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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lymphoma, B-Cell
• Intervention / Treatment: Procedure: Autograft

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13273
    • Institut Paoli-Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients With High Risk Big B Cells Lymphoma

Description

Inclusion Criteria:

• Patients with High Risk Big B Cells Lymphoma
• Age > 18 years

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intensification treatment: Autograft	Procedure: Autograft; Autograft
Standard chemotherapy (without autograft)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Relapse Incidence	Medical follow up	From the date of complete remission post C2 of chemotherapy up to 120 months
Overall survival	Medical follow up	From the date of complete remission post C2 of chemotherapy up to 120 months

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: BOUABDALLAH Réda, MD, Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Anticipated): July 28, 2019
• Study Completion (Anticipated): July 28, 2019

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: ALERT-IPC 2017-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO