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Hodgkin LymphomaNCT04893538

Prognostic Value Of Lymphocyte Count and Lymphocyte/ Monocyte Ratio in Patients With Hodgkin's Lymphoma

An observational study of Hodgkin Lymphoma, run by Latakia University at 1 site in Syria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is to assess the utility of using Absolute Lymphocyte count, Lymphocyte/Monocyte Ratio and International Prognostic Scote at diagnosis in Hodgkin's Lymphoma as a prognostic predictor of therapeutic response, overall survival and progression free survival Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9 and First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9
Type of treatment
Injection or infusion
How many people
100 participants
Where
1 siteSyria
Study dates
4 Jan 2021to 1 Jul 2022
How long will I take part?
18 Months
Phase
Observational
Are there results?
None posted in the registry

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 15 years and older
  • All sexes
  • Child, Adult, Older adult

Study population: Patients newly diagnosed with Hodgkin's lymphoma at the Oncology Center of Tishreen University Hospital who have not yet received treatment

Who may be able to join

  • Newly diagnosed patients with Hodgkin's Lymphoma who have not yet received treatment
  • Ages over 16 years old
  • Signed informed consent before registration in study

Who cannot join

  • Patients who have already received treatment
  • Patients with a previous history of malignancy
  • Patients with autoimmune diseases
  • Patients with primary immunodeficiency
  • AIDS patients
  • Patients with acute or chronic infections
  • Patients treated with drugs that affect the result of the analysis (Corticosteroids, Immunosuppressants, Li)

Trial locations and contacts

1 site in 1 country.

Hasan Khalil, Dr. contact

00963992869604

hsnkhal@gmail.com

Syria1 site, 1 recruiting

  • Tishreen University

    Latakia

    Hassan Khalil, Dr., 00963992869604, hsnkhal@gmail.com

    Recruiting

Other trials in Syria

About this study

This study is to assess the utility of using Absolute Lymphocyte count, Lymphocyte/Monocyte Ratio and International Prognostic Scote at diagnosis in Hodgkin's Lymphoma as a prognostic predictor of therapeutic response, overall survival and progression free survival

Read the detailed description

Hodgkin's Lymphoma has a high cure rate even if patients do not complete their treatment, this proposes that some patients may experience overtreatment and that would have negative effects (such as cardiac toxicity, sterility, secondary malignancies...) which makes it imperative to search for prognostic predictor suitable for all stages of disease, knowing that the International Prognostic Score "IPS" is restricted to advanced stages of the disease.

Absolute Lymphocyte count reflects the immune status of the individuals. It has been shown that an individual's immune status controls the extent of his response treatment, overall survival and his progression free survival because of the role that Lymphocytes play in suppressing and eliminating tumor cells.

Tumor-Associated Macrophages "TAMs" have been shown to play a role in tumor growth and development. Also, it has been shown that an increase in peripheral Monocyte count is associated with an increase in TAMs, so that the Monocyte count may constitute an important prognostic predictor.

Combining the Lymphocyte count and the Monocyte count into one index may be better for estimating the prognosis.

The aim of this study is to determine the prognostic significance of Absolute Lymphocyte count "ALC", Lymphocyte/Monocyte Ratio "LMR" and International Prognostic Score "IPS" at the cut-off points: 1500 cells per microliter for ALC, 2.9 for LMR and Score=3 for IPS.

Investigators get these cut-off points by conducting a retrospective case-control study on previous patients in Oncology Center, Tishreen Hospital, Syria in 2020.

This study will be prospective cohort :

  1. participants will be divided into two subgroups (patients have ALC >= 1500 cells per microliter and who have ALC < 1500 cells per microliter). Those two subgroups will be homogenized in terms of other prognostic factors using Propensity Score.
  2. the same participants will be also divided into another two subgroups (who have IPS < 3 and who have IPS >=3) and Those two subgroups will be homogenized using Propensity Score.
  3. Finally the same participants will be divided into two subgroups (who have LMR >= 2.9 and who have LMR < 2.9) and Those two subgroups will be homogenized as mentioned before.

