The Value and Mechanisms for Monocytes Subpopulations in Predicting the Prognosis of Lymphomas

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

The Value and Potential Mechanisms for Monocytes Subpopulations in Predicting the Prognosis of Non-Hodgkin Lymphomas.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03000738
• Other study ID #: PUMCH-1163
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: March 30, 2017
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2017
• Source: Peking Union Medical College Hospital
• Contact: Wei Zhang
• Phone: +86-010-69151235
• Email: vv1223[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio could help predict the prognosis of DLBCL and PTCL.

Description:

The investigators plan to prospectively involve 100 non-hodgekin lymphoma patients, including 50 diffuse large B cell lymphomas and 50 peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital.

The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review.

All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by enhanced computed tomography or PET-CT.

The peripheral blood would be collected. The Cytodiff flow cytometric technique would be used to test 16 leukocyte subpopulations from peripheral blood at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression.

Progression-free survival (PFS) and overall survival (OS) would be estimated using the Kaplan-Meier method and two-tailed log-rank test.The Cox proportional hazards model would evaluate prognostic factors for OS and PFS. Specificity, sensitivity and cut-off would be established using time-dependent receiver operating characteristic (ROC) curve analysis. Area under curve (AUC) values >0.7 indicate that the parameter can be used for diagnosis, with values >0.9 indicating high clinical accuracy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL, DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL, HSTL)

2. no treatment before

3. hCG(-)

4. 18 years old to 80 years old

Exclusion Criteria:

1. other tumors

2. severe infections

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Lymphoma,Non-Hodgkin
• Peripheral T-Cell Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

References & Publications (4)

Heagerty PJ, Lumley T, Pepe MS. Time-dependent ROC curves for censored survival data and a diagnostic marker. Biometrics. 2000 Jun;56(2):337-44. — View Citation

Subimerb C, Pinlaor S, Lulitanond V, Khuntikeo N, Okada S, McGrath MS, Wongkham S. Circulating CD14(+) CD16(+) monocyte levels predict tissue invasive character of cholangiocarcinoma. Clin Exp Immunol. 2010 Sep;161(3):471-9. doi: 10.1111/j.1365-2249.2010.04200.x. — View Citation

Wilcox RA, Ristow K, Habermann TM, Inwards DJ, Micallef IN, Johnston PB, Colgan JP, Nowakowski GS, Ansell SM, Witzig TE, Markovic SN, Porrata L. The absolute monocyte and lymphocyte prognostic score predicts survival and identifies high-risk patients in diffuse large-B-cell lymphoma. Leukemia. 2011 Sep;25(9):1502-9. doi: 10.1038/leu.2011.112. — View Citation

Ziegler-Heitbrock L, Ancuta P, Crowe S, Dalod M, Grau V, Hart DN, Leenen PJ, Liu YJ, MacPherson G, Randolph GJ, Scherberich J, Schmitz J, Shortman K, Sozzani S, Strobl H, Zembala M, Austyn JM, Lutz MB. Nomenclature of monocytes and dendritic cells in blood. Blood. 2010 Oct 21;116(16):e74-80. doi: 10.1182/blood-2010-02-258558. Epub 2010 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years
Secondary	progression free survival		3 years