Hematologic Malignancy Clinical Trial
Official title:
A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies
NCT number | NCT05579769 |
Other study ID # | CNI60 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 4, 2022 |
Est. completion date | April 2027 |
The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant. Primary Objectives To estimate the incidence of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calcineurin inhibitors after day +60 post first allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor HCT for hematological malignancies. Secondary objective Determine the cumulative incidence of relapse, NRM, chronic GVHD, and OS in study participants at one year post-transplant. Exploratory objectives - To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) profiles of ruxolitinib, fludarabine, and rATG. - To assess immune reconstitution in study participants within the first year post-HCT.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | April 2027 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion criteria Diagnosis: - Patients with high risk acute lymphoblastic leukemia in first remission. Examples include, but are not limited to, patients with certain leukemic cell cytogenetic findings (e.g. t(9;22) or t(4;11)); delayed response to induction chemotherapy; re-emergence of leukemic blasts by MRD (at any level) in patients previously MRD negative; persistently detectable MRD at lower levels; early T-cell precursor (ETP) ALL. - Patients with acute lymphoblastic leukemia beyond first remission. - Patients with Hodgkin's disease beyond first remission or with refractory disease. - Patients with chronic myelogenous leukemia. - Patients with primary or secondary myelodysplastic syndrome. - Patients with Non-Hodgkin's lymphoma beyond first remission or with refractory disease. - Patients with de novo acute myeloid leukemia in or beyond first remission or with relapsed or refractory disease, or myeloid sarcoma (extra-medullary AML). - Patients with secondary acute myeloid leukemia. - NK cell lymphoblastic leukemia in any CR. - Biphenotypic, bilineage, or undifferentiated leukemia. - Juvenile Myelomonocytic Leukemia (JMML) - All patients with prior evidence of CNS leukemia must be treated and be in CNS CR. Patients must have a related or unrelated donor matched at 12 of 12 HLA alleles. Patient must have a Karnofsky/Lansky score of 70 or higher. Patients must be 12 years of age or older. Patients must have a shortening fraction >26% or left ventricular ejection fraction >40%. Patients must have bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal. Patients must have creatinine clearance, or a glomerular filtration rate (GFR), greater than 70 mL/min/1.73m2. Patients must be free of severe infection that upon determination of principal investigator precludes BMT. Patients must have FVC >50% predicted OR, if unable to perform pulmonary function testing, must maintain pulse oximetry oxygen saturation >92% on room air. Female patients of childbearing age must have a negative pregnancy test. Exclusion criteria - Patients who have undergone prior HCT. - Patients who have a peripheral blood stem cell graft source. - Patients who have a non-permissive mismatch at the DPB1 allele. - Patients who are HIV positive. - Patients positive for Hepatitis B surface antigen (HBsAg). - Patients positive for Hepatitis C. - Patients with latent tuberculosis with positive TB IFN gamma release assay. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calcineurin inhibitors after day 100 post first allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor HCT for hematological malignancies. | Development of saGVHD at or before Day 100 post transplant is considered as an event. | 100 days post transplant | |
Secondary | Incidence of Leukemic Relapse | Bone marrow studies for disease status evaluation will be performed. | One-year post-transplantation. | |
Secondary | Non-relapse mortality | The one-year non-relapse mortality (NRM is defined by the patient who expire while in remission within one year. The probability of NRM is estimated by the cumulative incidence method. | One-year post-transplantation | |
Secondary | Overall Survival | The one-year survival is defined by the patient who has not died within one year after post transplantation. The probability is estimated by the Kaplan-Meier method. | one year post-transplantation | |
Secondary | Incidence of Chronic Graft Versus Host Disease (cGVHD) | Ongoing assessment of toxicity will be done using the NCI CTCAE version 3.0. Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The cumulative incidence of cGvHD will be estimated using Kalbfleisch-Prentice method. | 1 year post transplant |
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