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Anti-metabolites
Oral vs IV Cladribine for Acute Myeloid Leukemia
Phase 1
Waitlist Available
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Side effects data
From 2011 Phase 3 trial • 867 Patients • NCT0064153724%
Back pain
20%
Neutropenia
12%
Hyperthermia
12%
Lymphopenia
12%
Influenza like illness
12%
Fatigue
12%
Influenza
6%
Skin bacterial infection
6%
Weight decreased
6%
Hypertension
6%
Anxiety
6%
Respiratory tract infection viral
6%
Uterine leiomyoma
6%
Viral infection
6%
Arthralgia
6%
Anaemia of pregnancy
6%
Viral upper respiratory tract infection
6%
Infected insect bite
6%
Dizziness
6%
Sinusitis
6%
Joint swelling
6%
Carpal tunnel syndrome
6%
Depressed mood
6%
Pharyngolaryngeal pain
6%
Cough
6%
Joint sprain
6%
Eye irritation
6%
Upper respiratory tract infection
6%
Headache
6%
Depression
6%
Restless legs syndrome
6%
Pain in extremity
6%
Eye pruritus
6%
Contusion
6%
Gastrooesophageal reflux disease
6%
Hypersensitivity
6%
Pregnancy
6%
Herpes zoster
6%
Liver function test abnormal
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
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
~4390
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,778 Total Patients Enrolled
Farhad Ravandi-Kashani, MDPrincipal InvestigatorM.D. Anderson Cancer Center
15 Previous Clinical Trials
805 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What health risks have been associated with participation in Cohort 1 (Pilot)?
"Because of the limited data on safety and efficacy for Cohort 1 (Pilot), our team has assigned a score of 1 to its overall security."
Answered by AI
Are there any available vacancies for participants in this medical trial?
"As indicated on clinicaltrials.gov, this medical study is not actively looking for volunteers at the present time; however it was initially posted on February 28th 2024 and most recently updated on September 11th 2023. Fortunately, there are 1,649 other trials that may currently have open recruitment slots presently available."
Answered by AI
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