NCT02290132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

3.3 years

First QC Date

October 13, 2014

Last Update Submit

November 8, 2014

Conditions

Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

Keywords

acute lymphoblastic leukemialymphoblastic lymphomastem-cell transplantT-cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

    2 YEARS

Secondary Outcomes (6)

  • Leukocyte engraftment

    1 MONTH

  • Platelet engraftment

    1 MONTH

  • Donor chimerism:

    2 YEARS

  • Relapse incidence (RI)

    2 YEARS

  • Overall survival rate

    2 YEARS

  • +1 more secondary outcomes

Study Arms (1)

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)

Interventions

Rabbit Anti-human Thymocyte Globulin (ATG)DRUG

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) .

Also known as: r-ATG
highly aggressive T cell tumors

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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
  • 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.

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. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai First People's HOSPITAL

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (8)

  • 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: 11863096BACKGROUND

  • Vose 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: 18626005BACKGROUND

  • Mohty 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: 17410187BACKGROUND

  • Du 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: 23383989BACKGROUND

  • Grullich 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: 19167677BACKGROUND

  • Meijer 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: 14585365BACKGROUND

  • Przepiorka 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: 7581076BACKGROUND

  • Liu 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: 22677206RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell

Interventions

thymoglobulin

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma

Study Officials

  • liu guohua, doctor

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

yang jun, master

CONTACT

18001890183yangjuan74@hotmail.com

wang chun, doctor

CONTACT

13386259777wangchun2@medmail.com.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
4 Years
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 13, 2014

First Posted

November 13, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

CN(1)