LymphomaNCT05898477
Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
An observational study of Lymphoma and Hemophagocytic Lymphohistiocytoses, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Hemophagocytic Lymphohistiocytoses
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diagnosis of Hemophagocytic lymphohistiocytosis (HLH)
Who may be able to join
- Patients with lymphoma that are fulfilling at least one of the following:
- 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)
Who cannot join
- Patients developing HLH> 1 month after lymphoma diagnosis (for aggressive lymphomas)
- Patients with incomplete treatment and response documentation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Gaurav Goyal, MD, 2059346770, ggoyal@uabmc.edu
About this study
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.
Read the 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
- Conditions
- Lymphoma, Hemophagocytic Lymphohistiocytoses
- Medical subject headings
- Lymphoma, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemophagocytic lymphohistiocytosis (HLH) Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the factors predicting 180 days overall survival of patients with cancer that are HLH-2004/OHI+
The investigators will gather data on different treatments received, time to treatment, and other factors and determine which is associated with survival.
Measured: The participant's survival would be assessed at 180 days from the malignancy diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 May 2023
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Goyal, University of Alabama at Birmingham
- Investigators
- Gaurav Goyal, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898477
- Sponsor's protocol ID
- IRB-300010383
- Status last verified
- Jan 2026
- First submitted
- 1 Jun 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
- ClinicalTrials.gov ID
- NCT05898477
- Acronym / sponsor ID
- IRB-300010383
- Conditions
- Lymphoma, Hemophagocytic Lymphohistiocytoses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophagocytic lymphohistiocytosis (HLH) Patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosis of Hemophagocytic lymphohistiocytosis (HLH)
Key inclusion criteria (2 listed)
- Patients with lymphoma that are fulfilling at least one of the following:
- 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)
Key exclusion criteria (2 listed)
- Patients developing HLH> 1 month after lymphoma diagnosis (for aggressive lymphomas)
- Patients with incomplete treatment and response documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaurav Goyal, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Hemophagocytic Lymphohistiocytoses, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaurav Goyal, MD (205-934-1816, ggoyal@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.