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临床试验 NCT03870750 针对造血和淋巴细胞肿瘤，非肿瘤性血液和淋巴细胞疾病目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases
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临床试验NCT03870750旨在研究支持治疗，主要针对造血和淋巴细胞肿瘤，非肿瘤性血液和淋巴细胞疾病。这是一项II期 (第二期) III期 (第三期) 干预性研究试验，目前试验状态为进行中但不再招募。试验始于2019年8月15日，计划招募458名患者。该研究由Fred Hutchinson Cancer Center主导，预计于2025年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年6月18日。
简要概括
This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. One approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses on managing multiple diseases, other than cancer, such as heart or lung diseases through physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education. Giving SPC, CMC, or a combination of both may work better in improving quality of life and survival after a donor stem cell transplant compared to standard of care in patients with blood diseases.
详细描述
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients undergo SPC on days -15 before to +56 after transplant.
ARM II: Patients undergo a CMC program on days -15 before to +56 after transplant.
ARM III: Patients undergo interventions as outlined in Arm I and Arm II.
ARM IV: Patients receive standard of care.
In all arms, patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment and 30, 90, 180, and 365 days post HCT. In all arms patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
官方标题
Seamless Phase II-Phase III Randomized Clinical Trial to Identify and Confirm the Most Promising Novel Intervention to Alleviate Morbidity and Mortality After Allogeneic Hematopoietic Cell Transplantation Among Older, Medically Infirm, or Frail Patients With Hematological Diseases
疾病
造血和淋巴细胞肿瘤非肿瘤性血液和淋巴细胞疾病其他研究标识符
- RG1004746
- NCI-2019-01097 (注册标识符) (CTRP (Clinical Trial Reporting Program))
- 9885 (其他标识符) (Fred Hutch/University of Washington Cancer Consortium)
- R01CA227092 (美国 NIH 拨款/合同)
NCT编号
实际开始日期
2019-08-15
最近更新发布
2025-06-18
预计完成日期
2025-12-31
计划入组人数
458
研究类型
干预性研究
试验分期 (阶段)
II期 (第二期)
III期 (第三期)
III期 (第三期)
试验状态
进行中但不再招募
主要目的
支持治疗
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Arm I (SPC) Patients undergo SPC on days -15 before to +56 after transplant. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. | Supportive Palliative Care focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects 同种异体造血干细胞移植 Undergo HCT 问卷管理 Ancillary studies 生活质量评估 Ancillary studies 调查管理 Complete surveys |
实验性Arm II (CMC) Patients undergo a CMC program on days -15 to 56. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. | 临床管理 physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education 同种异体造血干细胞移植 Undergo HCT 问卷管理 Ancillary studies 生活质量评估 Ancillary studies 调查管理 Complete surveys |
实验性Arm III (SPC and CMC) Patients undergo interventions as outlined in Arm I and Arm II. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. | Supportive Palliative Care focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects 临床管理 physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education 同种异体造血干细胞移植 Undergo HCT 问卷管理 Ancillary studies 生活质量评估 Ancillary studies 调查管理 Complete surveys |
阳性对照Arm IV (standard of care) Patients receive standard of care. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. | 最佳实践 Given standard of care 问卷管理 Ancillary studies 生活质量评估 Ancillary studies 调查管理 Complete surveys |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Improvement in health-related quality of life (HRQOL) (Phase II) | The arm with the largest mean change in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) from baseline to day 90. The Wilcoxon rank-sum test will be used to compare change in FACT-BMT between arms, and this will also be the test to be used in computation of the conditional power at the end of phase II. | First 90 days after HCT |
Survival after hematopoietic cell transplantation (HCT) (Phase III) | At 1 year after HCT | |
Change in HRQOL (Phase III) | Will be measured by the FACT-BMT. | Baseline to 90 days post-HCT |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Rate of overall survival | Overall survival will be compared between each of the experimental arms and the usual care only (UCO) arm using the log-rank test. Arms that do not survive the screening phase will also be included for comparison. | Up to 1 year |
Non-relapse mortality | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; analysis of variance (ANOVA) or Kruskal-Wallis test for comparisons involving more than two groups). Will use generalized estimating equations (GEEs) approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | At 90 days and up to 1 year |
Cumulative incidence of relapse | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 1 year |
Relapse-free survival | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 1 year |
Cumulative incidence of frailty | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 1 year |
Cumulative incidence of disability | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 1 year |
Frequency of hospitalization | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 90 days after HCT |
Duration of each hospitalization | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 90 days after HCT |
Number of admissions to intensive care unit | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 90 days after HCT |
Duration of admissions to intensive care unit | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 90 days after HCT |
Days out of hospital alive | Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation. | Up to 90 days after HCT |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
20 Years
适龄性别
全部
Vulnerable patients as defined by one or more of the following criteria
- Age 65 years or older
- Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of >= 3 (for patients that could be 20 years old and older)
- Having frailty as determined by walk speed of < 0.8 m/s using 4-meter walk test (for patients 50 years old and older)
Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
Willing and able to provide informed consent
Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
Able to exercise at low to moderate intensity, specifically taking into consideration the rare circumstances where subjects are not able to exercise due to either birth deformity or prior traumatic injury that affects their gait
Adequate cardiopulmonary reserve, as judged by data from the patient's electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment
- Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
- Participation in another intervention clinical trial with HRQOL as a primary endpoint
- Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
- Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)
Fred Hutchinson Cancer Center- 国家癌症研究所3028 个活跃的临床试验可供探索
- National Institutes of Health (NIH)
没有联系数据。
11 位于 1 个国家/地区的研究中心
California
Stanford Cancer Institute Palo Alto, Palo Alto, California, 94304, United States
University of California San Francisco, San Francisco, California, 94143, United States
Michigan
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States
Minnesota
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, 55455, United States
Mayo Clinic, Rochester, Minnesota, 55905, United States
New York
Northwell Health Cancer Institute, New Hyde Park, New York, 11042, United States
Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, 44195, United States
Oregon
Oregon Health and Science University, Portland, Oregon, 97239, United States
Tennessee
Vanderbilt University, Nashville, Tennessee, 37232, United States
Texas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, 77030, United States
Washington
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States