Hu-Mik-beta1 to Treat T-Cell Large Granular Lymphocytic Leukemia

Completed · Phase 1

Conditions studied: T-Cell Large Granular Lymphocytic Leukemia, Leukemia, T-Cell Large Granular Lymphocytic

In brief

This study will examine the use of the humanized Mik-beta-1 (Hu-Mik-beta1) antibody in patients with T-cell large granular lymphocytic leukemia (T-LGL). Patients with T-LGL often have reduced white blood cells, red blood cells, and platelets, and increased numbers of abnormal cells called large granular lymphocytes (LGLs). Patients may have recurrent infections, anemia, or abnormal bleeding. Hu-Mik-beta1 attaches to LGL cells and blocks the action of growth factors called interleukins that stimulate LGL growth. Blocking these interleukins may stop T-LGL leukemia cells from growing. This study will determine the dose and frequency of treatment with Hu-Mik-(SqrRoot) 1 that can safely be given to patients to coat the surface of their leukemic cells with antibody, determine how long the antibody lasts in the blood after injection, and examine the side effects and possible benefits of the drug in these patients. Patients age 18 or older with T-LGL may be eligible for this study. Candidates will be screened with a medical history and physical examination, review of pathology studies, skin biopsy, evaluation of rheumatoid arthritis if present, chest x-ray, computerized tomography (CT) scans and other imaging studies as needed, bone marrow biopsy, and blood and urine tests. Participants will receive a single dose of Hu-Mik-beta1 by a 90-minute infusion through a vein. Groups of patients will be treated with increasing doses (0.5, 1.0, and 1.5 mg/kg) of the antibody. Patients who develop serious drug side effects are taken off the study. The treatment requires a 3- to 4-day hospital stay. In addition to Hu-Mik-(SqrRoot) 1 treatment, patients will undergo the following tests and procedures: * Collection of blood for 8 days following the dose of Hu-Mik-beta1 to measure blood levels of the antibody. * Follow-up visits of 1 to 2 days at 22, 29, and 43 days after the dose of the antibody and then every 3 months for a total of 9 months. * Bone marrow aspirate and biopsy if one has not been done within 6 weeks before entering the study, and a repeat biopsy if complete remission of T-LGL is achieved after completing treatment. For the biopsy, an area of the hip is numbed and a special needle is used to draw bone marrow from the hipbone. * Imaging studies, such as chest x-ray and CT scan of the body after completing treatment if the screening scans showed abnormalities due to the T-LGL leukemia. * Lymph node biopsy in individuals with enlarged superficial lymph nodes due to T-LGL leukemia to see if the treatment is reaching the leukemia in the lymph nodes. There may or may not be a direct benefit from participating in this study. However, the results may help in the treatment of future patients.

Key facts

Study ID: NCT00076180
Run by: National Cancer Institute (NCI)
People needed: 9
Starts: 2004-03-01
Expected to finish: 2019-01-09
Last updated by the study team: 2019-01-11

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients must have none of the following at the time of enrollment:
Symptomatic central nervous system (CNS) involvement with LGL leukemia.
Pregnant or actively nursing patients are ineligible. The effects of Hu-MiK-Beta-1 on the developing fetus and nursing infant are unknown. Female patients of childbearing potential will be tested for pregnancy within 72 hours of initiating the study.
Patients with CTC grade 4 granulocytopenia or anemia.
Patients requiring platelet transfusions in the preceding 12-months for platelet counts of less than or equal to 10,000/mm(3) or spontaneous bleeding episodes.
Patients testing positive for the human immunodeficiency virus (HIV) or human T cell lymphotrophic virus (HTLV-I/II) are ineligible, because the toxicity may be different in this population.
Patients testing positive for hepatitis B virus surface antigen (HbsAg) or antibodies to hepatitis C virus are ineligible because Hu-MiK-Beta-1 therapy might be associated with increased viral replication.
Patients receiving prior therapy with murine MiK-Beta-1 that have developed human anti-mouse (HAMA) or human anti-human (HAHA) antibodies, or that have experienced CTC grade III or greater toxicity attributable to the antibody are ineligible.
Patients with a prior history of a Grade III or greater allergic reaction related to a previously administered humanized monoclonal antibody are ineligible.
Patients with other serious concurrent medical conditions (e.g., acute myocardial infarction within 6 months, unstable angina, NYHA Class II/IV congestive heart failure, respiratory insufficiency requiring oxygen therapy, uncontrolled hypertension, symptomatic cerebrovascular disease or stroke within 6 months, receiving immunosuppression for an organ graft, etc.) that may otherwise limit their survival are not eligible.
Other malignancy within five years, unless the probability of recurrence of the prior malignancy is less than or equal to 10 percent at 5-years. Patient's curatively treated for squamous cell carcinoma and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
Patients with serious active infection requiring systemic anti-infective therapy.
Any physical or psychological condition that would preclude drug administration or patient compliance with the protocol or that in the opinion of the investigator may pose an additional risk in administering the study drug to the patient or that would not permit the patient to complete the study or give Informed Consent.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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