and Natural History of Disease Outcomes in Patients Treated With Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
56
试验地点
1
主要终点
Count of Participants With Infection After Allotransplant

研究概览

简要总结

Background:

Allogeneic hematopoietic stem cell transplantation (or allotransplant; donor blood stem cells) have been used with varying degrees of success as an immune therapy for blood-system cancers (leukemias, myelodysplastic syndrome, lymphomas, multiple myeloma, etc.). Some people s cancer remains active (comes back or continues to spread) after an allotransplant, while other peoples cancer disappears and they are hopefully cured. National Institutes of Health (NIH) researchers are studying the reasons for these different treatment outcomes, and trying to develop better cancer treatments for people with active cancer after allotransplant. Researchers are collecting data from people who have had allotransplants for a cancer of the blood, whether or not the cancer is in remission, and from their donors. Those with active cancers may be eligible to participate in one of several NIH studies testing treatments for active cancer after allotransplant.

Objectives:

  • To develop a systematic, comprehensive evaluation of individuals with relapsed malignant blood cancers after allotransplant (and, if available, their donors) to identify potential treatment study options
  • To compare the immune system after allotransplant between people whose cancers are growing with people whose cancers remain in remission.
  • To compare the immune system after cancer relapse/progression treatment between people whose cancer responds to treatment with those whose cancers continue to grow.

Eligibility:

  • Individuals whose blood system cancer grows or comes back after receiving allotransplant treatment.
  • Individuals whose blood system cancer is responding or in remission 100 days or more after receiving allotransplant treatment.
  • Related stem-cell donors of eligible allotransplant recipients.

Design:

  • Participants will be evaluated with a full physical examination, detailed medical history (for recipients, including a history of allotransplant treatment process, side-effects, etc.), and blood tests. Recipients will also have imaging studies, possible tissue biopsies, quality of life questionnaires/assessments, and other tests to evaluate the current state of their cancer, whether active or in remission. In some cases, it may be possible to substitute results from recent tests and/or biopsies.
  • Healthy related donors will have apheresis to provide white blood cells for study and/or for use in potential treatment options. If stem cells would be medically helpful to a recipient, their donors might be asked to take injections of filgrastim before the apheresis procedure to stimulate the production of stem cells for collection.
  • As feasible, all recipients will be asked to return to the NIH for detailed follow-up visits in conjunction with 6, 12, and 24 months post-allotransplant evaluations, and may be monitored between visits.
  • Recipients whose cancers are active and who are found to be eligible for treatment protocols at the NIH will continue to be monitored on this study while participating on treatment protocols. Return visits and follow-up tests for this study will be coordinated with those required by the treatment protocol.
  • Participants may return in the future to be evaluated for new treatment study options (recipients) or additional cell donations for therapy (donors).

详细描述

Background:

  • Cancer relapse is a significant clinical problem following allogeneic hematopoietic stem cell transplantation (allotransplant), affecting up to half of all patients. Effective treatment options are extremely limited and, for most cancers, rarely curative.
  • Several Clinical Center (CC) protocols are evaluating treatment for post-allotransplant relapse. Relapse often progresses quickly; patients require rapid assessment of protocol options in order to expedite initiation of treatment.
  • Basic information is needed to improve management of relapse after allotransplant clinical information regarding risk of relapse and cancer behavior after allotransplant, and information on the biology of relapse after allotransplant in order to identify risk factors, target prevention strategies, detect early relapse and develop effective treatments.

Objectives:

Primary Objective:

To provide a mechanism for systematic, comprehensive evaluation of individuals with relapsed hematologic malignancy after allotransplant and, if available, their donors, to streamline identification of protocol options, enrollment and initiation of therapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Count of Participants With Infection After Allotransplant

时间窗: up to 100 days or more post allotransplant

Count of Participants with Infection After Allotransplant.

Count of Participants With Acute Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant

时间窗: 100 days or more post allotransplant

Acute GVHD is defined as GVHD that presents with signs and symptoms typical of acute GVHD but presenting after day 100 post allotransplant. Clinical Staging Grade 2 ((+) to (+++) Skin; (+) Liver; and (+) Gut) involvement, Grade 3 ((++) to (+++) Skin; (++ to +++) Liver; and (++ to +++) Gut) involvement, and Grade 4 ((++) to (++++) Skin; (++ to ++++) Liver; and (++ to ++++) Gut) involvement.

Immune Suppression

时间窗: up to 100 days or more following transplant

Biological response to agents and or treatments that can lead to bone marrow suppression/ cytopenias and sometimes death.

Overall Survival

时间窗: first day of treatment to the day of death

Overall Survival is the time between the first day of treatment to the day of death.

Time to Progression After Allotransplant

时间窗: first day of treatment to day 100 after allotransplant

Time to Progression is the time between the first day of treatment to day 100 after allotransplant.

Days to Engraftment

时间窗: up to 100 days or more following allotransplant

Number of days for a participant to reach engraftment.

Count of Participants With Chronic Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant

时间窗: 100 days post allotransplant

Mild chronic GVHD involves only 1 or 2 organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites). Moderate GVHD involves at least 1 organ or site with clinically significant but no major disability (max. score of 2 in any affected organ or site), or 3 or more organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites), and a lung score of 1 will also be considered moderate chronic GVHD. Severe chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site). A lung score of 2 or greater will also be considered severe chronic GVHD.

次要结局

  • Number of Participants With Serious and Non-Serious Adverse Events(5 years)

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Ronald Gress, M.D.

Principal Investigator

National Cancer Institute (NCI)

研究点 (1)

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