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Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas (073)

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

CEEP regimen

Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring High-dose chemotherapy, aggressive NHL, high-risk, PBSC

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients aged from 15 to 60 years
previously untreated
histologically proven aggressive NHL
high aa-IPI (equal to 3)
proper underlying organ function

Exclusion Criteria:

transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma

Sites / Locations

Emmanuel Gyan

Outcomes

Primary Outcome Measures

Complete response

Secondary Outcome Measures

overall survival disease free survival

Full Information

NCT ID

NCT00869284

First Posted

March 23, 2009

Last Updated

March 24, 2009

Sponsor

French Innovative Leukemia Organisation

Collaborators

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00869284

Brief Title

Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas

Acronym

073

Official Title

Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

October 1994 (undefined)

Primary Completion Date

July 1999 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

French Innovative Leukemia Organisation

Collaborators

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

Detailed Description

High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

High-dose chemotherapy, aggressive NHL, high-risk, PBSC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CEEP regimen

Intervention Description

cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals

Intervention Type

Procedure

Intervention Name(s)

Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)

Intervention Description

The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4. The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.

Primary Outcome Measure Information:

Title

Complete response

Time Frame

end of treatment

Secondary Outcome Measure Information:

Title

overall survival disease free survival

Time Frame

10 years after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients aged from 15 to 60 years previously untreated histologically proven aggressive NHL high aa-IPI (equal to 3) proper underlying organ function Exclusion Criteria: transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noël MILPIED, MDPD

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emmanuel Gyan

City

Tours

ZIP/Postal Code

37000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

21109011

Citation

Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, Francois S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.

Results Reference

derived

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Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas

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