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Anti-metabolite

cytarabine for Leukemia

Phase 2
Waitlist Available
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia (AML).

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Remission (CR) Rate (Including CR With Incomplete Recovery)
Secondary outcome measures
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Other outcome measures
Correlation Between Pre-study Cytogenetic Features and Response
Overall Survival (OS)
Relapse-free Survival (RFS)

Side effects data

From 2011 Phase 3 trial • 170 Patients • NCT00002766
17%
Fatigue
16%
Hypokalemia
15%
Febrile neutropenia
15%
Hypophosphatemia
13%
Pain, other
13%
Abdominal pain/cramping
11%
Stomatitis/pharyngitis
8%
Thrombosis
8%
Dyspnea
8%
Hypomagnesemia
7%
Dizziness
7%
Bilirubin
6%
Prothrombin Time
6%
Vision-blurred vision
6%
SGPT (ALT)
6%
Hyponatremia
6%
Ileus (or neuroconstipation)
6%
Anorexia
4%
Infection/Febrible Neutrophil-Other
3%
Hemorrhage, other
2%
Platelets
2%
Neuropathy-motor
2%
infection
2%
Pulmonary, other
2%
Renal failure
2%
Dehydration
2%
Adult respiratory disorder
1%
Gastrointestinal, other
1%
Epistaxis
1%
Diarrhea
1%
Constipation
1%
Leukocytes
1%
Dermatology, skin other
1%
Neutrophils (Leukemia)
1%
Chest pain
1%
Syncope
1%
Supraventricular tachycardia
1%
Headache
1%
disseminated intravascular coagulation
1%
Cardiovascular, Arrhythmia other
1%
Ascites
1%
ALT, SGPT
1%
Pancreatitis
1%
Supravent arrhythmia
1%
Neutrophils
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-20
All-2

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment3 Interventions
Induction (1 cycle): pravastatin 1280 mg/d PO D 1-8 idarubicin 12 mg/m2/d IV D 4-6 cytarabine 1.5 g/m2/d continuous IV D 4-7 Consolidation (up to 2 cycles): pravastatin 1280 mg/d PO D 1-6 idarubicin 12 mg/m2/d IV D 4-5 cytarabine 1.5 g/m2/d continuous IV D 4-5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cytarabine
1997
Completed Phase 3
~10270
idarubicin
2007
Completed Phase 3
~5130
pravastatin sodium
2000
Completed Phase 3
~1370

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,696 Total Patients Enrolled
33 Trials studying Leukemia
9,204 Patients Enrolled for Leukemia
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,055 Total Patients Enrolled
33 Trials studying Leukemia
9,204 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,646 Previous Clinical Trials
40,930,912 Total Patients Enrolled
1,511 Trials studying Leukemia
379,567 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BloodJournal
Comparable Outcomes of Patients Eligible Vs Ineligible for SWOG Leukemia Studies
Statler, Abby, Megan Othus, Harry P. Erba, Thomas R. Chauncey, Jerald P. Radich, Steven Coutre, Anjali Advani, et al.. 2018. “Comparable Outcomes of Patients Eligible Vs Ineligible for SWOG Leukemia Studies”. Blood. American Society of Hematology. doi:10.1182/blood-2018-01-826693.
clinicaltrials.govStudy
S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
2009. "S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00840177.
~7 spots leftby Apr 2025
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