Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia (NCT00412594) | Clinical Trial Compass
RecruitingPhase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
United States150 participantsStarted 2004-06-10
Plain-language summary
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.
Who can participate
Age range
18 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:
* 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)
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.
1This trial combines cladribine with rituximab for hairy cell leukemia — since cladribine alone is already a standard treatment, can you explain what benefit adding rituximab might offer me specifically, and what extra risks come with combining these two drugs?
2Since this is a Phase 2 trial, the researchers are still studying whether this combination works and how safe it is — does that change your recommendation compared to me just receiving standard cladribine treatment on its own?
3One of the main things being measured is whether rituximab can wipe out minimal residual disease in the bone marrow after cladribine — what does that actually mean for my long-term outlook, and how would we know if it's working?
4The trial is tracking serious Grade 3-4 side effects as a key safety outcome — what kinds of toxicities at that level of severity have been seen so far with this combination, and how would those be managed if they happened to me?
5Since this trial includes patients with recurrent hairy cell leukemia, would my situation — whether this is my first diagnosis or a relapse — affect whether this trial might even be worth discussing as an option for my care?
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
1
Efficacy of rituximab on achievement of complete response after therapy with cladribine
Timeframe: At 12 weeks
2
Monitoring the related toxicity for the therapy Grade 3-4
Timeframe: Up to 1 year
3
Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood
Timeframe: Up to 4 weeks after the last dose of rituximab
4
Efficacy of rituximab on prolongation of event-free survival
Timeframe: Up to 1 year
5
Efficacy of rituximab on prolongation of overall survival