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Compares treatment options for Graft Vs Host Disease
Official title Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
ClinicalTrials.gov ID: NCT06008808
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, being studied as a potential treatment for graft vs host disease.
Also referred to as Jakafi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Allogeneic hematopoietic cell transplantation (HCT) is one of the only curative intent therapies available for hematologic malignancies. HLA-matched sibling donors have historically offered the best clinical results but are unavailable for the majority of patients, while most patients do have readily available haploidentical donors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet the following criteria within 30 days prior to Day -3 unless otherwise noted.
- Diagnosis of one of the hematological malignancies listed below:
- Acute myelogenous leukemia (AML) in complete morphological remission, complete remission with incomplete hematologic recovery, and complete remission...
- Acute lymphocytic leukemia (ALL) in complete morphological remission (MRD negative by flow cytometry with sensitivity to ≤ 10-4).
- Myelodysplastic syndrome with ≤ 10% blasts in bone marrow.
You likely can't join if
- Prior allogeneic transplant (regardless of whether donor was related, unrelated, or cord). Prior autologous transplant is not exclusionary.
- Presence of donor specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of ≥ 4000 as assessed by the single antigen bead assay.
- Known HIV or active hepatitis B or C infection. Known current history of active tuberculosis.
- Known hypersensitivity to one or more of the study agents.
- Planning to receive antithymocyte globulin as part of the pre-transplant conditioning regimen.
- Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (Day -3).
See the full eligibility criteria
- Patients must meet the following criteria within 30 days prior to Day -3 unless otherwise noted.
- Diagnosis of one of the hematological malignancies listed below:
- Acute myelogenous leukemia (AML) in complete morphological remission, complete remission with incomplete hematologic recovery, and complete remission with partial hematologic recovery (based on ELN Criteria47).
- Acute lymphocytic leukemia (ALL) in complete morphological remission (MRD negative by flow cytometry with sensitivity to ≤ 10-4).
- Myelodysplastic syndrome with ≤ 10% blasts in bone marrow.
- Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HD) in second or greater complete or partial remission.
- Myelofibrosis with ≤ 10% blasts in bone marrow. Up to five patients with myelofibrosis will be permitted in Regimen 1 and up to five in Regimen 2.
- AML in partial response. One patient will be enrolled in Regimen 1 given the prospect of potential benefit.
- Planned treatment is T cell-replete peripheral blood haploidentical donor transplantation.
- Available HLA-haploidentical donor who meets the following criteria:
- Blood-related family member, including (but not limited to) sibling, offspring, cousin, nephew, or parent. Younger donors should be prioritized.
- At least 18 years of age.
- HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards.
- In the investigator's opinion, is in general good health and medically able to tolerate leukapheresis required for harvesting hematopoietic stem cells.
- No active hepatitis.
- Negative for HTLV and HIV.
- Not pregnant.
- Donor selection will be in compliance with FDA guidelines as provided in 21 CFR 1271 for donor eligibility...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate organ function as defined below:
- Total bilirubin ≤ 1.5 x IULN.
- AST (SGOT) and ALT (SGPT) ≤ 3.0 x IULN.
- Creatinine ≤ 1.5 x IULN OR creatinine clearance ≥ 45 mL/min/1.73 m2 by Cockcroft-Gault Formula.
- Oxygen saturation ≥ 90% on room air.
- LVEF ≥ 40%.
- FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted. If DLCO is \< 40%, patients will still be considered eligible if deemed safe after a pulmonary evaluation.
- Able to receive GVHD prophylaxis with tacrolimus, mycophenolate mofetil (if applicable), and cyclophosphamide.
- At least 18 years of age at the time of study consent
- The effects of ruxolitinib and abatacept on the developing human fetus are unknown. Additionally, tacrolimus may increase risk of hypertension, preeclampsia, preterm birth, and low birth weight; and mycophenolate...
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Prior allogeneic transplant (regardless of whether donor was related, unrelated, or cord). Prior autologous transplant is not exclusionary.
- Presence of donor specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of ≥ 4000 as assessed by the single antigen bead assay.
- Known HIV or active hepatitis B or C infection. Known current history of active tuberculosis.
- Known hypersensitivity to one or more of the study agents.
- Planning to receive antithymocyte globulin as part of the pre-transplant conditioning regimen.
- Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (Day -3).
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of Day -3.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmias.
- Immunosuppressive doses of steroids. people with steroids for adrenal insufficiency will not be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.