Acute Lymphoblastic LeukemiaHSCTNCT02290132
ATG Could Improve the Outcome Of Hematopoietic Stem Cell Transplant in Patients With Highly Aggressive T Cell Tumors
An observational study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- What is being tested?
- Rabbit Anti-human Thymocyte Globulin (ATG)
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Jul 2017
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First People's HOSPITAL
Shanghai, Shanghai Municipality, 200127
YANG JUN, master, 13564880726, yangjuan74@hotmail.com
wang chun, doctor, 13386259777, wangchun2@medmail.com.cn
About this study
Official title: Hematology , Shanghai Jiaotong University Affiliated Shanghai First People's Hospital, Shanghai, China
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.
Read the 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 worse prognosis than that of B-cell lymphomas. Myeloablative allogeneic stem cell transplantation (allo-SCT) may be the only way to cure these patients, but the recurrence of the primary disease after transplantation is still an important prognostic factor (2). Optimizing the conditioning regimen is always the research hot topics in hematology fields. Polyclonal anti-thymocyte globulin (rabbit anti-thymocyte globulin, r-ATG) are currently used to prevent graft-versus -host(GVHD) disease in allogeneic stem cell transplantation, and also widely used for the prevention and treatment of acute rejection after solid organ transplant because of its strong immunomodulatory effects. ATG is used in allogeneic SCT for the prophylaxis of graft versus host disease by in vivo T cell depletion, including the complement-dependent cytotoxic response, antibody-dependent cell-mediated cytotoxicity, the opsonophagocytic role of phagocytic cells and induced apoptosis(3). But some scholars reported the ATG delayed immune reconstitution and hematologic reconstitution and leaded to the increase of the incidence of virus and fungal infections after transplantation. But it is often curable and does not affect the overall survival and quality of life of the patients (4). Because of its strong immune suppression and regulation, also on the basis of the above facts, ATG as GVHD prophylaxis is generally limited to the unrelated donor, or human leukocyte antigen（HLA）-mismatched related donor transplantation. But There are many issues still need to be studied. ATG has shown efficacy in preventing acute GVHD（aGVHD) in allo-SCT, but its efficacy in chronic GVHD (cGVHD) and long-term outcomes remains controversial. A systematic review and meta-analysis from Du k et al（5） reported that prophylactic use of ATG exerted a favorable effect in reducing cGVHD without survival impairment in a long term, although a higher relapse rate is a major threat.
Does the ATG also have the killing effect on the tumor cells of the lymphatic system? The vitro studies have confirmed this point recently. Grüllich(6) et al and the investigators study(7) both found that ATG can inhibit the proliferation and induce high level of apoptosis in the human lymphoblastic cell lines, such as Jurkat, Daudi, DG-75 , and myeloblastic cell lines K562, HL-60, KG1, and U937. ATG also has pro-apoptotic activity against the majority of primary leukemia cells, particularly those cells from lymphatic origin. In addition, ATG will not result in apoptosis of normal hematopoietic cells. Low-dose ATG can also stimulate normal hematopoietic colony growth. Therefore, ATG may be used as anti-lymphocyte tumor bio-therapeutics (such as rituximab) to increase the role of chemo-radiotherapy in the conditioning regimen. And ATG can remove the residual tumor lesions, which reduced the rate of tumor recurrence after transplantation. Although the vitro studies have clarified the role of ATG on the tumor cells of the lymphatic system, but no relevant reports on the anti-tumor effect of ATG in allo-SCT have been published. Further clinical observation need to be conducted.
