Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission?

Lymphoma, B-Cell Clinical Trial

Official title:

Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission After 2 Cycles of Chemotherapy ?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03681938
• Other study ID #: ALERT-IPC 2017-015
• Status: Active, not recruiting
• Start date: July 3, 2017
• Est. completion date: July 28, 2019

Study information

• Verified date: September 2018
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The autograft of patients with prognostically unfavourable B-cells lymphoma cells in first remission remains controversial, in particular since the association of Rituximab with chemotherapy. Even though many randomized and non-randomized studies have been conducted, their is still no standard procedure . Recently, the use of early TEP (positron emission topography) answer, after 2 in 3 cures of chemotherapy allowed to select the poor-responder patients who remain candidate to autograft in front-line. Nevertheless, in good-responder patients, the benefits of an intensification therapy ins term of long-lasting disease control remains discussion.

This institutional retrospective study aims at comparing the outcome of early metabolic responder patients who received an intensification treatment to those who received a standard chemotherapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 183
• Est. completion date: July 28, 2019
• Est. primary completion date: July 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with High Risk Big B Cells Lymphoma

• Age > 18 years

Exclusion Criteria:

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

Procedure:
• Autograft
Autograft

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the survival without progress of transplanted patients versus not transplanted patients	Medical follow up	From the date of complete remission post C2 of chemotherapy up to 120 months
Secondary	Cumulative Relapse Incidence	Medical follow up	From the date of complete remission post C2 of chemotherapy up to 120 months
Secondary	Overall survival	Medical follow up	From the date of complete remission post C2 of chemotherapy up to 120 months

External Links

•   Institut paoli-calmettes