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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)

NCT03150004 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-03-30

Study results available
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Summary

This is a prospective phase II clinical study planned to be conducted at the Medical College of Wisconsin (MCW). After meeting the study criteria and enrollment, patients will be treated with a cladribine based salvage regimen and followed at periodic intervals to determine the primary and secondary objectives.

Conditions

Interventions

DRUG

Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen

Subjects will be started on CLAG-M regimen, which consists of the following: * Cladribine 5 mg/m\^2 IV over two hours on days 1-5; * Cytarabine 2 gm/m\^2 IV over four hours on days 1-5 * Mitoxantrone 10 mg/m\^2 IV on days 1-3; * G-CSF at a dose of 300 μg on days 0-5.

DRUG

Cladribine and Cytarabine (CLLDAC) Regimen

* Cladribine 5 mg/m\^2 IV over two hours on days 1-5; * Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Ehab Atallah, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2025-03-14
Completion
2025-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150004 on ClinicalTrials.gov