Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Xencor, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosed with HL or ALCL.
Patients must have received two or more prior therapeutic regimens, one of which should include hematopoietic cell transplant, either autologous or allogeneic transplant.
You may not be if
Patients who have received allogeneic transplant must not have relapsed less than 6 months after their transplant and they must be at least 200 days post-transplant prior to enrollment, and with no evidence of GVHD
Patients should have at least one radiographically measurable site of disease of 1.5 cm in the largest dimension.
Patients must have completed all anti-cancer treatment \> 4 weeks prior to enrollment.
Patients must have completed any palliative corticosteroid therapy (e.g. for management of Type B symptoms) \> 2 weeks prior to enrollment.
Patients must be 18 years of age.
Required baseline laboratory data:
* Platelet count 80,000/mm3 (patients must not be platelet transfusion-dependent as evidenced by maintenance of platelet count above 50,000/mm3 in the 28 days prior to enrollment without transfusion)
* Absolute neutrophil count \> 1,500/mm3
* Creatinine ≤ 1.5 times ULN
* ALT (SGPT) /AST (SGOT) ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Patients with known HL or ALCL involvement of either the leptomeningeal or central nervous system.
Patients requiring treatment with oral or intravenous corticosteroids or other oral or intravenous immunosuppressive agents.
Patients that have been designated Class III or IV by the New York Heart Association criteria.
Patients with a history of myocardial infarction or stroke within the last 6 months.
Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
Patients with a history of prior malignancy other than HL or ALCL that have not been in remission for greater than 5 years, with the exception of basal or squamous skin carcinoma, cervical carcinoma in situ on biopsy, or localized prostate cancer (Gleason score \< 5).
Patients who are pregnant or breastfeeding.
Patients with major surgery or radiation therapy within four weeks prior to enrollment.