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Secondary Prognostic Index in RefrActory Lymphoma

Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04804865
Acronym
SPiRAL
Enrollment
180
Registered
2021-03-18
Start date
2020-01-01
Completion date
2022-06-01
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

prognostic score, cancer

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.

Interventions

OTHERprognostic assessment

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

Sponsors

Weprom
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival5 yearsTime 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.

Secondary

MeasureTime frameDescription
Median response time after each line5 yearsTime 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
Event-free survival since diagnosis and after each line of treatment received5 yearsTime 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.
the intensity dose of chemotherapy received6 monthTotal amount of chemotherapy administered relative to the theoretical dose calculated according to the patient's body surface area.
the Cumulative Illness Rating Scale for comorbidities score in patients over 65 years old6 monthThe 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).

Countries

France

Contacts

Primary ContactMagali BALAVOINE
m.balavoine@weprom.fr241682940
Backup ContactKatell LE DU, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026