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Anti-metabolites
Cladribine + Rituximab for Hairy Cell Leukemia
Phase 2
Recruiting
Led By Farhad Ravandi-Kashani
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and older
Performance status =< 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing the side effects and efficacy of two drugs, cladribine and rituximab, in treating patients with hairy cell leukemia.
Who is the study for?
This trial is for adults with hairy cell leukemia who may have had one prior therapy. They must not be pregnant and should agree to use birth control. Participants need a performance status of <=3, acceptable kidney and liver function tests, and no recent investigational drugs or active infections.Check my eligibility
What is being tested?
The study is testing the combination of Cladribine (a chemotherapy drug) with Rituximab (an immunotherapy antibody) to see if they work better together in treating hairy cell leukemia by killing cancer cells or stopping their growth.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by Rituximab, such as fever and chills, as well as typical chemotherapy-related issues from Cladribine like nausea, fatigue, infection risk increase due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself but cannot do any physical work.
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My leukemia was confirmed through a bone marrow test.
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My condition has returned, but I've only had one prior treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood
Therapeutic procedure
Efficacy of rituximab on prolongation of event-free survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cladribine and rituximab)Experimental Treatment3 Interventions
Patients receive cladribine IV over 2 hours QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Cladribine
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,855 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,171 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
556 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV, hepatitis B, or hepatitis C.I am 18 years old or older.My cancer has spread to my brain or spinal cord.My heart condition severely limits my daily activities.I can take care of myself but cannot do any physical work.My leukemia was confirmed through a bone marrow test.I currently have an active infection.My condition has returned, but I've only had one prior treatment.I haven't had chemotherapy in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cladribine and rituximab)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest number of participants involved in this trial?
"Affirmative. Clinicaltrials.gov's information attests that this clinical trial is currently looking for volunteers and commenced recruitment on June 10th 2004 with the latest update occurring on September 22nd 2022. 150 participants need to be recruited from a single site."
Answered by AI
What kind of health risks are associated with Cladribine therapy?
"As this is a Phase 2 trial, where safety has been established but efficacy not yet proven, the team at Power assigned Cladribine a score of two."
Answered by AI
Are there any openings available for participants in this research?
"Data hosted on clinicaltrials.gov affirms that this medical experiment, initially listed on June 10th 2004, is presently recruiting patients. The description was recently revised on September 22nd 2022."
Answered by AI
What indications are usually treated with Cladribine?
"Cladribine is an effective treatment for dlbcl, as well as other conditions such b-cell lymphomas, polyangium and pemphigus vulgaris."
Answered by AI
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