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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05898477 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : June 12, 2023 Last Update Posted : June 12, 2023 |
Sponsor:
Information provided by (Responsible Party):
Gaurav Goyal, University of Alabama at Birmingham
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.
| Lymphoma Hemophagocytic Lymphohistiocytoses |
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 Type : | Observational |
| Estimated 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 |
| Estimated Primary Completion Date : | January 2025 |
| Estimated Study Completion Date : | July 2025 |
| Hemophagocytic lymphohistiocytosis (HLH) Patients |
- To determine the factors predicting 180 days overall survival of patients with cancer that are HLH-2004/OHI+ [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: Â | Child, Adult, Older Adult |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Non-Probability Sample |
Patients with diagnosis of Hemophagocytic lymphohistiocytosis (HLH)
Inclusion Criteria:
- Patients with lymphoma that are fulfilling at least one of the following:
A. 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05898477
| Contact: Gaurav Goyal, MD | 205-934-1816 | ggoyal@uabmc.edu |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Gaurav Goyal, MD   205-934-6770   ggoyal@uabmc.edu   | |
University of Alabama at Birmingham
| Principal Investigator: | Gaurav Goyal, MD | University of Alabama at Birmingham |
| Responsible Party: | Gaurav Goyal, Principal Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT05898477 Â Â |
| Other Study ID Numbers: | IRB-300010383 |
| First Posted: | June 12, 2023 Â Â Key Record Dates |
| Last Update Posted: | June 12, 2023 |
| Last Verified: | June 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Histiocytosis, Non-Langerhans-Cell Histiocytosis |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
