Status:
ACTIVE_NOT_RECRUITING
Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Hematologic Malignancy
Bone Marrow Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 tocil...
Detailed Description
This study is a prospective phase II non-inferiority study investigating tocilizumab as a potential alternative to anti-thymocyte globulin (ATG) in haplo-cord transplantation. It is a single-center st...
Eligibility Criteria
Inclusion
- Subject must have a confirmed diagnosis of one of the following:
- Relapsed or refractory acute leukemia (myeloid or lymphoid)
- Acute leukemia in first remission at high-risk for recurrence
- Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis
- Myelodysplastic syndromes
- Chronic myeloproliferative disease
- Recurrent, refractory or high-risk malignant lymphoma
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- Multiple myeloma
- Other hematological disorder in need of allogeneic transplant (e.g. blastoid dendritic cell neoplasm)
- Age ≥ 18 years.
- Likely to benefit from allogeneic transplant in the opinion of the transplant physician.
- An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame.
- Karnofsky Performance Status (KPS) of ≥ 70%.
- Acceptable organ function as defined below:
- Serum bilirubin: \<2.0 mg/dL
- ALT (SGPT) \<3x upper limit of normal (ULN)
- Creatinine Clearance: \>50 mL/min/1.73m2 (eGFR as estimated by the modified MDRD equation)
- Left ventricular ejection fraction \>40%
- Pulmonary diffusion capacity \>40% predicted
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Life expectancy is severely limited by concomitant illness or uncontrolled infection.
- Evidence of chronic active hepatitis or cirrhosis
- Uncontrolled HIV disease.
- Pregnancy or lactation.
- History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal perforation
- 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.
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04395222
Start Date
October 7 2020
End Date
June 1 2027
Last Update
January 6 2026
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065