Efficacy and Pharmacogenomics of Salvage CLAG-M Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03150004|
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: CLAG-M regimen||Phase 2|
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.
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.
- To determine the progression free survival (PFS) and overall survival (OS) of patients treated with CLAG-M chemotherapy regimen.
- To study the pharmacogenomics of patients receiving CLAG-M chemotherapy and determine its influence on survival, CR rate and MRD negativity.
- Determination of disease- or patient-related factors that predict MRD negativity and survival with CLAG-M.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Pharmacogenomics of Salvage CLAG-M Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: CLAG-M regimen
Patients treatment cycle is 30 days.
Drug: CLAG-M regimen
Patients will be started on CLAG-M regimen, which consists of the following:
- Minimal residual disease (MRD) complete remission (CR) rate after CLAG-M chemotherapy, using bone marrow aspirate/biopsy. [ Time Frame: Day 30 (+/- 5 days) ]Repeat bone marrow study will be obtained after the completion of CLAG-M therapy at day 30 or when absolute neutrophil count (ANC) recovers to >1000 cells/cu.mm.
- Minimal residual disease (MRD) complete remission (CR) rate after CLAG-M chemotherapy using flow cytometery. [ Time Frame: Day 30 (+/- 5 days) ]MRD assessment by flow cytometry will be done on patients achieving CR or CRp at the Wisconsin Diagnostic Laboratory. The test is performed using 8-color flow cytometry (FC). Briefly, EDTA-anticoagulated bone marrow aspirates are lysed and cell suspensions are prepared for incubation with 8 different, fluorochrome-labeled antibodies per tube. Antibodies analyzed across multiple tubes include: CD7, CD11b, CD13, CD14, CD15, CD22, CD33, CD34, CD36, CD38, CD45, CD56, CD64, CD117, and HLA-DR.
- Pharmacogenomics assessment through affimetry DMET assay. [ Time Frame: Day -30 to day 0 ]Genotyping with the DMET Plus array (Drug Metabolizing Enzymes and Transporters) will be performed using the DNA extracted from blood through Qiagen Blood and Cell Culture DNA extraction kit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150004
|Contact: Medical College of Wisconsin Clinical Cancer Centeremail@example.com|
|United States, Wisconsin|
|Froedtert & the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Medical College of Wisconsin Clinical Cancer Center 414-805-8900 firstname.lastname@example.org|
|Principal Investigator:||Ehab Atallah, MD||Medical College of Wisconsin|