Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma

This is an interventional treatment trial for Hodgkin Lymphoma Read More

Inclusion Criteria:

• 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.
• If a hematopoietic cell transplant was refused, or the patient was not eligible to receive a transplant, the patient is still eligible to participate in the trial if the patient has received two or more prior chemotherapy based regimens.
• 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.

Exclusion Criteria:

• 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 with active infection are not eligible. This includes patients requiring anti-infective treatment during the 4 week period prior to enrollment. Patients on prophylactic anti-infective agents will be eligible provided they have no signs of active infection.
• 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.