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Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

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ClinicalTrials.gov Identifier: NCT02677181
Recruitment Status : Unknown
Verified February 2016 by Daihong Liu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Collaborators:
309th Hospital of Chinese People's Liberation Army
Beijing Naval General Hospital
Space Center Hospital, Peking University
Information provided by (Responsible Party):
Daihong Liu, Chinese PLA General Hospital

Brief Summary:
The purpose of this study is to determine the efficacy and safety of combined ATG (antithymocyte globulin ) regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).

Condition or disease Intervention/treatment Phase
aGVHD Drug: ATG Drug: CsA Drug: mycophenolate mofetil Drug: Methotrexate Phase 4

Detailed Description:
Transplantation with G-CSF (Granulocyte colony stimulating factor )mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long-term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Study of Combined ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: ATG combined regimen

ATG combined regimen for prophylaxis of GVHD, includes ATG, MMF(Mycophenolate mofetil ),CsA (cyclosporin A) and MTX (methotrexate).

All recipients in this arm received ATG, CsA, mycophenolate mofetil, and short-term methotrexate for GVHD prophylaxis. ATG (Thymoglobuline, rabbit) was used on 2.5 mg/kg/d from days -4 to -3). CsA (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered. From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30. After graft infusion, MTX was given for all patients at 15 mg/m2 on day +1 and 10 mg/m2 on days +3, +6 and +11.

Drug: ATG
rabbit ATG(Sanofi)
Other Name: Thymoglobuline

Drug: CsA
cyclosporine (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered.
Other Name: Neoral/Sandimmun

Drug: mycophenolate mofetil
From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.
Other Name: MMF(Novartis)

Drug: Methotrexate
short-term methotrexate
Other Name: MTX(Pfizer)

Active Comparator: no-ATG
regimen for prophylaxis of GVHD without ATG. The regimen includes MMF,CsA and MTX.CsA (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered. From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30. After graft infusion, MTX was given for all patients at 15 mg/m2 on day +1 and 10 mg/m2 on days +3, +6 and +11.
Drug: CsA
cyclosporine (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered.
Other Name: Neoral/Sandimmun

Drug: mycophenolate mofetil
From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.
Other Name: MMF(Novartis)

Drug: Methotrexate
short-term methotrexate
Other Name: MTX(Pfizer)




Primary Outcome Measures :
  1. Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) [ Time Frame: three months ]
    Acute graft versus host disease grading criteria (refer to Glucksberg criteria)


Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: two years ]
  2. Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria [ Time Frame: two years ]
  3. DFS(disease-free survival ) [ Time Frame: two years ]
    disease-free survival

  4. TRM(treatment-related mortality ) [ Time Frame: two years ]
    treatment-related mortality

  5. Number of participants with cGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) [ Time Frame: two years ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. acute myeloid leukemia (AML) in CR1 (complete remission 1) or CR2 (complete remission 2) phase regardless of cytogenetics;
  2. CML CP(chronic myelogenous leukemia , chronic phase);
  3. MDS-RAEB(myelodysplastic syndrome -refractory anemia with excess blasts ).
  4. All patients should aged 40 to 70 years
  5. Have matched sibling donor.
  6. Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases .

Exclusion Criteria:

  1. Patients aged less than 40 years old ;
  2. Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases;
  3. AML patients with t (15;17);

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): NCT02677181


Contacts
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Contact: Daihong Liu, Doctor 86-13681171597 daihongrm@163.com
Contact: Liping Dou, Doctor 86-13681207138 lipingruirui@163.com

Locations
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China, Beijing
Liping Dou Recruiting
Beijing, Beijing, China, 100853
Contact: Daihong Liu, doctor    86-13681171597    daihongrm@163.com   
Contact: Liping Dou, doctor    86-13681207138    lipingruirui@163.com   
Principal Investigator: Daihong Liu, doctor         
Sponsors and Collaborators
Chinese PLA General Hospital
309th Hospital of Chinese People's Liberation Army
Beijing Naval General Hospital
Space Center Hospital, Peking University
Investigators
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Study Director: Daihong Liu, Doctor Chinese PLA General Hospital

Publications:
Armand P, Kim HT, Zhang MJ, Perez WS, Dal Cin PS, Klumpp TR, Waller EK, Litzow MR, Liesveld JL, Lazarus HM, Artz AS, Gupta V, Savani BN, McCarthy PL, Cahn JY, Schouten HC, Finke J, Ball ED, Aljurf MD, Cutler CS, Rowe JM, Antin JH, Isola LM, Di Bartolomeo P, Camitta BM, Miller AM, Cairo MS, Stockerl-Goldstein K, Sierra J, Savoie ML, Halter J, Stiff PJ, Nabhan C, Jakubowski AA, Bunjes DW, Petersdorf EW, Devine SM, Maziarz RT, Bornhauser M, Lewis VA, Marks DI, Bredeson CN, Soiffer RJ, Weisdorf DJ. Classifying cytogenetics in patients with acute myelogenous leukemia in complete remission undergoing allogeneic transplantation: a Center for International Blood and Marrow Transplant Research study. Biol Blood Marrow Transplant. 2012 Feb;18(2):280-8. doi: 10.1016/j.bbmt.2011.07.024. Epub 2011 Jul 31.

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Responsible Party: Daihong Liu, Head of Hematology departemnt in Chinese PLA General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02677181     History of Changes
Other Study ID Numbers: 81370666
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daihong Liu, Chinese PLA General Hospital:
ATG
Matched sibling donor
peripheral blood stem cell transplantation
Additional relevant MeSH terms:
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Mycophenolic Acid
Methotrexate
Thymoglobulin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents