Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

Korábbi kezelés

• Disease progression to Ruxolitinib previously
• GvHD requiring systemic therapy.
• Active thrombotic active microangiopathy requiring therapy.
• Pregnancy (positive Beta HCG test in a woman with childbearing potential defined as not postmenopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• Exposure to other investigational drugs within 4 weeks before enrollment.

Más betegség

• Progressive disease or any other systemic therapy post-SCT (radiation allowed)
• Active uncontrolled infections.
• History of veno-occlusive disorder post-transplant
• History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.
• Uncontrolled Hepatitis B/C, HIV, tuberculosis, mycobacterium, or fungal infection.
• Myocardial infarction or stroke within 1 year of study entry.

Laborértékek

• Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.

Egyéb

• Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (<2) in first complete remission.
• Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.
• Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.

• Adult patients with T-cell lymphoma [PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• Adequate hematologic function defined by absolute neutrophil count (ANC) > 1000/mm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets > 50K/mm3 without transfusion for at least 3 days and hemoglobin (Hb) > 8.0 g/dL without transfusion for at least 3 days.
• Adequate organ function defined by total Bilirubin < 1.5 x ULN, alanine aminotransferase (ALT) </= 3 x ULN, CKD-EPI eGFR ≥ 30 ml/min, SpO2 > 92% without supplemental oxygen.
• Chimerism testing within 30 days of screening that shows >90% CD3 and >90% CD33 (for allo-SCT only).[
• Able to tolerate oral or enteral medications.
• Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
• Able to read and sign informed consent.