As noted earlier, a higher relapse rate may be a major threat after ATG use（5）.In China, the conventional dose of 2.5mg/kg/day, 2-3 days of Thymoglobulin is commonly used as GVHD prophylaxis in the unrelated donor, or HLA-mismatched related donor transplantation but not in the HLA matched related donor transplantation (8). In order to observe the anti-tumor effect of this conditioning regimen in the aggressive T-cell lymphomas patients(including peripheral T-cell lymphoma and T lymphoblastoid cell lymphoma/leukemia, complete remission, partial remission, relapse after remission or refractory recurrent invasive patients), the investigators improved the drugs of conditioning regimen and increased the Thymoglobulin dose in the conditioning regimen for four days 10mg/kg total even in the HLA matched related donor transplantation. The purpose of this clinical trial is to reduce the incidence of GVHD at the same time does not increase the recurrence of the primary disease. The investigators expect that this ATG based conditioning regimen does play anti-tumor effect, reduce primary disease recurrence after transplantation, improve disease-free survival (DFS) and overall survival rate (OS) , as well as reduce the incidence and severity of GVHD, but the incidence of infection need to be observed.
- Being tested
- Rabbit Anti-human Thymocyte Globulin (ATG)
- Keywords
- acute lymphoblastic leukemia, lymphoblastic lymphoma, stem-cell transplant, T-cell lymphoma
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabbit Anti-human Thymocyte Globulin (ATG)Drug
Also called r-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) .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rabbit Anti-human Thymocyte Globulin (ATG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free surviva(PFS) rate at 2 years
PFS were defined as the time from stem-cell infusion to relapse, disease progression,or death from any cause
Measured: 2 YEARS
Secondary outcomes (6)
Leukocyte engraftment
Leukocyte engraftment:(was defined as the first of three consecutive days of peripheral white blood count >1000/ul.
Measured: 1 MONTH
Platelet engraftment
Platelet engraftment:(was defined as the first of seven consecutive days of platelet counts of >50000/ul.
Measured: 1 MONTH
Donor chimerism:
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.
Measured: 2 YEARS
Relapse incidence (RI)
- 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.）
Measured: 2 YEARS
Overall survival rate
OS were defined as the time from stem-cell infusion to death from any cause)
Measured: 2 YEARS
Transplant related mortality(TRM)
TRM were defined as death within 100 days of high-dose therapy not related to the disease,relapse or progression
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Principal investigator, Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- liu guohua, doctor, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290132
- Sponsor's protocol ID
- 2013（56）
- Acronym
- HSCT
- Status last verified
- Nov 2014
- First submitted
- 13 Oct 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11863096Vose 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.
PubMed 18626005Mohty 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.
PubMed 17410187Du 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.
PubMed 23383989Grullich 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.
PubMed 19167677Meijer 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.
PubMed 14585365Przepiorka 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.
PubMed 7581076Liu 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.
PubMed 22677206
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematology , Shanghai Jiaotong University Affiliated Shanghai First People's Hospital, Shanghai, China
- ClinicalTrials.gov ID
- NCT02290132
- Acronym / sponsor ID
- HSCT / 2013（56）
- Keywords
- acute lymphoblastic leukemia, lymphoblastic lymphoma, stem-cell transplant, T-cell lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Tang-Du Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 worse prognosis than that of B-cell lymphomas. Myeloablative allogeneic stem cell transplantation (allo-SCT) may be the only way to cure these patients, but the recurrence of the primary disease after transplantation is still an important prognostic factor (2). Optimizing the conditioning regimen is always the research hot topics in hematology fields. Polyclonal anti-thymocyte globulin (rabbit anti-thymocyte globulin, r-ATG) are currently used to prevent graft-versus -host(GVHD) disease in allogeneic stem cell transplantation, and also widely used for the prevention and treatment of acute rejection after solid organ transplant because of its strong immunomodulatory effects. ATG is used in allogeneic SCT for the prophylaxis of graft versus host disease by in vivo T cell depletion, including the complement-dependent cytotoxic response, antibody-dependent cell-mediated cytotoxicity, the opsonophagocytic role of phagocytic cells and induced apoptosis(3). But some scholars reported the ATG delayed immune reconstitution and hematologic reconstitution and leaded to the increase of the incidence of virus and fungal infections after transplantation. But it is often curable and does not affect the overall survival and quality of life of the patients (4). Because of its strong immune suppression and regulation, also on the basis of the above facts, ATG as GVHD prophylaxis is generally limited to the unrelated donor, or human leukocyte antigen（HLA）-mismatched related donor transplantation. But There are many issues still need to be studied. ATG has shown efficacy in preventing acute GVHD（aGVHD) in allo-SCT, but its efficacy in chronic GVHD (cGVHD) and long-term outcomes remains controversial. A systematic review and meta-analysis from Du k et al（5） reported that prophylactic use of ATG exerted a favorable effect in reducing cGVHD without survival impairment in a long term, although a higher relapse rate is a major threat.
Does the ATG also have the killing effect on the tumor cells of the lymphatic system? The vitro studies have confirmed this point recently. Grüllich(6) et al and the investigators study(7) both found that ATG can inhibit the proliferation and induce high level of apoptosis in the human lymphoblastic cell lines, such as Jurkat, Daudi, DG-75 , and myeloblastic cell lines K562, HL-60, KG1, and U937. ATG also has pro-apoptotic activity against the majority of primary leukemia cells, particularly those cells from lymphatic origin. In addition, ATG will not result in apoptosis of normal hematopoietic cells. Low-dose ATG can also stimulate normal hematopoietic colony growth. Therefore, ATG may be used as anti-lymphocyte tumor bio-therapeutics (such as rituximab) to increase the role of chemo-radiotherapy in the conditioning regimen. And ATG can remove the residual tumor lesions, which reduced the rate of tumor recurrence after transplantation. Although the vitro studies have clarified the role of ATG on the tumor cells of the lymphatic system, but no relevant reports on the anti-tumor effect of ATG in allo-SCT have been published. Further clinical observation need to be conducted.
As noted earlier, a higher relapse rate may be a major threat after ATG use（5）.In China, the conventional dose of 2.5mg/kg/day, 2-3 days of Thymoglobulin is commonly used as GVHD prophylaxis in the unrelated donor, or HLA-mismatched related donor transplantation but not in the HLA matched related donor transplantation (8). In order to observe the anti-tumor effect of this conditioning regimen in the aggressive T-cell lymphomas patients(including peripheral T-cell lymphoma and T lymphoblastoid cell lymphoma/leukemia, complete remission, partial remission, relapse after remission or refractory recurrent invasive patients), the investigators improved the drugs of conditioning regimen and increased the Thymoglobulin dose in the conditioning regimen for four days 10mg/kg total even in the HLA matched related donor transplantation. The purpose of this clinical trial is to reduce the incidence of GVHD at the same time does not increase the recurrence of the primary disease. The investigators expect that this ATG based conditioning regimen does play anti-tumor effect, reduce primary disease recurrence after transplantation, improve disease-free survival (DFS) and overall survival rate (OS) , as well as reduce the incidence and severity of GVHD, but the incidence of infection need to be observed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| highly aggressive T cell tumors | – | Drug: Rabbit Anti-human Thymocyte Globulin (ATG)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabbit Anti-human Thymocyte Globulin (ATG)Also: r-ATGThe 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) . | Drug | highly aggressive T cell tumors |
Primary outcome
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
6 secondary outcomes
Leukocyte engraftment
Time frame: 1 MONTH
Platelet engraftment
Time frame: 1 MONTH
Donor chimerism:
Time frame: 2 YEARS
Relapse incidence (RI)
Time frame: 2 YEARS
Overall survival rate
Time frame: 2 YEARS
Transplant related mortality(TRM)
Time frame: 2 YEARS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 11863096Rudiger 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.
- Background: PubMed 18626005Vose 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.
- Background: PubMed 17410187Mohty 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.
- Background: PubMed 23383989Du 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.
- Background: PubMed 19167677Grullich 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.
- Background: PubMed 14585365Meijer 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.
- Background: PubMed 7581076Przepiorka 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.
- Results publication: PubMed 22677206Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
liu guohua, doctor study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yang jun, master (18001890183, yangjuan74@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free surviva(PFS) rate at 2 years (time frame: 2 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290132, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.