Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory Hairy Cell Leukemia
Status:
Terminated
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
BL22 is a type of protein that scientists have created to interact with certain cancer cells.
Experiments have shown that BL22 can bind with cancer cells that have a particular kind of
protein (called CD22 ) on their surface, and can kill those cells. CD22 is present on certain
types of hairy cell leukemia (HCL) cancer cells, and researchers have been working on
treatments that will use BL22 and other related proteins to interact with and kill these
kinds of cancer cells. The primary purpose of this study will be to provide access to and
treatment with BL22 for patients who have HCL in order to determine their response to the
treatment. In addition, the study will assess potential side effects of BL22 and examine why
some patients respond better than others to treatment with BL22 and related therapies.
This study will include about 21 to 25 adults who have been diagnosed with forms of HCL that
have not responded well to standard treatments such as surgery, chemotherapy, or radiation
therapy. These adults also will have received anti-CD22 therapies before, potentially
including treatments with BL22, and have not developed immunity or resistance to these
treatments.
Prior to the study, patients will undergo a 1- to 2-week screening period to assess their
eligibility for treatment. Eligible patients will participate in the study for up to 16
cycles of treatment, with each cycle lasting approximately 4 weeks. For each cycle, patients
will receive 1 prescribed dose of BL22 every other day for a total of 3 doses per cycle, and
will be assessed after every cycle to evaluate the success of the treatment. During the
evaluation visits, patients will be required to have a brief physical examination, give blood
and urine samples for testing, and undergo other tests as need to check heart and kidney
function and assess the state of the leukemia. Patients who agree will give additional blood,
urine, or bone marrow samples for future research purposes.