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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 4

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met