Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Launched by M.D. ANDERSON CANCER CENTER · Dec 15, 2006

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two treatments, cladribine and rituximab, to see how effective they are in treating patients with hairy cell leukemia, a type of blood cancer. Cladribine is a chemotherapy drug that helps kill cancer cells, while rituximab is an immunotherapy that helps the body’s immune system recognize and attack the cancer. The goal is to find out if using these two treatments together can help more patients than using them separately.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of hairy cell leukemia, either newly diagnosed or having experienced a relapse after at most one previous treatment. Other health requirements include having certain blood test results within specific limits and being able to perform daily activities without major limitations. Participants can expect to receive these treatments and be closely monitored for any side effects as part of the study. It's important to note that women who could become pregnant will need to use effective birth control during the trial. If you or a loved one is interested, it’s a great opportunity to contribute to important research while receiving care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years and older
• • Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination
• • Patients with relapsed disease are eligible if they have had no more than one prior therapy
• • Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
• • Performance status =\< 3
• • Creatinine less than or equal to 2.0 unless related to the disease
• • Bilirubin less than or equal to 3.0
• • Transaminases less than or equal 3 x upper limit of normal unless related to the disease
• • No prior investigational agent in the 4 weeks prior to initiation of therapy
• Exclusion Criteria:
• • Unable or unwilling to sign the consent form
• • Known infection with human immunodeficiency virus (HIV), hepatitis B or C
• • Presence of active infection
• • Presence of central nervous system (CNS) metastases
• • New York Heart Association classification III or IV heart disease
• • Prior chemotherapy (last 4 weeks)