Efficacy and Pharmacogenomics of Salvage CLAG-M Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia

  • STATUS
    Recruiting
  • End date
    Oct 1, 2029
  • participants needed
    90
  • sponsor
    Medical College of Wisconsin
Updated on 1 May 2022
cytarabine
filgrastim
ejection fraction
granulocyte colony stimulating factor
direct bilirubin
mitoxantrone
secondary acute myeloid leukemia
cladribine
hemolysis
colony stimulating factor

Summary

This is a prospective phase II clinical study to be conducted at the Medical College of Wisconsin. After meeting the study criteria and enrollment, patients will be treated with Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) chemotherapy and followed at periodic intervals to determine the primary and secondary objectives.

Description

STUDY RATIONALE:

The optimal treatment regimen for relapsed/refractory acute myeloid leukemia (AML) is unknown. Although several chemotherapy options are available, there is no universally accepted regimen to date. One such regimen is CLAG-M (Cladribine, Cytarabine, Mitoxantrone, G-CSF) that has been frequently used at our center. However, it is difficult to predict which patients are likely to respond to CLAG-M or experience treatment-related toxicities. In patients with newly diagnosed AML, studies have demonstrated that achievement of minimal residual disease negative CR is associated with a better overall survival. However, this has not been clearly studied in patients with relapsed-refractory AML. Through this study, we aim to demonstrate the influence of achieving MRD negative CR on survival of patients with relapsed/refractory AML treated with CLAG-M. In addition to the conventionally used predictive factors, we aim to incorporate pharmacogenomics to assess the efficacy and toxicity of therapy.

PRIMARY OBJECTIVE:

To determine the complete remission (CR) rate and achievement of minimal residual disease (MRD) negativity after treatment with salvage CLAG-M chemotherapy regimen in patients with relapse/refractory and secondary AML.

SECONDARY OBJECTIVES:

  1. To determine the progression free survival (PFS) and overall survival (OS) of patients treated with CLAG-M chemotherapy regimen.
  2. To study the pharmacogenomics of patients receiving CLAG-M chemotherapy and determine its influence on survival, CR rate and MRD negativity.
  3. Determination of disease- or patient-related factors that predict MRD negativity and survival with CLAG-M.

Details
Condition Acute Myeloid Leukemia
Treatment CLAG-M regimen, Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen
Clinical Study IdentifierNCT03150004
SponsorMedical College of Wisconsin
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 years at the time of informed consent
Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS) or therapy related AML (t-AML), as defined by World Health Organization (WHO) criteria
Patients must meet one of the following criteria
In first or subsequent relapse or refractory status, with or without prior hematopoietic stem cell transplant (HSCT) OR
Patients with MDS transformed to AML will be eligible even if they had not received prior therapy for AML
Eastern Cooperative Oncology Group (ECOG) performance score 0-2
Patients must meet the following clinical laboratory criteria: Direct bilirubin ≤ 1.5 X the upper limit of the normal range (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN unless related to AML or Gilbert syndrome or hemolysis. Calculated creatinine clearance ≥30 mL/min
Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria

Acute Promyelocytic Leukemia
Pregnant or breast feeding women
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
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