Clinical trial · Interventional
Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator left institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Myeloid Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-thymocyte globulin (ATG) | Drug | — | UNRESOLVED |
| Bone marrow infusion | Drug | Bone Marrow Transplantation | ALIAS |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporine | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplant Patients
- interventionNames
- Drug: Ruxolitinib
- Drug: Mesna
- Drug: Anti-thymocyte globulin (ATG)
- Drug: Cyclosporine
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Methotrexate
- Radiation: Total Body Irradiation (radiation treatment)
- Drug: Bone marrow infusion
- Drug: Busulfan
- Drug: Thiotepa
Primary outcomes (1)
- measure
- Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies.
- timeFrame
- 100 days post transplant
- description
- Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available