New Markers for Minimal Residual Disease in Acute Lymphoblastic Leukemia

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Brief Title

New Markers for Minimal Residual Disease in Acute Lymphoblastic Leukemia

Official Title

Evaluation of New Markers for Minimal Residual Disease in Precursor B Acute Lymphoblastic Leukemia

Brief Summary

      Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the
      overproduction and accumulation of cancerous, immature white blood cells, known as
      lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as
      red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating)
      to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak
      incidence at 2-5 years of age and another peak in old age.
    

Detailed Description

      In recent years, new pieces of information obtained through immunophenotyping, cytogenetics
      and genomic profiling. Chemotherapy resistance have contributed to a better understanding of
      the pathology of this complex disorder and to recognition of subgroups of patients who
      respond differently to therapy.

      The possible impact of the expression of various markers has been studied in ALL.

      In patients with acute leukemia, treatment decisions are based on the status of peripheral
      blood and bone marrow cellularity. This provides a measure of the efficacy of therapy and can
      reveal leukemia relapse. The reliability of morphologic examination of peripheral blood and
      bone marrow largely depends on the hematologist's expertise, and its sensitivity is
      fundamentally limited by the similarities in appearance between leukemic cells and normal
      lympho-hematopoietic progenitors. Therefore, patients in complete morphologic remission may
      still have a large number of residual leukemic cells (potentially up to 1010).

      Minimal residual disease (MRD) is currently the most powerful prognostic indicator in
      Precursor B acute lymphoblastic leukemia (B ALL). MRD analysis can be done by either flow
      cytometric or molecular techniques. Flow cytometric detection holds potential for wider
      applicability than molecular techniques because flow cytometric methods for leukemia diagnosis
      are already established at most cancer centers worldwide.

      Flow cytometric detection of MRD is based on the principle that ALL cells express
      immunophenotypic features that can be used to distinguish them from normal hematopoietic
      cells, including hematogones and activated lymphocytes commonly referred to as Leukemia
      associated immunophenotype (LAIP). In virtually all patients with ALL, leukemia-associated
      immunophenotypes can be defined at diagnosis and then used to monitor MRD during treatment.

      The reliability of flow cytometric MRD assays depends on several factors. The most important
      being the correct marker combination in use. Applicability is limited in some cases by the
      lack of suitable leukemia associated immunophenotype (LAIP) with the currently used markers
      and also antigen immunomodulation post treatment. Therefore, the identification of new
      leukemia markers that are easily detectable and are stably expressed in a large proportion of
      ALL cases should simplify the application of MRD studies, help extend their benefit to all
      patients and possibly enhance the sensitivity of MRD detection.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Level of expression of markers in acute lymphoblastic leukemia.


Condition

Acute Lymphoblastic Leukemia

Intervention

Flow cytometric analysis

Study Arms / Comparison Groups

 ALL patients
Description:  New cases of patients with acute lymphocytic leukemia. Evaluation of markers 15 days after induction.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

50

Start Date

December 2017

Completion Date

October 2019

Primary Completion Date

April 2019

Eligibility Criteria

        Inclusion Criteria:

          -  1. New cases of patients with acute lymphocytic leukemia. 2. Evaluation of markers 15
             days after induction.

        Exclusion Criteria:

          -  Patients died after induction

          -  Patients diagnosed as Non Hodgkin Lymphoma.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Maureen R Farag, Resident, 01013341395, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT03249636

Organization ID

MFARAG


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

Maureen R Farag, Resident, Principal Investigator, Assiut University


Verification Date

August 2017