Study on CPI-613 for Patients with Difficult or Returning Burkitt Lymphoma/Leukemia or High-Risk B-Cell Lymphoma

Inclusion Criteria

• Must be 12 years or older.
• Diagnosed with Burkitt Lymphoma/Leukemia or high-grade B-cell lymphoma with specific genetic changes.
• Have not responded to at least one previous treatment.
• Have not benefited from a bone marrow transplant or are not eligible for one.
• Have a performance status score of 3 or less, indicating some ability to carry out daily activities.
• Have measurable disease or bone marrow involvement.
• Must have recovered from any side effects of previous cancer treatments.
• Must have or be willing to have a central venous access device for treatment.
• Must have adequate liver, kidney, and blood clotting function based on recent lab tests.
• Women who can become pregnant must use effective birth control and have a negative pregnancy test before starting treatment.
• Women must agree not to breastfeed during the study.
• Men must use effective birth control unless they are infertile.

Exclusion Criteria

• Have received chemotherapy with stem cell support in the last 2 months.
• Have a medical condition that is not stable despite treatment.
• Have very low platelet counts unless due to bone marrow involvement.
• Have serious heart or lung disease that could increase the risk of side effects.
• Have active disease in the brain or spinal cord, unless certain conditions are met.
• Have uncontrolled bleeding or a bleeding disorder.
• Have any condition that the study doctor thinks could compromise safety.
• Have uncontrolled HIV infection or certain HIV-related conditions.
• Have received other cancer treatments or investigational drugs within the last 2 weeks, except for certain types of radiation.
• Have a psychiatric or social condition that could affect participation in the study.
• Have had a stem cell transplant in the last 2 months or have active graft-versus-host disease.