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

NCT03681938 | Unknown

• 1 other identifier: ALERT-IPC 2017-015
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, B-Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumulative Relapse Incidence

  From the date of complete remission post C2 of chemotherapy up to 120 months

• Overall survival

  From the date of complete remission post C2 of chemotherapy up to 120 months

Study Arms (2)

Intensification treatment: Autograft

Procedure: Autograft

Standard chemotherapy (without autograft)

Interventions

Autograft PROCEDURE

Autograft

Intensification treatment: Autograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients With High Risk Big B Cells Lymphoma

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13273, France

Location

Related Links

• Institut paoli-calmettes

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• BOUABDALLAH Réda, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: September 24, 2018
• Study Start: July 3, 2017
• Primary Completion: July 28, 2019
• Study Completion: July 28, 2019
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)