ATG Based Conditioning Regimen in HLA Related HSCT for Aggressive T-cell Tumors
Hematology , Shanghai Jiaotong University Affiliated Shanghai First People's Hospital, Shanghai, China
1 other identifier
interventional
130
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2016
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 16, 2016
CompletedFirst Posted
Study publicly available on registry
October 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 25, 2016
October 1, 2016
5.2 years
October 16, 2016
October 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
relapse free survival(RFS)
PFS were defined as the time from stem-cell infusion to relapse, disease progression from any cause.
2 year
Secondary Outcomes (6)
Progress free survival (PFS) rate
2 years
Overall survival rate
2 years
Leukocyte engraftment
one month
Platelet engraftment
one month
Donor chimerism:
2 year
- +1 more secondary outcomes
Study Arms (2)
r-ATG Immunosuppressive agents
EXPERIMENTALRabbit 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.
placebo
PLACEBO COMPARATORRabbit 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.
Interventions
r-ATG 2.5MG/KG\*4days were used in the conditioning
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shanghai First People's HOSPITAL
Shanghai, Shanghai Municipality, 200127, China
Shanghai First People's HOSPITAL
Shanghai, 200127, China
Related Publications (9)
Rudiger T, Weisenburger DD, Anderson JR, Armitage JO, Diebold J, MacLennan KA, Nathwani BN, Ullrich F, Muller-Hermelink HK; Non-Hodgkin's Lymphoma Classification Project. Peripheral T-cell lymphoma (excluding anaplastic large-cell lymphoma): results from the Non-Hodgkin's Lymphoma Classification Project. Ann Oncol. 2002 Jan;13(1):140-9. doi: 10.1093/annonc/mdf033.
PMID: 11863096RESULTVose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008 Sep 1;26(25):4124-30. doi: 10.1200/JCO.2008.16.4558. Epub 2008 Jul 14.
PMID: 18626005RESULTMohty M. Mechanisms of action of antithymocyte globulin: T-cell depletion and beyond. Leukemia. 2007 Jul;21(7):1387-94. doi: 10.1038/sj.leu.2404683. Epub 2007 Apr 5.
PMID: 17410187RESULTDu K, Hu Y, Wu K, Huang H. Long-term outcomes of antithymocyte globulin in patients with hematological malignancies undergoing myeloablative allogeneic hematopoietic cell transplantation: a systematic review and meta-analysis. Clin Transplant. 2013 Mar-Apr;27(2):E91-E100. doi: 10.1111/ctr.12091. Epub 2013 Feb 6.
PMID: 23383989RESULTGrullich C, Ziegler C, Finke J. Rabbit anti T-lymphocyte globulin induces apoptosis in peripheral blood mononuclear cell compartments and leukemia cells, while hematopoetic stem cells are apoptosis resistant. Biol Blood Marrow Transplant. 2009 Feb;15(2):173-82. doi: 10.1016/j.bbmt.2008.11.014.
PMID: 19167677RESULTLiu H, Qin Y, Wang X, Xie K, Yang Y, Zhu J, Zhao C, Wang C. Polyclonal rabbit antithymocyte globulin induces apoptosis and has cytotoxic effects on human leukemic cells. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):345-54. doi: 10.1016/j.clml.2012.05.006. Epub 2012 Jun 6.
PMID: 22677206RESULTMeijer E, Cornelissen JJ, Lowenberg B, Verdonck LF. Antithymocyteglobulin as prophylaxis of graft failure and graft-versus-host disease in recipients of partially T-cell-depleted grafts from matched unrelated donors: a dose-finding study. Exp Hematol. 2003 Nov;31(11):1026-30. doi: 10.1016/s0301-472x(03)00204-2.
PMID: 14585365RESULTYang J, Cai Y, Jiang JL, Wan LP, Yan SK, Wang C. Anti-thymocyte globulin could improve the outcome of allogeneic hematopoietic stem cell transplantation in patients with highly aggressive T-cell tumors. Blood Cancer J. 2015 Jul 31;5(7):e332. doi: 10.1038/bcj.2015.54.
PMID: 26230956RESULTPrzepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.
PMID: 7581076RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
xipeng wang, doctor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hematology , Shanghai Jiaotong University Affiliated Shanghai First People's Hospital, Shanghai, China
Study Record Dates
First Submitted
October 16, 2016
First Posted
October 19, 2016
Study Start
October 1, 2016
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
October 25, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share