Transplants: Clinical Trials Open for Enrollment
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Eligibility
- Male or female, Age 1 month – 75 years
- HCT recipients (Auto or Allograft)
- SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I)
- Unresponsive to standard defibrotide therapy as defined by at least one of the following:
- Patients with SOS/VOD failing to obtain a complete response (CR) defined by Grade I or less by Cairo/Cooke Grading criteria (1) (Appendix I). This would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day).
- Progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by Cairo/Cooke Grading criteria (1) (Appendix I) following at least 7 days of defibrotide (25mg/kg/day).
- Exclusion Criteria
- Patients who did not receive HCT
- Concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of CVVH)
- Active bleeding and/or hemorrhage of at least grade 2 and above
- History of development of Grade III/IV anaphylaxis probably or directly secondary to defibrotide
- Female patients who are pregnant or breast feeding
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05987124
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Male and female participants at least 12 years of age who have had allogeneic HCT.
- Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
- Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
- Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
- Have persistent cGVHD manifestations and systemic therapy is indicated.
- Karnofsky (if aged ≥16 years) / Lansky (if aged <16 years) Performance Score of ≥60.
- At least 12 years of age; weight ≥ 40 kilograms (kg).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN.
- Exclusion Criteria
- Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted).
- Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
- Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment.
- History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease).
- Corrected QT interval using Fridericia’s formula (QTc[F]) > 480 ms.
- Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05567406
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening