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HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis

NCT03456817 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-07-18

No results posted yet for this study

Summary

The purpose of this study is to find out whether compared to our standard low dose ATG with CSA, the high dose ATG with low-dose CSA minimizes the chances of relapse and chronic GVHD, without increasing the chances of other transplant complications.

Conditions

  • Graft-versus-host-disease
  • Relapse

Interventions

DRUG

Treatment Arm - high dose ATG

Patients agreeing to high dose ATG will be treated with 2 mg/kg daily on days -4 to 0. On days -4, -3 \& -2, ATG will be infused after fludarabine \& busulfan infusion. ATG will be infused over a minimum of 6 hrs on day -4 \& over at least 4 hrs on days -3, -2, -1 \& 0. Dose is based on actual body wt, \& rounded to nearest vial-Thymoglobulin is supplied in 25 mg vials, except if rounding would result in \>5% difference from calculated dose. Foothills Medical Center Unit 57 standard practice followed for ATG infusion. ATG premeds include methylprednisolone, diphenhydramine, and an antipyretic. Meperidine 25-50 mg IVPB every 4 hours will be given as needed for rigors. MTX is given 15 mg/m2 IV on day +1 \& 10 mg/m2 on days +3, +6 \& +11 posttransplant. First dose of methotrexate is given on day +1, at least 24 hrs following end of infusion of stem cell product.

DRUG

Control Arm - standard of care

The historical controls will have received and the concurrent controls will receive our standard GVHD prophylaxis, ie, ATG 4.5 mg/kg i.v. (0.5 mg/kg on day -2, 2.0 mg/kg on day -1 and 2.0 mg/kg on day 0), MTX (15 mg/m2 i.v. on day 1 and 10 mg/m2 i.v. on days 3, 6 and 11) and CSA (2.5 mg/kg twice a day i.v. starting from day -1, adjusting dose to target trough plasma CSA levels of 200-400 microg/L, switching to oral formulation before discharge from peritransplant hospitalization, targeting the trough plasma levels of 200-400 microg/L until day 56, and tapering to zero between day 56 and 84).

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Jan Storek, MD · Tom Baker Cancer Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03456817 on ClinicalTrials.gov