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Anti-metabolites

Cladribine Chemotherapy for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Ehab Atallah, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance score 0-3
Morphologically documented: Primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS) or myeloproliferative neoplasm (MPN) or Therapy related AML (t-AML), as defined by World Health Organization (WHO) criteria
Must not have
Active infection not well controlled by antibacterial or antiviral therapy
Acute Promyelocytic Leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 4
Awards & highlights

Summary

This trial will test a new chemotherapy regimen to treat leukemia.

Who is the study for?
Adults (18+) with high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML), including those who've failed hypomethylating agents, can join. They must have an ECOG score of 0-3 and meet specific health criteria like organ function tests. Pregnant women, breastfeeding mothers, and those with uncontrolled infections or Acute Promyelocytic Leukemia are excluded.
What is being tested?
The trial is testing two chemotherapy regimens for AML/MDS: CLAG-M (Cladribine, Cytarabine, Mitoxantrone, G-CSF) and CLLDAC (Cladribine and Cytarabine). It's a phase II study to see how well these treatments work and to understand the genetic factors that affect response to therapy.
What are the potential side effects?
Possible side effects include nausea, vomiting, low blood counts leading to increased infection risk or bleeding problems, liver issues from drug toxicity, fatigue due to anemia or treatment effects. Heart function may also be affected by some drugs used in the regimens.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do heavy physical work.
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I have been diagnosed with a type of Acute Myeloid Leukemia.
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My high-risk MDS did not improve after treatment with hypomethylating agents.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection that isn't responding well to treatment.
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I have been diagnosed with Acute Promyelocytic Leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CLAG-M Arm: Minimal residual disease (MRD) complete remission (CR)
CLLDAC Arm: Minimal residual disease (MRD) complete remission (CR)
CLLDAC Arm: Subjects receiving a second cycle.
+2 more
Secondary study objectives
Prediction of minimal residual disease (MRD) negativity
Prediction of the development of treatment-related toxicities

Trial Design

2Treatment groups
Experimental Treatment
Group I: CLLDAC regimenExperimental Treatment1 Intervention
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Group II: CLAG-M regimenExperimental Treatment1 Intervention
Subject's treatment cycle is 30 days.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
620 Previous Clinical Trials
1,172,484 Total Patients Enrolled
Ehab Atallah, MDPrincipal InvestigatorMedical College of Wisconsin
9 Previous Clinical Trials
590 Total Patients Enrolled

Media Library

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03150004 — Phase 2
Acute Myeloid Leukemia Research Study Groups: CLLDAC regimen, CLAG-M regimen
Acute Myeloid Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT03150004 — Phase 2
Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03150004 — Phase 2
~26 spots leftby Oct 2027
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