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Anti-metabolites

Chemotherapy Combinations for Acute Myeloid Leukemia

Phase 3
Waitlist Available
Led By James Foran
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi
Serum creatinine =< grade 1
Must not have
History of any lymphoproliferative disorder
History of active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatment
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing two different chemotherapy combinations to see which is more effective in treating older patients with newly diagnosed acute myeloid leukemia.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Chemotherapy drugs like those tested may cause side effects such as nausea, vomiting, fatigue, hair loss, increased risk of infection due to low blood cell counts, liver problems indicated by changes in liver enzymes levels, and potential heart damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show I am currently in remission.
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My kidney function, measured by creatinine, is normal or slightly increased.
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I have a matching donor for my treatment.
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I have maintained my complete remission status.
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My cancer is in complete remission.
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My liver tests are within normal limits.
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I have been newly diagnosed with AML and can undergo intensive chemotherapy.
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My leukemia developed from a previous blood disorder.
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My kidney function is good, with a GFR of 60 ml/min or more.
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I may need a spinal tap to check for brain involvement.
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I have recovered from any serious infections caused by initial treatments.
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My white blood cell count is high enough for decitabine treatment.
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My heart pumps blood effectively.
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My bilirubin and creatinine levels are within normal limits.
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I can care for myself but may not be able to do heavy physical work, especially if I'm over 70.
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My heart pumps blood effectively, meeting the minimum health standard.
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My lung function, specifically for absorbing gases, is above 40% and I don't have lung disease symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of disorders related to lymphocyte proliferation.
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I have a history of cancer.
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I am currently being treated for another cancer.
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I currently have an infection that isn't under control.
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My leukemia is confirmed to be APL by specific genetic tests.
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My leukemia has transformed into a more aggressive form.
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I have been treated for MDS with specific medications before.
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My cancer has spread to my brain or spinal cord.
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I have been treated for a blood disorder with specific medications.
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I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Disease-free Survival for Maintenance
Overall Survival by Donor Status
Proportion of Patients With Complete Remission
Other study objectives
Baseline QOL Scores by Treatment Completion Status
Change in Health-related QOL Over Time
Change in QOL Post Transplant From Baseline
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: B (Induction: clofarabine; Consolidation: clofarabine; Maintenance: decitabine or transplant)Experimental Treatment3 Interventions
See Detailed Description
Group II: A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant)Active Control4 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic hematopoietic stem cell transplantation
2016
Completed Phase 2
~290
Clofarabine
2007
Completed Phase 3
~1130
Decitabine
2004
Completed Phase 3
~1720

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
150,868 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
121 Previous Clinical Trials
179,470 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,443 Total Patients Enrolled
James ForanPrincipal InvestigatorEastern Cooperative Oncology Group

Media Library

Clofarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02085408 — Phase 3
Acute Myeloid Leukemia Research Study Groups: A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant), B (Induction: clofarabine; Consolidation: clofarabine; Maintenance: decitabine or transplant)
Acute Myeloid Leukemia Clinical Trial 2023: Clofarabine Highlights & Side Effects. Trial Name: NCT02085408 — Phase 3
Clofarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02085408 — Phase 3
~49 spots leftby Dec 2025
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