Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation

NCT04778618 | Unknown Phase 2 DMC

• 1 other identifier: S2020-484-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the response and toxicity rate of two different dosages (Individualized dosage VS. fixed dosage) of ATG as a prophylaxis for acute GVHD in haploidentical peripheral blood stem cell transplantation (haplo-PBSCT).

Conditions

Haploidentical Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

• The cumulative incidences of CMV reactivation

  The cumulative incidences of CMV reactivation in participants after transplantation, tested by realtime PCR

  180 days after transplantation

• The cumulative incidences of EBV reactivation

  The cumulative incidences of EBV reactivation in participants after transplantation, tested by realtime PCR

  180 days after transplantation

Secondary Outcomes (7)

• Engraftment

  28 days after transplantation

• The cumulative incidences of aGVHD (refer to MAGIC criteria)

  100 days after transplantation

• The cumulative incidences of cGVHD (refer to NIH criteria)

  2 years after transplantation

• Relapse

  1 years after transplantation

• Nonrelapse mortality (NRM)

  1 years after transplantation

Study Arms (1)

Individual dose of Thymoglobulin

EXPERIMENTAL

Individual dose of Thymoglobulin (r-ATG) : Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 6 mg/kg to 10mg/kg)

Drug: Antithymocyte Globulin

Interventions

Antithymocyte Globulin DRUG

Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 6 mg/kg to 10mg/kg). Antithymocyte globulin (ATG) was added to conditioning regimens for 4 days (days -5 and -2). Prophylaxis against graft-versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate

Individual dose of Thymoglobulin

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmed diagnosis of hematological malignancies refer to the 2016 WHO classification.
• Aged 14 to 60 years.
• Karnofsky or Lansky performance status \[27\] ≥ 70%. Please refer to Appendix A.
• First transplantation.
• Adequate organ function
• Patient and/or legal guardian must sign informed consent for HSCT.

You may not qualify if:

• Ex-vivo T-cell depleted grafts.
• Pregnancy or breast-feeding or unwilling to use proper contraception.
• Unable to assess whether the malignancy is in complete remission.
• History of hypersensitivity to any biological product.
• Sensibility to rabbit proteins or previous treatment with Thymoglobuline®.
• Subjects with uncontrollable systemic infection (viral, bacterial or fungal).
• Participation in other trial in which the dose of Thymoglobuline® is fixed other than individualized dose.
• Unable to sign the informed consent form.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (6)

• Call SK, Kasow KA, Barfield R, Madden R, Leung W, Horwitz E, Woodard P, Panetta JC, Baker S, Handgretinger R, Rodman J, Hale GA. Total and active rabbit antithymocyte globulin (rATG;Thymoglobulin) pharmacokinetics in pediatric patients undergoing unrelated donor bone marrow transplantation. Biol Blood Marrow Transplant. 2009 Feb;15(2):274-8. doi: 10.1016/j.bbmt.2008.11.027.

  PMID: 19167688 BACKGROUND

• Walker I, Panzarella T, Couban S, Couture F, Devins G, Elemary M, Gallagher G, Kerr H, Kuruvilla J, Lee SJ, Moore J, Nevill T, Popradi G, Roy J, Schultz KR, Szwajcer D, Toze C, Foley R; Canadian Blood and Marrow Transplant Group. Pretreatment with anti-thymocyte globulin versus no anti-thymocyte globulin in patients with haematological malignancies undergoing haemopoietic cell transplantation from unrelated donors: a randomised, controlled, open-label, phase 3, multicentre trial. Lancet Oncol. 2016 Feb;17(2):164-173. doi: 10.1016/S1470-2045(15)00462-3. Epub 2015 Dec 24.

  PMID: 26723083 BACKGROUND

• Bacigalupo A, Lamparelli T, Barisione G, Bruzzi P, Guidi S, Alessandrino PE, di Bartolomeo P, Oneto R, Bruno B, Sacchi N, van Lint MT, Bosi A; Gruppo Italiano Trapianti Midollo Osseo (GITMO). Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation. Biol Blood Marrow Transplant. 2006 May;12(5):560-5. doi: 10.1016/j.bbmt.2005.12.034.

  PMID: 16635791 BACKGROUND

• Bacigalupo A, Lamparelli T, Bruzzi P, Guidi S, Alessandrino PE, di Bartolomeo P, Oneto R, Bruno B, Barbanti M, Sacchi N, Van Lint MT, Bosi A. Antithymocyte globulin for graft-versus-host disease prophylaxis in transplants from unrelated donors: 2 randomized studies from Gruppo Italiano Trapianti Midollo Osseo (GITMO). Blood. 2001 Nov 15;98(10):2942-7. doi: 10.1182/blood.v98.10.2942.

  PMID: 11698275 BACKGROUND

• Remberger M, Svahn BM, Mattsson J, Ringden O. Dose study of thymoglobulin during conditioning for unrelated donor allogeneic stem-cell transplantation. Transplantation. 2004 Jul 15;78(1):122-7.

  PMID: 15257050 BACKGROUND

• Wang H, Wang N, Wang L, Du J, Li F, Shao Y, Peng B, Luan S, Wang L, Jin X, Gao C, Dou L, Liu D. Targeted dosing of anti-thymocyte globulin in adult unmanipulated haploidentical peripheral blood stem cell transplantation: A single-arm, phase 2 trial. Am J Hematol. 2023 Nov;98(11):1732-1741. doi: 10.1002/ajh.27068. Epub 2023 Sep 14.

  PMID: 37706580 DERIVED

MeSH Terms

Interventions

Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Dai-hong Liu, Dr.

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 3, 2021
• Study Start: December 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: January 14, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)