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ATG Based Conditioning Regimen in HLA Related HSCT for Aggressive T-cell Tumors

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ClinicalTrials.gov Identifier: NCT02938741
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
ATG based conditioning regimen in HLA related allogeneic hematopoietic stem cell transplantation for aggressive T-cell tumors: multi-center, open, randomized controlled clinical study

Condition or disease Intervention/treatment Phase
Lymphoblastic Lymphoma Drug: Anti-human Thymoglobulin Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Hematology , Shanghai Jiaotong University Affiliated Shanghai First People's Hospital, Shanghai, China
Study Start Date : October 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: r-ATG Immunosuppressive agents

Rabbit Anti-human Thymoglobulin (r-ATG 2.5 mg/kg×4 days) were extra used in the treatment group.

The conditioning include of Busulfex 3.2mg/kg*4d,CTX 60mg/kg *4d.

Drug: Anti-human Thymoglobulin
r-ATG 2.5MG/KG*4days were used in the conditioning
Other Name: (r-ATG )

Placebo Comparator: placebo

Rabbit Anti-human Thymoglobulin (r-ATG) were not used as intervention in the treatment group.

The conditioning include of Busulfex 3.2mg/kg*4d,CTX 60mg/kg *4d.

Drug: Placebo
r-ATG 2.5MG/KG*4days were not used in the conditioning




Primary Outcome Measures :
  1. relapse free survival(RFS) [ Time Frame: 2 year ]
    PFS were defined as the time from stem-cell infusion to relapse, disease progression from any cause.


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

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

  3. Leukocyte engraftment [ Time Frame: one month ]
    Leukocyte engraftment:(was defined as the first of three consecutive days of peripheral white blood count >1000/ul.

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

  5. Donor chimerism: [ Time Frame: 2 year ]
    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.

  6. Transplant related mortality [ Time Frame: up to 2 year ]
    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
Criteria

Inclusion Criteria:

  • According to the World Health Organization (WHO) classification, diagnosis of T cell tumor of lymphatic system sources (T lymphoblastoid cell lymphoma/leukemia) confirmed by pathological examination,morphology, cytochemistry, immunophenotyping and chromosome examination, molecular biology including complete remission, partial remission.

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. Has enrolled in anther clinical trials 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): NCT02938741


Contacts
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Contact: jun yang, master 18001890183 yangjuan74@hotmail.com
Contact: chun wang, 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   
China
Shanghai First People's HOSPITAL Recruiting
Shanghai, China, 200127
Contact: jun yang, master    18001890183    yangjuan74@hotmai.com   
Contact: chun wang, doctor    13386259777    wangchun2@medmail.com.cn   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: xipeng wang, doctor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications of Results:

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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: NCT02938741     History of Changes
Other Study ID Numbers: 2016KY148
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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
ATG

Additional relevant MeSH terms:
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Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Thymoglobulin
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents