| Eligibility |
Inclusion Criteria:
- Women and men with histologically or cytologically confirmed Hodgkin and all NHL
subtypes excluding Burkitt, CLL and lymphoblastic lymphoma that is considered to have
relapsed or to be refractory to primary chemotherapy.
- No previous anti-cancer therapy for at least 21 days and recovered from all treatment
related toxicity
- Prior radiation is allowed prior to study start (1st dose of study medication) if at
least 21 days have elapsed since prior large-field radiation therapy and all treatment
related toxicity has resolved. At least 3 months must have passed since
radio-immunotherapy.
- Prior auto graft is allowed prior to study start (1st dose of study medication), but
patients must be at least 3 months from date of stem cell infusion and have recovered
to = grade 1 toxicities related to this procedure.
- Prior allogeneic transplants is allowed prior to study start (1st dose of study
medication), but patients must be at least 6 months from date of stem cell infusion,
have no evidence of GVHD, be off all immunosuppressant medications, and have recovered
to = grade 1 toxicities related to this procedure.
- Age >18 years
- ECOG (Eastern Cooperative Oncology Group) Performance status =2
- Life expectancy without treatment > 12 weeks
- Patients must have adequate hematologic, hepatic, and renal function as defined as:
Absolute neutrophil count =1,000/µl, Platelets =75,000/µl, (50,000/ µl if due to BM
involvement), Direct bilirubin< 1.5 mg/dl, unless due to Gilbert's or secondary to
hemolysis, AST (Aspartate Aminotransferase) and/or ALT (Alanine Transaminase) <2.5 X
institutional upper limit of normal unless due to lymphomatous involvement of the
liver, Creatinine < 1.5 mg/dl and/or creatinine clearance >60 mL/min using the
Cockcroft-Gault formula and no symptoms attributable to grade 2 or higher peripheral
neuropathy.
- Should a woman become pregnant or suspect that she is pregnant while she or her
partner is participating in this study, she should inform the treating physician
immediately.
- Subjects must have the ability to understand and the willingness to sign a written
informed consent document.
Exclusion Criteria:
- Patients who are currently receiving any other experimental agent, patients must have
stopped other experimental agents at least 21 days prior to 1st study dose.
- Any prior to exposure to Jakafi
- Patients with untreated brain metastases are excluded from this clinical trial because
of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Jakafi or Velcade.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because Jakafi is
inhibitor of the Jak-1 and Jak-2 kinases with the potential for teratogenic or
abortifacient effects. Because there is an unknown, but potential risk for adverse
events in nursing infants secondary to treatment of the mother with Jakafi,
breastfeeding should be discontinued if the mother is treated with Jakafi. These
potential risks may also apply to other agents used in this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with Jakafi. In addition, these
patients are at increased risk of lethal infections when treated with marrow
suppressive therapy. Appropriate studies will be undertaken in patients receiving
combination antiretroviral therapy when indicated.
- Patients with grade 2 or higher peripheral neuropathy are excluded.
- Patients with CLL (Chronic Lymphocytic Leukemia), Burkitt or lymphoblastic lymphoma
are excluded.
- Patients who would be required to concurrently take ruxolitinib in conjunction with a
strong CYP3A4 inhibitors and have a platelet count less than 100,000 are ineligible
for the study.
- Patient who are required to take a strong CYP3A4 inducer are excluded from the study.
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