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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893538
• Other study ID #: Lymphopenia and Hodgkin
• Status: Recruiting
• Start date: January 4, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2022
• Source: Tishreen University
• Contact: Hasan Khalil, Dr.
• Phone: 00963992869604
• Email: hsnkhal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2022
• Est. primary completion date: June 21, 2022
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen University	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic response	Achieve complete remission after completing the prescribed treatment plan	6 months
Primary	overall survival	The occurrence of death after acceptance to study	18 months
Primary	progression free survival	The occurrence of relapse after acceptance to study	18 months