CompletedPhase 1

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

United States9 participantsStarted 2004-03-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA All patients must have histologically or cytologically confirmed T-LGL leukemia as defined by: i. A peripheral blood smear or bone marrow biopsy/aspirate with morphological findings consistent with LGL as determined by Hematopathology section, the NIH Clinical Center, or the Laboratory of Pathology, NCI, and; ii. An absolute C3+, CD8+, usually CD57+ cell (T-LGL) count greater than or equal to 1000/uL in the peripheral blood or bone marrow as measured by flow cytometry. iii. At least 50% of the CD3+/CD8+ cells must also express CD122 (IL-2/15RB plus). iv. Clonal T cell receptor (TcR) rearrangement while desirable, is not a requirement for eligibility. TcR rearrangement may be determined by Southern blotting or polymerase chain reaction (PCR). Patients must have T-LGL-associated hemocytopenia(s)\* as defined by an absolute granulocyte count (AGC) less than 1000/uL, platelet count less than100,000/uL or hemoglobin less than 9.0 gm/dL, or have required transfusion of 3 or more units of red blood cell products in the last 6 months, or any combination of these. \*Patients being treated with a stable dose of hemopoietic growth factors for greater than 4-weeks whose peripheral blood counts exceed these values are eligible for the study. A stable dose of a hematopoeitic growth factor(s) may be continued while the patient is on the study. Patients requiring antibiotic or treatment with antiviral drugs on more than two occasions over the previous 12 months f…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DLT and MTD of Hu MIK Beta 1

Timeframe: 21 days

Trial details

NCT IDNCT00076180

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2010-11-12

View on ClinicalTrials.gov More T-Cell Large Granular Lymphocytic Leukemia trials