- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04804865
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Katell LE DU, MD
Study Locations
-
-
-
Le Mans, France, 72000
- Recruiting
- Clinique Victor Hugo / Centre Jean Bernard
-
Principal Investigator:
- Katell LE DU, MD
-
Contact:
- Katell LE DÛ, MD
- Phone Number: 0033 0243391300
- Email: k.ledu@cjb72.org
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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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
population
The population includes adult patients.
|
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 Frame: 5 years
|
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 Frame: 5 years
|
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 Frame: 5 years
|
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
Time Frame: 6 month
|
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
Time Frame: 6 month
|
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
Investigators
- Study Director: Katell LE DU, MD, Weprom
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WP-2019-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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