Secondary Prognostic Index in RefrActory Lymphoma (SPiRAL)

Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Other: prognostic assessment

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Katell Le Dû, MD

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • Clinique Victor Hugo / Centre Jean Bernard
    • Principal Investigator: Katell Le Dû, MD
    • Contact: Katell LE DÛ, MD; Phone Number: 0033 0243391300; Email: k.ledu@cjb72.org
  • Nancy, France, 54000
    • Not yet recruiting
    • Centre d'oncologie de Gentilly
    • Contact: Serge BOLOGNA; Email: s.bologna@oncog.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• inclusion in a therapeutic trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; determination of a prognostic score with 3 clinical and 5 biological parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median response time after each line	Time between the date when the first response criterion is observed (partial or complete response) and the date when the recurrence or progression is objectively documented	5 years
Event-free survival since diagnosis and after each line of treatment received	Time between the date of diagnosis and the date of the first event observed, then between the date of the first administration of each line of treatment administered and the date of onset of the first event observed.	5 years
the intensity dose of chemotherapy received	Total amount of chemotherapy administered relative to the theoretical dose calculated according to the patient's body surface area.	6 month
the Cumulative Illness Rating Scale for comorbidities score in patients over 65 years old	The cumulative illness rating scale for comorbidity score in elderly patients will be calculated according to the table proposed by Salvi et al. in 2008 (values :0 to 56; higher scores mean a worse outcome).	6 month

Collaborators and Investigators

• Sponsor: Weprom
• Investigators: Study Director: Katell LE DU, MD, Weprom

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: cancer; prognostic score
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: WP-2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No