← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 4

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I can care for myself but may not be able to do heavy physical work.

Select...

I have been diagnosed with a type of Acute Myeloid Leukemia.

Select...

My high-risk MDS did not improve after treatment with hypomethylating agents.

Select...

I am 18 years old or older.

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

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

Primary outcome measures

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 outcome measures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,493 Total Patients Enrolled

Ehab Atallah, MDPrincipal InvestigatorMedical College of Wisconsin

9 Previous Clinical Trials

628 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

Frequently Asked Questions

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

What is the cap on participants within this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, recruitment for this medical trial is presently open; it was first made available on June 14th 2017 and recently updated in April 12th 2022. This research venture seeks 90 participants from a single site."

Answered by AI

Is this examination currently open to enrollment?

"Affirmative. According to clinicaltrials.gov, the trial which was initially posted on June 14th 2017 is open for recruitment now and has been recently updated in April of 2022. 90 participants must be recruited from 1 site for this study to move forward successfully."

Answered by AI

Could you outline the experimental trials done utilizing CLAG-M protocol?

"Research and clinical trials for the Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen have seen a surge in popularity recently. Presently 386 active studies are underway with 92 attaining Phase 3 status. The majority of these investigations are conducted within Saint Louis, Missouri but there are 12646 locations running research on this therapy overall."

Answered by AI

How perilous is the CLAG-M regimen for individuals?

"The CLAG-M regimen was assigned a score of 2 on our safety scale, due to the lack of efficacy data for this Phase 2 trial."

Answered by AI

What condition does the CLAG-M regimen typically attempt to ameliorate?

"The CLAG-M regimen, composed of Cladribine, Cytarabine, Mitoxantrone and G-CSF is a standard practice for treating hemopoietic stem cell transplantation. This therapy can also be implemented to manage bone marrow transfusions, imaging scans and infections."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)

Ehab L Atallah 2017. "Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03150004.

All > Acute Myeloid Leukemia > Aml