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Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT05898477
Collaborator
(none)
2,000
Enrollment
1
Location
26
Anticipated Duration (Months)
76.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in patients with lymphoma to identify possible therapeutic strategies to improve overall survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective, multi-institutional study focused on describing the clinical features, laboratory parameters, treatments, and outcomes among individuals presenting with HLH in the setting of a lymphoma

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
    Actual Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Hemophagocytic lymphohistiocytosis (HLH) Patients

    Outcome Measures

    Primary Outcome Measures

    1. To determine the factors predicting 180 days overall survival of patients with cancer that are HLH-2004/OHI+ [The participant's survival would be assessed at 180 days from the malignancy diagnosis]

      The investigators will gather data on different treatments received, time to treatment, and other factors and determine which is associated with survival.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with lymphoma that are fulfilling at least one of the following:
    1. Meeting 5 of 8 HLH-2004 diagnostic criteria OR B. Are OHI index positive (sCD25>3,900 U/mL and ferritin>1,000 ng/mL)
    Exclusion Criteria:

    • Patients developing HLH> 1 month after lymphoma diagnosis (for aggressive lymphomas)

    • Patients with incomplete treatment and response documentation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: Gaurav Goyal, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gaurav Goyal, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT05898477
    Other Study ID Numbers:
    • IRB-300010383
    First Posted:
    Jun 12, 2023
    Last Update Posted:
    Jun 12, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphohistiocytosis, Hemophagocytic

    Study Results

    No Results Posted as of Jun 12, 2023