NCT01991457已完成2 期
Single Arm Phase II Study of Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia (ALL) in Older Patients Using Fludarabine and Total Body Irradiation (FluTBI) Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Disease-free Survival
研究概览
简要总结
The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The primary objective is to establish the efficacy of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease Criteria:
- •ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration.
- •Philadelphia chromosome positive ALL is allowed.
- •Lymphoid blastic crisis of CML will be included (provided that patients achieve CR).
- •Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen.
- •Organ Function Criteria: All organ function testing should be done within 28 days of study registration.
- •Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
- •Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted.
- •Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:
- •CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL).
- •Serum bilirubin 2.0 g/dL
- •Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN
- •Alkaline phosphatase 2.5 ULN
- •Performance status: Karnofsky ≥ 70%
- •Consent: Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability,in the opinion of the principal investigator, to comply with all the requirements of the study.
- •Presence of a willing adult HLA-matched sibling (excluding identical twin) or HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors will be evaluated for eligibility and suitability per the standard of care according to the FACT and NMDP guidelines.
排除标准
- •Non-compliant to medications.
- •No appropriate caregivers identified.
- •HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive
- •Active life-threatening cancer requiring treatment other than ALL
- •Uncontrolled medical or psychiatric disorders.
- •Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration.
- •Active central nervous system (CNS) leukemia
- •Preceding allogeneic HSCT
- •Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed.
研究组 & 干预措施
Treatment
Other
Fludarabine, Total Body Irradiation (TBI) Fludarabine: 40 mg/m2 X 4 days TBI: TBI 2 Gy 2 times a day X 3 days
干预措施: Fludarabine (Drug)
Treatment
Other
Fludarabine, Total Body Irradiation (TBI) Fludarabine: 40 mg/m2 X 4 days TBI: TBI 2 Gy 2 times a day X 3 days
干预措施: Total Body Irradiation (Procedure)
结局指标
主要结局
Percentage of Subjects Disease-free Survival
时间窗: 2 years post-transplant
Percentage of patients without relapse of disease at 2 years
次要结局
- Percentage of Subjects That Survived(2 years post-transplant)
- Number of Subjects With Regimen Related Toxicity(Within first 100 days post-transplant)
- Percentage of Subjects With Acute GVHD(2 years post transplant)
- Number of Subjects With Platelet Engraftment(Within 100 days post transplant)
- Percentage of Subjects With Chronic GVHD(2 years post transplant)
- Time to Neutrophil Engraftment(Within the first 100 days)
- Number of Patients With Immune Reconstitution(1 year post transplant)
- Percentage of Subjects With Relapse(2 Years post-transplant)
研究者
Omer Jamy
Primary Investigator
University of Alabama at Birmingham
研究点 (1)
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