Hematologic Malignancy Clinical Trial
Official title:
A Prospective Study of Tocilizumab for the Prevention of Graft Failure and Graft-versus-Host Disease in Haplo-Cord Transplantation
Verified date | September 2023 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 21 |
Est. completion date | May 2027 |
Est. primary completion date | September 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment | This is defined as:
Achieve an absolute neutrophil count (ANC) of 500 cells/microL for three consecutive days with the first on or prior to Day +21 post-transplant, AND Absence of a second nadir - a drop in the ANC to <300 cells/microL for five consecutive days - after initial neutrophil recovery. |
21 days post-transplant | |
Secondary | Progression-Free Survival | Time elapsed between Day 0 and progression of the underlying malignancy for which the transplant was performed, assessed up to 5 years post-transplant. | 5 years post-transplant | |
Secondary | Overall Survival | Time elapsed between Day 0 and death from any cause, assessed up to 5 years post-transplant. | 5 years post-transplant | |
Secondary | Transplant-Related Mortality | Proportion of deaths which cannot be explained by persistence, relapse or progression of the underlying malignancy once the preparative regimen starts, assessed up to 5 years post-transplant. | 5 years post-transplant | |
Secondary | Proportion of Platelet Engraftment Success | Proportion of patients who successfully achieve platelet engraftment, defined as a platelet count of >20k/microL for three consecutive days without transfusion support for seven consecutive days. | 6 months post-transplant | |
Secondary | Proportion of Failure of the Haplo-Graft | Proportion of patients with a failed haplo-graft, defined as the absence of neutrophil engraftment by Day +21 or a drop in the absolute neutrophil count to <0.3 cells/microL for five consecutive days occurring after initial neutrophil engraftment within the first 3 weeks post-transplantation (second nadir) | 21 days post-transplant | |
Secondary | Proportion of Acute Graft-versus-Host Disease | Proportion of patients who develop acute graft-versus-host disease | 1 year post-transplant | |
Secondary | Proportion of Chronic Graft-versus-Host Disease | Proportion of patients who develop chronic graft-versus-host disease | 5 years post-transplant |
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