Secondary Prognostic Index in RefrActory Lymphoma (SPiRAL)

Weprom

Status: Unknown

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

Treatments: Other: prognostic assessment

Study type: Observational

Funder types: Other

Identifiers

NCT04804865

WP-2019-02

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

population

Description:

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).

Treatment:

Other: prognostic assessment