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Anti-metabolites

Oral vs IV Cladribine for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Farhad Ravandi-Kashani, MD
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
Adequate cardiac function with a left ventricular ejection fraction ≥45%.
Patients with newly diagnosed or previously treated HCL who have indication for therapy and are candidates for cladribine therapy (all 3 cohorts).
Must not have
Legal incapacity or limited legal capacity.
Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, malabsorption, or psychiatric illness/social situations that would limit compliance with study requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate how well an oral form of a drug works compared to the already approved IV form.

Who is the study for?
Adults aged ≥18 with Acute Myeloid Leukemia, Myelodysplastic Syndrome, or certain types of leukemia. Must have good kidney and liver function, not be HIV positive or have uncontrolled illnesses. Women must use birth control if of childbearing potential; men must also agree to contraception.
What is being tested?
The study is testing an oral form of the drug Cladribine against the standard IV form for effectiveness in treating specific blood cancers. Participants will receive both forms at different times to compare how their bodies absorb them.
What are the potential side effects?
Cladribine can cause side effects like infections due to a weakened immune system, nausea, fever, rash, fatigue and may affect liver enzymes. Specific side effects depend on individual reactions and dosage received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart pumps blood effectively with an ejection fraction of 45% or higher.
Select...
I have hairy cell leukemia and need treatment, qualifying for cladribine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am legally unable to make my own decisions.
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I do not have any uncontrolled illnesses that could interfere with the study.
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I cannot swallow pills without altering them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
Group I: Cohort 3 (All-Oral HCL)Experimental Treatment1 Intervention
Participants will all receive the same dose of oral cladribine over the course of 5 days.
Group II: Cohort 2 (PK)Experimental Treatment1 Intervention
Participants will only receive 1 dose of oral cladribine, followed by 4 daily doses of cladribine by vein
Group III: Cohort 1 (Pilot)Experimental Treatment1 Intervention
Participants will only receive 1 dose of oral cladribine, followed by 4 daily doses of cladribine by vein
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
2014
Completed Phase 4
~4410

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,569 Total Patients Enrolled
464 Trials studying Leukemia
31,735 Patients Enrolled for Leukemia
Farhad Ravandi-Kashani, MDPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
905 Total Patients Enrolled
15 Trials studying Leukemia
893 Patients Enrolled for Leukemia
~20 spots leftby Dec 2025
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