Chemotherapy Combinations for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+268 other locations

Overseen by James Foran

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eastern Cooperative Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

Eligibility Criteria

This trial is for older adults newly diagnosed with various types of acute myeloid leukemia (AML), who have good organ function and performance status, and no active infections or other cancers. They must not have had previous AML treatments except hydroxyurea or leukapheresis, and should be able to follow the treatment plan reliably.

Inclusion Criteria

My kidney function is good, with a GFR of 60 ml/min or more.

I may need a spinal tap to check for brain involvement.

I have recovered from any serious infections caused by initial treatments.

Exclusion Criteria

I have been treated for a blood disorder with specific medications.

I have a weak immune system and may react badly to strong immune treatments.

I have a history of disorders related to lymphocyte proliferation.

Treatment Details

Interventions

• Clofarabine (Anti-metabolites)
• Cytarabine (Anti-metabolites)
• Daunorubicin (Anti-tumor antibiotic)
• Decitabine (DNA Methyltransferase Inhibitor)

Trial Overview The study compares clofarabine with daunorubicin hydrochloride and cytarabine followed by either decitabine or observation. It aims to find out which chemotherapy combination is more effective in stopping cancer cell growth in patients with AML.

Participant Groups

Group I: B (Induction: clofarabine; Consolidation: clofarabine; Maintenance: decitabine or transplant) Experimental Treatment 3 Interventions

See Detailed Description

Group II: A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant) Active Control 4 Interventions

See Detailed Description

Clofarabine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Clolar for:

• Acute lymphoblastic leukemia (ALL) in pediatric patients

🇪🇺 Approved in European Union as Evoltra for:

• Acute lymphoblastic leukemia (ALL) in pediatric patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alabama at Birmingham Birmingham, AL

University of Arizona Health Sciences Center Tucson, AZ

The Medical Center of Aurora Aurora, CO

Exempla Saint Joseph Hospital Denver, CO

More Trial Locations

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group Lead Sponsor

ECOG-ACRIN Cancer Research Group Lead Sponsor

National Cancer Institute (NCI) Collaborator

References