NCT04554381

Brief Summary

The aim of this study is to assess JL1 expression by flow cytometric immunophenotyping in patients with B-cell Acute Lymphoblastic Leukemia (ALL) and to correlate it with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2020

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

September 14, 2020

Last Update Submit

September 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation and assessment of JL1 expression in B-cell Acute Lymphoblastic Leukemia.

    Correlatin of this marker with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.

    Baseline

Study Arms (2)

JL1

EXPERIMENTAL

JL1 on acute leukemia

Biological: JL1 antigen

JL1 and acute leukemia

EXPERIMENTAL

Assesment of JL1 expression on acute leukemia

Biological: JL1 antigen

Interventions

JL1 antigenBIOLOGICAL

we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.

JL1JL1 and acute leukemia

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed B-cell ALL.
  • Age group: both pediatric patients (\< 18 years old) and adult patients (\> 18 years old) will be included in our study.

You may not qualify if:

  • \. Patients with other types of hematologic neoplasms. 2 .Relapsed patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer J. 2017 Jun 30;7(6):e577. doi: 10.1038/bcj.2017.53.

    PMID: 28665419BACKGROUND
  • Park YS, Park SH, Park SJ, Kim Y, Jang KT, Ko YH, Lee MW, Huh JR, Park CS. Expression of JL1 is an effective adjunctive marker of leukemia cutis. Arch Pathol Lab Med. 2010 Jan;134(1):95-102. doi: 10.5858/2008-0699-OAR.1.

    PMID: 20073611BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

JL1 antigen

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Zeinab Galal, medical resident

CONTACT

Douaa Mohamed, Professor

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

October 13, 2020

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

September 18, 2020

Record last verified: 2020-09