Advertisement

Topics

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

2017-05-12 13:38:21 | BioPortfolio

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 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.

Study Design

Conditions

Acute Myeloid Leukemia

Intervention

CLAG-M regimen

Status

Not yet recruiting

Source

Medical College of Wisconsin

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-05-12T13:38:21-0400

Clinical Trials [2713 Associated Clinical Trials listed on BioPortfolio]

CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)

The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate). The CLAG regimen is a combination of the chemothe...

A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia

The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec) in patients with AML.

Lintuzumab-Ac225 in Combination With CLAG-M Chemotherapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This is a prospective, single-center phase I clinical study aimed at determining the maximum-tolerated dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy in the ma...

Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML

This study will evaluate the investigational drug Midostaurin in various doses given with ATRA and CLAG chemotherapy. Midostaurin is a FLT3 inhibitor that is activated or overexpressed in ...

BI 836858 Dose Escalation in Refractory or Relapsed Acute Myeloid Leukemia

Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. The trial will examine whether monotherapy with BI 836858 is ...

PubMed Articles [7335 Associated PubMed Articles listed on BioPortfolio]

Analysis of Efficacy and Prognostic Factors of CLAG Treatment in Chinese Patients with Refractory or Relapsed Acute Myeloid Leukemia.

The aim of this work was to investigate the efficacy and predictive factors of CLAG treatment in refractory or relapsed (R/R) acute myeloid leukemia (AML) patients.

Primary Philadelphia chromosome positive acute myeloid leukemia: A case report.

Philadelphia chromosome positive acute myeloid leukemia (Ph+ AML) is a rare subtype of AML that is now included as a provisional entity in the 2016 revised WHO classification of myeloid malignancies. ...

Risk of acute myeloid leukemia and myelodysplastic syndrome after autotransplants for lymphomas and plasma cell myeloma.

Exposures to DNA-damaging drugs and ionizing radiations increase risks of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Perianal Infections in Children With Acute Myeloid Leukemia: A Report From the Canadian Infection in Acute Myeloid Leukemia Research Group.

Among 235 children with acute myeloid leukemia, 17 experienced 19 perianal infections. Among 12 episodes with definite abscess, 75% were severely neutropenic. Sixteen diagnostic imaging evaluations we...

Identification of the UBA2-WTIP fusion gene in acute myeloid leukemia.

Identifying and targeting oncogenic fusion genes have revolutionized the treatment of leukemia, such as PML-RARα fusion gene in acute promyelocytic leukemia. Here we identified an intrachromosomal fu...

Medical and Biotech [MESH] Definitions

A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.

More From BioPortfolio on "Efficacy and Pharmacogenomics of Salvage CLAG-M Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial