ATG Could Improve the Outcome Of Hematopoietic Stem Cell Transplant in Patients With Highly Aggressive T Cell Tumors (HSCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment|
|Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma||Drug: Rabbit Anti-human Thymocyte Globulin (ATG)|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||63 participants|
|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|
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
- 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
- Leukocyte engraftment [ Time Frame: 1 MONTH ]Leukocyte engraftment:(was defined as the first of three consecutive days of peripheral white blood count >1000/ul.
- Platelet engraftment [ Time Frame: 1 MONTH ]Platelet engraftment:(was defined as the first of seven consecutive days of platelet counts of >50000/ul.
- 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.
- 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.）
- Overall survival rate [ Time Frame: 2 YEARS ]OS were defined as the time from stem-cell infusion to death from any cause)
- 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
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
|Contact: yang jun, firstname.lastname@example.org|
|Contact: wang chun, email@example.com|
|Study Chair:||liu guohua, doctor||Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine|