Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015)
Stopped: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.
South Korea20 participantsStarted 2015-04
Plain-language summary
This study is a prospective multicenter observational study to evaluate the feasibility and the efficacy of the conditioning regimens which are modified by the donor differences and the age of recipients among patients who will receive allogeneic hematopoietic stem cell transplantation in their 1st or 2nd hematologic complete remission (CR).
Who can participate
Age range15 Years
SexALL
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Inclusion Criteria:
* Patients who has been previously diagnosed as one of the following disease;
* Acute lymphoblastic leukemia
* Biphenotypic acute leukemia with Philadelphia-positive chromosome or gene translocation
* Patients whose disease status is one of the following;
* First hematologic complete remission (HCR1)
* Second hematologic complete remission (HCR2)
* 15 years of age and over.
* With a suitable donor (matched sibling, well-matched unrelated, partially-matched unrelated, and haploidentical familial donor)
* Adequate cardiac function (EF\>45% via cardiac scan or EchoCG)
* European Clinical Oncology Group (ECOG) performance status ≥grade 2 or Karnofsky scale \>60% at the time of screening
* All patients give written informed consent according to guidelines at institution's committee on human research.
Exclusion Criteria:
* Acute lymphoblastic leukemia L3 type (Burkitt leukemia/lymphoma)
* Biphenotypic acute leukemia without BCR-ABL1 translocation
* Lymphoblastic lymphoma (bone marrow blast count is below 20% of mononuclear cells of bone marrow aspirate)
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
* Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
* Patients with a diagnos…