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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate

Secondary outcome measures

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%

Hyperthermia

12%

Lymphopenia

12%

Influenza like illness

12%

Fatigue

12%

Influenza

Weight decreased

Carpal tunnel syndrome

Uterine leiomyoma

Hypertension

Anxiety

Joint swelling

Anaemia of pregnancy

Viral upper respiratory tract infection

Skin bacterial infection

Dizziness

Viral infection

Arthralgia

Respiratory tract infection viral

Sinusitis

Infected insect bite

Depressed mood

Pharyngolaryngeal pain

Cough

Joint sprain

Eye irritation

Upper respiratory tract infection

Headache

Depression

Restless legs syndrome

Pain in extremity

Eye pruritus

Contusion

Gastrooesophageal reflux disease

Hypersensitivity

Pregnancy

Herpes zoster

Liver function test abnormal

Abortion threatened

Iron deficiency anaemia

Erythema infectiosum

Tooth disorder

Faecal incontinence

Injection site abscess

White blood cell count decreased

Sensation of heaviness

Syncope

100%

80%

60%

40%

20%

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

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

~4390

Rituximab

1999

Completed Phase 4

~1880

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,168 Total Patients Enrolled

Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)

12 Previous Clinical Trials

2,026 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are included in this clinical trial?

"That is correct, the listed clinical trial on clinicaltrials.gov shows that it is recruiting patients. This particular study was posted on October 20th, 2008 and updated as recently as November 16th, 2020. The aim is to have 208 participants at 2 different sites."

Answered by AI

What medical conditions does Cladribine typically help alleviate?

"Cladribine is most often used to leukocytes in diffuse large b-cell lymphoma (dlbcl) patients. It has also shown efficacy against other blood disorders like b-cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI

Are people with the appropriate medical conditions able to enroll in this study at this time?

"The website clinicaltrials.gov says that this trial is looking for volunteers right now. The listing was made on 20 October 2008, and the information was last updated 16 November 2022."

Answered by AI