Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).

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

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Antilymphocyte Serum; Fludarabine; Melphalan; Thymoglobulin

Criteria

Inclusion Criteria:

1. Subject must have a confirmed diagnosis of one of the following:

1. Relapsed or refractory acute leukemia (myeloid or lymphoid)

2. Acute leukemia in first remission at high-risk for recurrence

3. Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis

4. Myelodysplastic syndromes

5. Chronic myeloproliferative disease

6. Recurrent, refractory or high-risk malignant lymphoma

7. Chronic lymphocytic leukemia, relapsed or with poor prognostic features

8. Multiple myeloma

9. Other hematological disorder in need of allogeneic transplant (e.g. blastoid dendritic cell neoplasm)

2. Age ≥ 18 years.

3. Likely to benefit from allogeneic transplant in the opinion of the transplant physician.

4. An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame.

5. Karnofsky Performance Status (KPS) of ≥ 70%.

6. Acceptable organ function as defined below:

1. Serum bilirubin: <2.0 mg/dL

2. ALT (SGPT) <3x upper limit of normal (ULN)

3. Creatinine Clearance: >50 mL/min/1.73m2 (eGFR as estimated by the modified MDRD equation)

4. Left ventricular ejection fraction >40%

5. Pulmonary diffusion capacity >40% predicted

7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Life expectancy is severely limited by concomitant illness or uncontrolled infection.

2. Evidence of chronic active hepatitis or cirrhosis

3. Uncontrolled HIV disease.

4. Pregnancy or lactation.

5. History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal perforation

6. History of allergic reactions attributed to compounds of similar chemical or biological composition as tocilizumab, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.