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Anti-metabolites

Chemotherapy Combinations for Acute Myeloid Leukemia

Q: Could you explain the risks associated with clofarabine?

We have rated clofarabine as a 3 in terms of safety. This is because it has reached Phase 3 clinical trials, meaning that there is evidence of its efficacy and that it has undergone multiple rounds of testing for safety.

Q: What other medical research exists on clofarabine?

At the moment, there are 382 clinical trials studying clofarabine with 79 of those being in Phase 3. A large number of these studies are based out of Providence, <a href="https://www.withpower.com/clinical-trials/rhode-island">Rhode island</a>; however, research is taking place at 13161 locations globally.

Q: How many people are participating in this clinical trial?

Unfortunately, this clinical trial is no longer admitting patients. The trial was initially posted on December 28th, 2010 and last updated on February 23rd, 2021. However, there are 1662 other trials for <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myeloid, acute that are still enrolling patients as well as 382 studies involving clofarabine.

Q: How many different hospitals or research facilities are coordinating this trial?

One hundred medical sites are currently recruiting patients for this trial, with locations in Jacksonville, Peoria and Lewes among others. If you enroll, it may be helpful to choose the site closest to your home to cut down on travel time.

Q: Are people still being signed up for this experiment?

This clinical trial is not recruiting patients at this present moment. The first posting was on December 28th, 2010 and the most recent update was February 23rd, 2021. For those looking for other studies, there are 1662 trials actively recruiting <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myeloid, acute patients and 382 clofarabine trials with open recruitment at the moment.

Q: What conditions does clofarabine typically treat?

Clofarabine is mostly used to treat refractory anemia, but can also help patients with langerhans cell histiocytosis, meningeal <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, and intermediate-2 ipss risk category.

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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Secondary outcome measures

Disease-free Survival for Maintenance

Overall Survival by Donor Status

Proportion of Patients With Complete Remission

Other outcome measures

Baseline QOL Scores by Treatment Completion Status

Change in Health-related QOL Over Time

Change in QOL Post Transplant From Baseline

+9 more

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

Decitabine

2004

Completed Phase 3

~1680

Allogeneic hematopoietic stem cell transplantation

2016

Completed Phase 2

~290

Clofarabine

2007

Completed Phase 3

~1130

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor

268 Previous Clinical Trials

150,103 Total Patients Enrolled

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,195 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,426 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the risks associated with clofarabine?

"We have rated clofarabine as a 3 in terms of safety. This is because it has reached Phase 3 clinical trials, meaning that there is evidence of its efficacy and that it has undergone multiple rounds of testing for safety."

Answered by AI

What other medical research exists on clofarabine?

"At the moment, there are 382 clinical trials studying clofarabine with 79 of those being in Phase 3. A large number of these studies are based out of Providence, Rhode island; however, research is taking place at 13161 locations globally."

Answered by AI

How many people are participating in this clinical trial?

"Unfortunately, this clinical trial is no longer admitting patients. The trial was initially posted on December 28th, 2010 and last updated on February 23rd, 2021. However, there are 1662 other trials for leukemia, myeloid, acute that are still enrolling patients as well as 382 studies involving clofarabine."

Answered by AI

How many different hospitals or research facilities are coordinating this trial?

"One hundred medical sites are currently recruiting patients for this trial, with locations in Jacksonville, Peoria and Lewes among others. If you enroll, it may be helpful to choose the site closest to your home to cut down on travel time."

Answered by AI

Are people still being signed up for this experiment?

"This clinical trial is not recruiting patients at this present moment. The first posting was on December 28th, 2010 and the most recent update was February 23rd, 2021. For those looking for other studies, there are 1662 trials actively recruiting leukemia, myeloid, acute patients and 382 clofarabine trials with open recruitment at the moment."

Answered by AI

What conditions does clofarabine typically treat?

"Clofarabine is mostly used to treat refractory anemia, but can also help patients with langerhans cell histiocytosis, meningeal leukemia, and intermediate-2 ipss risk category."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

2011. "Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02085408.

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