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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cladribine
DrugGiven IV
Laboratory Biomarker Analysis
Other interventionCorrelative studies
Rituximab
Biological/VaccineGiven IV
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Treatment (cladribine and rituximab)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Efficacy of rituximab on achievement of complete response after therapy with cladribine
Defined as the absence of hairy cells in the bone marrow or the presence of less than 1 percent atypical cells and the disappearance of all evidence of hairy cell leukemia on physical examination. Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
Time frame
At 12 weeks2
Monitoring the related toxicity for the therapy Grade 3-4
Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
Time frame
Up to 1 year3
Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood
The method of Thall, Simon, Estey as extended by Thall and Sung will be used for efficacy and safety monitoring.
Time frame
Up to 4 weeks after the last dose of rituximab4
Efficacy of rituximab on prolongation of event-free survival
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov