Status:
UNKNOWN
ATG Could Improve the Outcome Of Hematopoietic Stem Cell Transplant in Patients With Highly Aggressive T Cell Tumors
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Tang-Du Hospital
The First Affiliated Hospital of Soochow University
Conditions:
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Eligibility:
All Genders
18-60 years
Brief Summary
The clinical application and effect of ATG based myeloablative conditioning regimen after allogeneic hematopoietic stem cell transplantation in adult patients with aggressive T-cell lymphomas.
Detailed Description
Aggressive T-cell lymphomas (ATCLs), including peripheral T-cell lymphoma and T lymphoblastoid cell lymphoma/leukemia, represent 10% to 15% of non-Hodgkin's lymphomas (NHLs) in adults(1). ATCLs show a...
Eligibility Criteria
Inclusion
- According to the World Health Organization (WHO) classification, diagnosis of T cell tumor of lymphatic system sources (including peripheral T-cell lymphoma and T lymphoblastoid cell lymphoma/leukemia) confirmed by pathological examination, morphology, cytochemistry, immunophenotyping and chromosome examination, molecular biology including complete remission, partial remission, relapse after remission or refractory recurrent invasive patients
- 18 to 60 years old. Male or female
- Performance status scores no more than 2 (ECOG criteria).
- Adequate organ function as defined by the following criteria:
- alanine transaminase （ALT）, aspartate transaminase（AST） and total serum bilirubin \<2×ULN (upper limit of normal)
- Serum creatinine and blood urea nitrogen(BUN) \<1.25×ULN.
- Adequate cardiac function without acute myocardial infarction, arrhythmia or atrioventricular block, heart failure, active rheumatic heart disease and cardiac dilatation(the patients has been improved after treatment of the disease and are not expected to affect transplant can include in the study).
- Absence of any other contraindications of stem cell transplantation.
- Willingness and ability to perform HSCT.
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion
- Presence of any condition inappropriate for HSCT.
- Life expectancy \< 3 months because of other severe diseases.
- Presence of any fatal disease, including respiratory failure, heart failure, liver or kidney function failure et al.
- Uncontrolled infection.
- Pregnancy or breastfeeding. 6．Has enrolled in anther clinical trials 7．Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT02290132
Start Date
August 1 2013
End Date
July 1 2017
Last Update
November 13 2014
Active Locations (1)
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1
Shanghai First People's HOSPITAL
Shanghai, Shanghai Municipality, China, 200127