Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cladribine
- Laboratory Biomarker Analysis
- Rituximab
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov