HLHHLHNCT05882175
Prospective Validation of the OHI Index
An observational study of HLH and Hemophagocytic Lymphohistiocytoses, run by Meir Medical Center at 2 sites in Israel.
Trial summary
Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HLH, Hemophagocytic Lymphohistiocytoses, Hemophagocytic Syndrome
- How many people
- 300 participants
- Where
- 2 sitesIsrael
- Study dates
- 3 Mar 2021to 3 Mar 2030
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and females with new diagnosis/transformation/reactivation of hematologic malignancies
Who may be able to join
- Patients with hematologic malignancies
- At least 18 years old
Who cannot join
- Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
Uri Abadi, MD, +972 537482629, uri.abadi@clalit.org.il
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Ronit Gurion, MD, +972 504065336, ronitg@clalit.org.il
About this study
Official title: A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index
Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) > 3,900 U/mL and ferritin >1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.
Read the detailed description
The investigators will enroll patients with new/transformed hematologic malignancies. The investigators will follow the patients until the end of the study, report their survival at one year and examine their prognosis.
- Conditions
- HLH, Hemophagocytic Lymphohistiocytoses, Hemophagocytic Syndrome, Hematologic Malignancy, Hematologic Neoplasms
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic, Hematologic Neoplasms
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 |
|---|---|---|
| OHI+ patients | Adult patients with hematologic malignancies that have sCD25>3,900 U/mL and ferritin >1,000 ng/mL | |
| OHI- patients | Adult patients with hematologic malignancies, with sCD25>3,900 U/mL and/or ferritin < 1,000 ng/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess 365 days mortality of OHI+ and OHI- patients
The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients
Measured: Mortality rate one year from OHI assessment
Secondary outcomes (1)
To determine the incidence of OHI+ patients in our cohort
The investigators will assess the incidence of OHI+ within our cohort (OHI+/total patients enrolled)
Measured: The investigators will assess the incidence after three years of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start3 Mar 2021
- Primary completion3 Mar 2030 (estimated)
- Study completion3 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HLHStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Rabin Medical Center, Sheba Medical Center, Schneider Children's Medical Center, Israel
- Responsible party
- Sponsor
- Investigators
- Adi Zoref-Lorenz, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882175
- Sponsor's protocol ID
- 0321-19-MMC
- Acronym
- HLH
- Status last verified
- May 2025
- First submitted
- 19 Jan 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zoref-Lorenz A, Murakami J, Hofstetter L, Iyer S, Alotaibi AS, Mohamed SF, Miller PG, Guber E, Weinstein S, Yacobovich J, Nikiforow S, Ebert BL, Lane A, Pasvolsky O, Raanani P, Nagler A, Berliner N, Daver N, Ellis M, Jordan MB. An improved index for diagnosis and mortality prediction in malignancy-associated hemophagocytic lymphohistiocytosis. Blood. 2022 Feb 17;139(7):1098-1110. doi: 10.1182/blood.2021012764.
PubMed 34780598
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index
- ClinicalTrials.gov ID
- NCT05882175
- Acronym / sponsor ID
- HLH / 0321-19-MMC
- Conditions
- HLH, Hemophagocytic Lymphohistiocytoses, Hemophagocytic Syndrome, Hematologic Malignancy, Hematologic Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Rabin Medical Center, Sheba Medical Center, Schneider Children's Medical Center, Israel
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 3 Mar 2030 (estimated)
- Study completion
- 3 Mar 2030 (estimated)
- First posted
- 31 May 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.
Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) > 3,900 U/mL and ferritin >1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.
Detailed description
The investigators will enroll patients with new/transformed hematologic malignancies. The investigators will follow the patients until the end of the study, report their survival at one year and examine their prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OHI+ patients | – | –Adult patients with hematologic malignancies that have sCD25>3,900 U/mL and ferritin >1,000 ng/mL |
| OHI- patients | – | –Adult patients with hematologic malignancies, with sCD25>3,900 U/mL and/or ferritin < 1,000 ng/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and females with new diagnosis/transformation/reactivation of hematologic malignancies
Key inclusion criteria (2 listed)
- Patients with hematologic malignancies
- At least 18 years old
Key exclusion criteria (1 listed)
- Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)
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 assess 365 days mortality of OHI+ and OHI- patients
Time frame: Mortality rate one year from OHI assessment
The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients
1 secondary outcome
To determine the incidence of OHI+ patients in our cohort
Time frame: The investigators will assess the incidence after three years of enrollment
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 13 May 2025.
- Background: PubMed 34780598Zoref-Lorenz A, Murakami J, Hofstetter L, Iyer S, Alotaibi AS, Mohamed SF, Miller PG, Guber E, Weinstein S, Yacobovich J, Nikiforow S, Ebert BL, Lane A, Pasvolsky O, Raanani P, Nagler A, Berliner N, Daver N, Ellis M, Jordan MB. An improved index for diagnosis and mortality prediction in malignancy-associated hemophagocytic lymphohistiocytosis. Blood. 2022 Feb 17;139(7):1098-1110. doi: 10.1182/blood.2021012764.
- Individual participant dataSharing planned: No
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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.
Adi Zoref-Lorenz principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HLH and Hemophagocytic Lymphohistiocytoses, run by Meir Medical Center at 2 sites in Israel.
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 1 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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 Adi Zoref Lorenz, MD (513 6525610, adi.zoref.lorenz@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess 365 days mortality of OHI+ and OHI- patients (time frame: Mortality rate one year from OHI assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882175, which also lists 1 linked publication.
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 13 May 2025.