Secondary Prognostic Index in RefrActory Lymphoma

NCT ID: NCT04804865

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

prognostic assessment

Intervention Type OTHER

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

Interventions

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prognostic assessment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weprom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katell LE DU, MD

Role: STUDY_DIRECTOR

Weprom

Locations

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Clinique Victor Hugo / Centre Jean Bernard

Le Mans, , France

Site Status RECRUITING

Centre d'Oncologie de Gentilly

Nancy, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Magali BALAVOINE

Role: CONTACT

241682940 ext. +33

Katell LE DU, MD

Role: CONTACT

Facility Contacts

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Katell LE DÛ, MD

Role: primary

0243391300 ext. 0033

Serge BOLOGNA

Role: primary

Other Identifiers

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WP-2019-02

Identifier Type: -

Identifier Source: org_study_id

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