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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Treatments: Acetaminophen; Antilymphocyte Serum; Cyclosporine; Cyclosporins; Diphenhydramine; Methotrexate; Methylprednisolone; Thymoglobulin

Criteria

Inclusion Criteria:

• Inclusions:

1. First allogeneic HCT, performed for a hematologic malignancy, using filgrastim-mobilized peripheral blood stem cells (PBSC).

2. Conditioning with fludarabine 50 mg/m2 daily on day -6 to -2, busulfan approximately 3.2 mg/kg daily on day -5 to -2 with PK adjustment (target AUC of 3750 uM*min/L) and total body irradiation (TBI) 2 Gy daily on day -1 and 0 (before graft infusion), ie, our standard myeloablative conditioning.72

3. Planned GVHD prophylaxis with our standard of low-dose ATG (4.5 mg/kg) + MTX + high-dose CSA.

4. HLA matched sibling donor, or ≥7/8 HLA allele-matched unrelated donor.

5. Age >17 years.

Exclusion Criteria:

1. Nonmyeloablative conditioning.

2. Cord blood or marrow graft.

3. Previous autologous or allogeneic HCT.

4. Bilirubin >1.5-fold above upper normal limit (UNL), ALT or AST >2.0-fold above UNL, or alkaline phosphatase >2.5-fold above UNL.

5. HIV positive by a serologic test that includes detection of both antibody and antigen)

6. Increased risk of tuberculosis, defined as patient requiring an anti-tuberculosis drug peritransplant. All patients with a history of tuberculosis (active or latent) or contact with a person with active tuberculosis will be evaluated by an infectious disease specialist to determine whether treatment or prophylaxis of tuberculosis with an anti-tuberculosis drug peritransplant is needed. The infectious disease specialist will order tests (eg, Mantoux tuberculin skin test or interferon gamma release test) as needed to arrive at the decision on whether an anti-tuberculosis drug peritransplant is needed.

7. High risk of cytomegalovirus (CMV) disease or recurrent CMViremia based on donor negative AND recipient positive CMV serostatus

8. High risk of PTLD based on donor positive AND recipient negative Epstein-Barr virus (EBV) serostatus (EBNA1 or VCA IgG)

9. Hypersensitivity to rabbit blood protein, Thymoglobulin or a Thymoglobulin excipient.

10. Contraindication to methotrexate:

1. Hypersensitivity to methotrexate or to any ingredient in the formulation or component of the container.

2. Females of childbearing potential who are pregnant, breastfeeding or unwilling to use adequate contraception from the time of enrolment until at least day 100 posttransplant.