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 [2517 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 [7497 Associated PubMed Articles listed on BioPortfolio]

Acute external otitis as debut of acute myeloid leukemia - A case and review of the literature.

Acute leukemia is a well known childhood cancer. The relation between leukemia and otological symptoms has long been established but is highly rare as a debut symptom of leukemia. External otitis is a...

A Modified Post-Transplant Cyclophosphamide (PT-CY) Regimen, for Unmanipulated Haploidentical Marrow Transplantation, in Acute Myeloid Leukemia: a Multicenter Study.

We are reporting a modified post-transplant cyclophosphamide (PT-CY) regimen, for unmanipulated haploidentical marrow transplants (HAPLO), in 150 patients with acute myeloid leukemia (AML). All patien...

The importance of meaningful activity in people living with acute myeloid leukemia.

The symptom burden of acute myeloid leukemia (AML) and its treatment can accelerate physical deconditioning and impair mobility and quality of life. In the present study, we explore the subjective exp...

Widespread use of measurable residual disease in acute myeloid leukemia practice.

Measurable residual disease (MRD) has prognostic importance for patients with acute myeloid leukemia (AML). How leukemia providers incorporate MRD into routine practice remains undefined.

Measurable residual disease, conditioning regimen intensity and age predict outcome of allogeneic hematopoietic cell transplantation for acute myeloid leukemia in first remission: a registry analysis of 2292 patients by the Acute Leukemia Working Party European Society of Blood and Marrow Transplantation.

Patients with acute myeloid leukemia (AML) in morphological first complete remission (CR1) pre-allogeneic hematopoietic cell transplantation (HCT) may have measurable residual disease (MRD) by molecul...

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