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临床试验/IRCT138706061030N2
IRCT138706061030N2已完成2 期

Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H

Tehran University of Medical Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 65 years(—)
性别
All

入选标准

  • Inclusion Criteria:
  • Ages 5-50 years
  • Acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
  • Second remission (CR2) in standard risk patients or CR1 in cases with high-risk features (poor cytogenetic changes or secondary to myelodysplastic syndrome)
  • Unavailability of HLA identical related donor or matched unrelated donor.
  • Unavailability of other therapeutic intervention that prolongs patient survival.
  • No history of allergy to CAMPATH.
  • The donor must be haploidentical with the recipient.
  • Weight greater than or equal to 18 kg.
  • Age between 2 and 60 years old.
  • Negative two-way WBC crossmatch with the recipient.

排除标准

  • Major anticipated illness or organ failure incompatible with survival from transplantation.
  • Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the transplantation procedure unlikely and making informed consent impossible.
  • HIV positive
  • Active infection
  • Positive pregnancy test for women of childbearing age.
  • Left ventricular ejection fraction less than 40%
  • AST/SGOT greater than 20 x ULN (CTCAE grade IV v3.0)
  • Bilirubin greater than 10 x ULN (CTCAE grade IV v3.0)
  • Creatinine greater than 6 x ULN (CTCAE grade IV v 3.0)
  • Pregnant or lactating
  • Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension)
  • Sickling hemoglobinopathies including HbSS, HbAS, HbSC
  • HBsAg positive
  • CMV positive (for CMV negative recipients)

研究者

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