ACY-1215 for Relapsed/Refractory Lymphoid Malignancies

This is an interventional treatment trial for Lymphoma focused on measuring hematologic malignancies, hodgkin, hodgkins, non-hodgkin, non-hodgkins, mantle cell lymphoma, follicular, lymphoma, lymphoid malignancies Read More

Inclusion Criteria:

• Patients must have histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's lymphoma (World Health Organization criteria), for which they are unwilling or unable to undergo an autologous stem cell transplant. Patients may have relapsed after prior stem cell transplant.
• Must have received first line chemotherapy. No upper limit to number of prior therapies.
• Patients must have measurable disease.
• Patients must be age ≥ 18.
• Patient has a Karnofsky Performance Status score of ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
• The patient or the patient's legal representative is able to understand the risks of the study and provide signed informed consent and authorization to use protected health information (in accordance with national and local privacy regulations).

• Patient has adequate bone marrow reserve, as evidenced by:

  • Absolute neutrophil count (ANC) of ≥1.0x109/L.
  • Platelet count of ≥50x109/L.
• Patient has adequate renal function, as evidenced by a creatinine within the institutional limits of normal or a calculated creatinine clearance of ≥30 mL/min according to the Cockcroft-Gault equation.
• Patient has adequate hepatic function, as evidenced by serum bilirubin values <2.0 mg/dL and serum alanine transaminase (ALT) and/or aspartate transaminase (AST) values <3 × the upper limit of normal (ULN) of the local laboratory reference range. (Patients with isolated elevations in alkaline phosphatase (ALP) <5 × ULN in the presence of bony disease are not excluded from participating in the study.)
• Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of (C1D1) and have adequate contraception. (A female is considered to be not of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for 12 consecutive months.)

Exclusion Criteria:

• Prior Therapy

  1. Patients who have had chemotherapy or radiotherapy within 2 weeks of study drug treatment or those who have not recovered from adverse events due to agents administered
  2. Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone during the 7 days prior to the start of the study drugs.
  3. No monoclonal antibody within 3 months unless evidence of disease progression.
• Patients may not be receiving any other investigational agents.
• Patients with known central nervous system metastases, including lymphomatous meningitis

• Any known cardiac abnormalities such as:

  • Congenital long QT syndrome
  • Corrected QT (QTc) interval ≥ 500 milliseconds;
• Uncontrolled inter-current illness
• Pregnant or nursing women
• Patient is known to be Human Immunodeficiency Virus (HIV)-positive
• Active Hepatitis A, Hepatitis B, or Hepatitis C infection
• Patient has a history of surgery that would interfere with the administration or absorption of the oral study drugs