Then Investigators will monitor the therapeutic response, overall survival and progression free survival for 18 months for each subgroup and compare these indexes to determine the effectiveness of each of them in each stage of the disease

Being tested
First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9, First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9
Keywords
Lymphocyte count, International Prognostic Score, Lymphocyte/monocyte Ratio, Prognosis
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9Diagnostic test

    Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio and for plasma Albumin to obtain IPS

  • First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9Diagnostic test

    Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio and for plasma Albumin to obtain IPS

Study groups in NCT04893538
Study groupRoleWhat they receive
AFirst analysis: Patients with high Lymphocyte count Second analysis: Patients with low International Prognosis Score Third analysis: Patients with high Lymphocyte/monocyte ratio
Receives: Diagnostic Test: First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9
BFirst analysis: Patients with low Lymphocyte count Second analysis: Patients with high International Prognostic Score Third analysis: Patients with low Lymphocyte/monocyte ratio
Receives: Diagnostic Test: First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic response

    Achieve complete remission after completing the prescribed treatment plan

    Measured: 6 months

  2. overall survival

    The occurrence of death after acceptance to study

    Measured: 18 months

  3. progression free survival

    The occurrence of relapse after acceptance to study

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start4 Jan 2021
  3. Primary completion21 Jun 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

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
100 participants (estimated)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893538
Sponsor's protocol ID
Lymphopenia and Hodgkin
Status last verified
Feb 2022
First submitted
6 May 2021
Last updated
3 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Hancock BW, Dunsmore IR, Swan HT. Lymphopenia: a bad prognostic factor in Hodgkin's disease. Scand J Haematol. 1982 Sep;29(3):193-9.

    PubMed 7146822

  • Hasenclever D, Diehl V. A prognostic score for advanced Hodgkin's disease. International Prognostic Factors Project on Advanced Hodgkin's Disease. N Engl J Med. 1998 Nov 19;339(21):1506-14. doi: 10.1056/NEJM199811193392104.

    PubMed 9819449

  • Ayoub JP, Palmer JL, Huh Y, Cabanillas F, Younes A. Therapeutic and prognostic implications of peripheral blood lymphopenia in patients with Hodgkin's disease. Leuk Lymphoma. 1999 Aug;34(5-6):519-27. doi: 10.3109/10428199909058479.

    PubMed 10492075

  • Porrata LF, Ristow K, Colgan JP, Habermann TM, Witzig TE, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Nowakowski GS, Thompson C, Markovic SN. Peripheral blood lymphocyte/monocyte ratio at diagnosis and survival in classical Hodgkin's lymphoma. Haematologica. 2012 Feb;97(2):262-9. doi: 10.3324/haematol.2011.050138. Epub 2011 Oct 11.

    PubMed 21993683

  • Koh YW, Kang HJ, Park C, Yoon DH, Kim S, Suh C, Go H, Kim JE, Kim CW, Huh J. The ratio of the absolute lymphocyte count to the absolute monocyte count is associated with prognosis in Hodgkin's lymphoma: correlation with tumor-associated macrophages. Oncologist. 2012;17(6):871-80. doi: 10.1634/theoncologist.2012-0034. Epub 2012 May 15.

    PubMed 22588324

  • Tadmor T, Polliack A. Lymphopenia a simple prognostic factor in lymphoma and other cancers: why not use it more as a guide? Leuk Lymphoma. 2010 Oct;51(10):1773-4. doi: 10.3109/10428194.2010.508825. No abstract available.

    PubMed 20849382

Questions about this trial

What is this clinical trial studying?

An observational study of Hodgkin Lymphoma, run by Latakia University at 1 site in Syria.

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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Mar 2022. 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 Syria. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hasan Khalil, Dr. (00963992869604, hsnkhal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic response (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04893538, which also lists 6 linked publications.

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 3 Mar 2022.

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