Diffuse Large B Cell LymphomaSPiRALNCT04804865
Secondary Prognostic Index in RefrActory Lymphoma
An observational study of Diffuse Large B Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by Weprom at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
- What is being tested?
- prognostic assessment
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2020to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Katell LE DU, MD contact
France2 sites, 2 recruiting
- Recruiting
Clinique Victor Hugo / Centre Jean Bernard
Le Mans, 72000
Katell LE DÛ, MD, 0243391300 ext. 0033, k.ledu@cjb72.org
Katell LE DÛ, MD
- Not yet recruiting
Centre d'Oncologie de Gentilly
Nancy, 54000
Serge BOLOGNA, s.bologna@oncog.fr
Serge BOLOGNA, MD
About this study
Official title: 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.
- Being tested
- prognostic assessment
- Keywords
- prognostic score, cancer
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prognostic assessmentOther
determination of a prognostic score with 3 clinical and 5 biological parameters.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: prognostic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
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
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 6 month
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).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Jan 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katell LE DU, MD, Study director, Weprom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804865
- Sponsor's protocol ID
- WP-2019-02
- Acronym
- SPiRAL
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma
- ClinicalTrials.gov ID
- NCT04804865
- Acronym / sponsor ID
- SPiRAL / WP-2019-02
- Keywords
- prognostic score, cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- WepromUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| population | – | Other: prognostic assessmentThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prognostic assessmentdetermination of a prognostic score with 3 clinical and 5 biological parameters. | Other | population |
Primary outcome
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.
4 secondary outcomes
Median response time after each line
Time frame: 5 years
Event-free survival since diagnosis and after each line of treatment received
Time frame: 5 years
the intensity dose of chemotherapy received
Time frame: 6 month
the Cumulative Illness Rating Scale for comorbidities score in patients over 65 years old
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katell LE DU, MD contact
Katell LE DU, MD study director
Weprom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by Weprom at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali BALAVOINE (241682940 ext. +33, m.balavoine@weprom.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.