Secondary Prognostic Index in RefrActory Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

— SPiRAL  

Official title:

Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04804865
• Other study ID #: WP-2019-02
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2021
• Source: Weprom
• Contact: Magali BALAVOINE
• Phone: 241682940
• Email: m.balavoine[@]weprom.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• prognostic assessment
determination of a prognostic score with 3 clinical and 5 biological parameters.

Locations

Country	Name	City	State
France	Clinique Victor Hugo / Centre Jean Bernard	Le Mans
France	Centre d'Oncologie de Gentilly	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Weprom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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