KCT0004030招募中未知
Allogeneic stem cell transplantation with 3-days busulfan plus fludarabine as conditioning in patients with relapsed or refractory T-, NK/T-cell lymphomas
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1. Age 19 - 65
- •2. Histologically confirmed T or NK(Natural Killer) cell lymphomas :
- •- anaplastic large cell lymphoma
- •- angioimmunoblastic T-cell lymphoma,
- •- peripheral T-cell lymphoma, NOS(Not Otherwise Specified)
- •- extradonal NK(Natural Killer)/T-cell lymphoma, nasal type
- •3. Relapsed after or refractory to one or more of previous
- •chemotherapy including frontline autologous HSCT(Hematopoietic Stem Cell Transplant).
- •4. At least one measured lesion using conventional CT or PET CT at the time of relapse after or refractory to one or more of previous chemotherapy and before salvage chemotherapy
- •5. Complete or Partial response after short cycles of salvage chemotherapy
- •6. Patients who have HLA(human leukocyte antigen) full-match (8/8 in HLA(human leukocyte antigen)-A,
- •B, C, DR by DNA high-resolution technique) or one-locus mismatch
- •(7/8) sibling, or unrelated bone marrow or peripheral blood or cord blood stem cell donors
- •7. ECOG(Eastern Cooperative Oncology Group ) performance status = 2
- •8. Charlson Comorbidity Index (CCI) before HSCT(Hematopoietic Stem Cell Transplant) = 3
- •9. Adequate renal function : serum creatinine level < 2.0 mg/dL
- •10. Adequate liver function :
- •– Transaminase (AST(aspartate aminotransferase)/ALT(alanine aminotransaminase)) < 3 X upper normal value
- •(or < 5 x upper normal value in the presence of lymphoma involvement of the liver)
- •– Total bilirubin < 2 X upper normal value
- •(or < 5 x upper normal value in the presence of NK(Natural Killer)/T involvement of the liver)
- •11. Cardiac ejection fraction = 50 % as measured by MUGA(multigated acquisition)
- •or 2D ECHO(echocardiography) without clinically significant abnormality
- •12. No clinically significant infection
- •13. No clinically significant bleeding symptoms or sign
- •14. Patients who decided to participate in this study and signed for a
- •written consent
排除标准
- •1. Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma,
- •Primary cutaneous CD30+ T cell disorders
- •Mycosis fungoides, Sezary Syndrome
- •2. Patients who have previously performed Allo-HSCT(Hematopoietic Stem Cell Transplant)
- •3. T cell lymphoma with primary central nervous system (CNS)
- •Involvement.
- •** However, patients who have only had prophylactic
- •intrathecal or intravenous chemotherapy against CNS disease are eligible.
- •4. Patients with a known history of HIV(human immunodeficiency virus) seropositivity or HCV(hepatitis C virus) (+).
- •** Patients with HBV are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier or
- •prevent HBV(hepatitis B virus) reactivation during whole treatment period.
- •5. Any other malignancies within the past 5 years
- •** Except curatively treated non-melanoma skin cancer or in situ
- •carcinoma of cervix uteri
- •6. Ejection fraction < 50% by a echocardiography
- •7. FEV1(Forced Expiratory Volume in One Second) <60% or DLCO(Pulmonary diffusion capacity of carbon monoxide) <60% by a pulmonary function test
- •8. ECOG(Eastern Cooperative Oncology Group ) performance status 3 or 4
- •9. Combined serious medical problem or disease
- •- Serious or unstable heart disease although proper treatment
- •- Myocardial infarction in recent 3 months
- •- Underlying serious neurologic or psychiatric disease including
- •dementia or seizure
- •- Active uncontrolled infection including hepatitis B and C
- •- Serious other medical problems observed by the doctors in charge
- •of the patient
- •10. Pregnant or lactating women, women or men of childbearing potential not employing adequate contraception
- •11. History of hypersensitivity, allergy or intolerance to the study drug
- •12. History of fatal hemolytic anemia due to the study drug
研究者
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