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ATG Could Improve the Outcome Of Hematopoietic Stem Cell Transplant in Patients With Highly Aggressive T Cell Tumors (HSCT)

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ClinicalTrials.gov Identifier: NCT02290132
Recruitment Status : Unknown
Verified November 2014 by Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Collaborators:
Tang-Du Hospital
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Information provided by (Responsible Party):
Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Drug: Rabbit Anti-human Thymocyte Globulin (ATG)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 63 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Hematology , Shanghai Jiaotong University Affiliated Shanghai First People's Hospital, Shanghai, China
Study Start Date : August 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : July 2017


Group/Cohort Intervention/treatment
highly aggressive T cell tumors
The study is to research the outcome of Rabbit Anti-human Thymocyte Globulin (ATG)based myeloablative conditioning regimen after allo-HSCT in patients with highly aggressive T-cell tumors.
Drug: Rabbit Anti-human Thymocyte Globulin (ATG)
The conditioning regimen in this study consisted of Rabbit antithymocyte globulin (ATG 2.5 mg/kg×4 days) , total-body irradiation (10 Gy in five fractions), cyclophosphamide (60 mg/kg×2 days) and etoposide or teniposide (30-40mg/kg) .
Other Name: r-ATG




Primary Outcome Measures :
  1. Progress free surviva(PFS) rate at 2 years [ Time Frame: 2 YEARS ]
    PFS were defined as the time from stem-cell infusion to relapse, disease progression,or death from any cause


Secondary Outcome Measures :
  1. Leukocyte engraftment [ Time Frame: 1 MONTH ]
    Leukocyte engraftment:(was defined as the first of three consecutive days of peripheral white blood count >1000/ul.

  2. Platelet engraftment [ Time Frame: 1 MONTH ]
    Platelet engraftment:(was defined as the first of seven consecutive days of platelet counts of >50000/ul.

  3. Donor chimerism: [ Time Frame: 2 YEARS ]
    Quantitative chimerism analyzes were performed using short-tandem-repeat-based polymerase chain reaction technique sat regular intervals for every 4 weeks after allografting in bone marrow.

  4. Relapse incidence (RI) [ Time Frame: 2 YEARS ]
    1. T lymphoblastoid cell lymphoma/leukemia: Bone marrow blasts > 20% 2.peripheral T-cell lymphoma: any increased >50% in the sum of the diameter of any measurable lesions or the appearance of a new lesion.)

  5. Overall survival rate [ Time Frame: 2 YEARS ]
    OS were defined as the time from stem-cell infusion to death from any cause)

  6. Transplant related mortality(TRM) [ Time Frame: 2 YEARS ]
    TRM were defined as death within 100 days of high-dose therapy not related to the disease,relapse or progression



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
According to the World Health Organization (WHO) classification,study population is 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
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290132


Contacts
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Contact: yang jun, master 18001890183 yangjuan74@hotmail.com
Contact: wang chun, doctor 13386259777 wangchun2@medmail.com.cn

Locations
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China, Shanghai
Shanghai First People's HOSPITAL Recruiting
Shanghai, Shanghai, China, 200127
Contact: YANG JUN, master    13564880726    yangjuan74@hotmail.com   
Contact: wang chun, doctor    13386259777    wangchun2@medmail.com.cn   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Tang-Du Hospital
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Chair: liu guohua, doctor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Additional Information:

Publications of Results:
Other Publications:

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Responsible Party: Yang Jun, hematology , Shanghai Jiaotong University affiliated Shanghai First People's Hospital, shanghai, China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02290132    
Other Study ID Numbers: 2013(56)
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
acute lymphoblastic leukemia
lymphoblastic lymphoma
stem-cell transplant
T-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Thymoglobulin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents