NCT00169143

Brief Summary

Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2004

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

September 12, 2005

Last Update Submit

August 21, 2018

Conditions

Untreated CD20-positive Large B-cell Lymphoma

Keywords

Diffuse large B cell lymphomaPegfilgrastimAutotransplant

Outcome Measures

Primary Outcomes (1)

  • To evaluate the optimal combined dose intensity of the drug regimen

Secondary Outcomes (1)

  • Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival

Interventions

Rituximab + ACVBP regimen plus PegfilgrastimDRUG
Autologous stem cell transplantPROCEDURE

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
  • Age \>18 and \< 61 years, eligible for transplant.
  • Patient not previously treated.
  • With at least two prognostic factors of the Aa-IPI.
  • With a minimum life expectancy of 3 months.
  • Creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma.
  • Neutrophils \> 1.5 G/l and platelets \> 100 G/l, unless if patient has a bone marrow infiltration.
  • Negative HIV, HBV and HCV serologies 4 weeks (except after vaccination).
  • Having previously signed a written informed consent.

You may not qualify if:

  • Any other histological type of lymphoma.
  • Any history of treated or non-treated indolent lymphoma.
  • Central nervous system or meningeal involvement by lymphoma.
  • Contra-indication to any drug contained in the chemotherapy regimens.
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Any serious active disease (according to the investigator's decision).
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
  • Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception.
  • Adult patient under tutelage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Henri Mondor

Créteil, France

Location

Service d'Hématologie Clinique - CHU Le Bocage

Dijon, France

Location

Hôpital Saint Louis

Paris, France

Location

Service d'Hématologie - Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Location

Centre Henri Becquerel

Rouen, France

Location

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, France

Location

Related Publications (5)

  • Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35. doi: 10.1093/annonc/mdg019.

    PMID: 12488289BACKGROUND

  • Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.

    PMID: 11821454BACKGROUND

  • Vose JM, Crump M, Lazarus H, Emmanouilides C, Schenkein D, Moore J, Frankel S, Flinn I, Lovelace W, Hackett J, Liang BC. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol. 2003 Feb 1;21(3):514-9. doi: 10.1200/JCO.2003.03.040.

    PMID: 12560443BACKGROUND

  • Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.

    PMID: 10944137BACKGROUND

  • Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

    PMID: 26373676DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

RituximabLNH 87 protocolpegfilgrastim

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Corinne Haioun, MD

    Hôpital Henri Mondor, Créteil, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

May 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

FR(6)