Secondary Prognostic Index in RefrActory Lymphoma

NCT04804865 | Unknown

• 1 other identifier: WP-2019-02
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

60% of patients with diffuse large B cell lymphoma are healed after first-line treatment which whatever the age. For the remaining 40% of patients (relapses and primary refractories):

• 38% of patients will be cured with a 2nd line including an autologous haematopoietic cell transplantation for those under 65 years.
• for older patients who are not eligible for a autograft: only 70% of patients will be able to receive 2nd line treatment with rates response less than 50%.
• the survival rate in patients receiving 3rd line treatment or more is 15% at 2 years. Actually, no standard of chemotherapy is offered to relapsed or refractory patients after 2 therapeutic lines. Subsequent lines lead to hospitalizations for infectious complications or transfusions without clear clinical benefit with often an impacted quality of life. Palliative care is rarely offered as part of the treatment overall load.

Conditions

Diffuse Large B Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma

Keywords

prognostic score; cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time between the date of relapse or no response observed (after 2 lines of chemotherapy in young patients and one line for elderly patients) and the date of death regardless of the cause.

  5 years

Secondary Outcomes (4)

• Median response time after each line

  5 years

• Event-free survival since diagnosis and after each line of treatment received

  5 years

• the intensity dose of chemotherapy received

  6 month

• the Cumulative Illness Rating Scale for comorbidities score in patients over 65 years old

  6 month

Study Arms (1)

population

The population includes adult patients. * Patients died from refractory or relapsed diffuse large-cell lymphoma. * Patients \<65 years of age eligible for an autologous transplant should have relapsed after the autologous transplant. * Patients \>65 years of age or not eligible after an autologous transplant must have received at least one RCHOP-type treatment line (2 cycles).

Other: prognostic assessment

Interventions

prognostic assessment OTHER

determination of a prognostic score with 3 clinical and 5 biological parameters.

population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population includes adult patients, who have died with refractory or relapsed diffuse large-cell lymphoma. Patients \<65 years of age eligible for an autologous transplant should have relapsed after the autologous transplant. Patients\> 65 years of age or not eligible after an autologous transplant must have received at least one RCHOP-type treatment line (2 cycles).

You may qualify if:

• Age \> 18 years old
• died of diffuse large B cell lymphoma
• Refractory or relapsing after 2 treatment lines for young patients (RCHOP then recovery with platinum salts and autograft) and one line for elderly patients (RCHOP)

You may not qualify if:

• patients with HIV infection
• solid tumor treated less than 5 years ago with the exception of skin carcinoma or carcinoma in situ of the uterine cervix treated locally

Sponsors & Collaborators

• Weprom: lead

Study Sites (2)

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, 72000, France

RECRUITING

Centre d'Oncologie de Gentilly

Nancy, 54000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Katell LE DU, MD

  Weprom

  STUDY DIRECTOR

Central Study Contacts

Magali BALAVOINE

CONTACT

241682940; m.balavoine@weprom.fr

Katell LE DU, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: January 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)