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Anti-metabolites

Cladribine + Rituximab for Hairy Cell Leukemia

Phase 2
Waitlist Available
Led By Robert J Kreitman, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status (78) of 0-3
Creatinine less than or equal to 1.5 or creatinine clearance greater than or equal to 60 ml/ml
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months after cladribine or delayed rituximab for 1 year, then every 6 months until 2.5 years, then yearly
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding rituximab to cladribine improves outcomes for hairy cell leukemia.

Who is the study for?
This trial is for adults with Hairy Cell Leukemia (HCL) who have had no more than one prior treatment with cladribine. Participants should not be pregnant, must agree to use birth control, and cannot have untreated infections or certain other health conditions. Those with the variant form of HCL (HCLv) may also join even if they've had rituximab before.
What is being tested?
The study tests whether giving rituximab at the same time as cladribine is better than waiting until after cladribine treatment when minimal residual disease (MRD) might be detected. Patients will either receive both drugs simultaneously or just cladribine first, followed by rituximab later if MRD appears.
What are the potential side effects?
Cladribine can cause fever, fatigue, infection risk due to low blood cell counts, and nausea. Rituximab may lead to infusion reactions like chills and fever; it can also affect blood cells and increase infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do heavy physical work.
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My kidney function, measured by creatinine levels, is normal.
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I am 18 years old or older.
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I agree to use birth control during and for a year after treatment.
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I have not had rituximab unless I have variant hairy cell leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months after cladribine or delayed rituximab for 1 year, then every 6 months until 2.5 years, then yearly
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months after cladribine or delayed rituximab for 1 year, then every 6 months until 2.5 years, then yearly for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response Rate
Secondary study objectives
MRD-free survival and disease-free survival
Overall response and MRD
T- and B-cells
+7 more

Side effects data

From 2011 Phase 3 trial • 867 Patients • NCT00641537
24%
Back pain
20%
Neutropenia
12%
Lymphopenia
12%
Influenza like illness
12%
Fatigue
12%
Influenza
12%
Hyperthermia
6%
Depression
6%
Carpal tunnel syndrome
6%
Viral upper respiratory tract infection
6%
Uterine leiomyoma
6%
Upper respiratory tract infection
6%
Pain in extremity
6%
Headache
6%
Arthralgia
6%
Anxiety
6%
Hypertension
6%
Anaemia of pregnancy
6%
Eye irritation
6%
Eye pruritus
6%
Gastrooesophageal reflux disease
6%
Hypersensitivity
6%
Respiratory tract infection viral
6%
Viral infection
6%
Herpes zoster
6%
Sinusitis
6%
Infected insect bite
6%
Skin bacterial infection
6%
Contusion
6%
Joint sprain
6%
Liver function test abnormal
6%
Weight decreased
6%
Dizziness
6%
Joint swelling
6%
Pharyngolaryngeal pain
6%
Cough
6%
Restless legs syndrome
6%
Pregnancy
6%
Depressed mood
6%
Abortion threatened
6%
Iron deficiency anaemia
6%
Erythema infectiosum
6%
Tooth disorder
6%
Faecal incontinence
6%
Injection site abscess
6%
White blood cell count decreased
6%
Sensation of heaviness
6%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cladribine 3.5 mg/kg/No Treatment
Cladribine 5.25 mg/kg/No Treatment
Cladribine Low/Placebo (LLPP)
Cladribine High Dose/Placebo (HLPP)
Cladribine Low/Low Dose (LLLL)
Cladribine High/Low Dose (HLLL)
Placebo/Cladribine Low Dose (PPLL)
Placebo/No Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 3Experimental Treatment2 Interventions
Non-randomized group receving Cladribine with immediate Rituximab (before rather than after the 1st of the 5 daily doses of cladribine on day 1)
Group II: 1Experimental Treatment2 Interventions
Cladribine with immediate Rituximab
Group III: 2Active Control2 Interventions
Cladribine with Rituximab delayed by at least 6 months after Cladribine if and when minimal residual disease is detected
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
2014
Completed Phase 4
~4410
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,022,967 Total Patients Enrolled
Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
12 Previous Clinical Trials
2,180 Total Patients Enrolled

Media Library

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00923013 — Phase 2
Hairy Cell Leukemia Research Study Groups: 3, 1, 2
Hairy Cell Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT00923013 — Phase 2
Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00923013 — Phase 2
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