NCT00558220

Brief Summary

The purpose of this study is to show if addition of Rituximab to intensive induction (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

Geographic Reach
1 country

8 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, 2002

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

February 12, 2007

Last Update Submit

November 10, 2007

Conditions

Diffuse Large B-Cell Lymphoma.Primary Mediastinal B-Cell LymphomaFollicular Lymphoma Grade III

Keywords

Lymphoma, B-cellImmunotherapy, passiveRemission inductionAutologous transplantation

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    3 years

Secondary Outcomes (2)

  • Complete remission and overall response rate

    One year

  • Overall survival

    3 years

Study Arms (1)

A

EXPERIMENTAL

Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy

Procedure: immunotherapyProcedure: Induction treatment part 1Procedure: Induction treatment part 2 with PBPC collectionProcedure: Induction treatment part 3Procedure: Consolidation treatment part 1: HD-chemotherapy with ASCTRadiation: Consolidation treatment part 2: Radiotherapy

Interventions

immunotherapyPROCEDURE

Given together with induction chemotherapy: Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses

A
Induction treatment part 1PROCEDURE

cyclophosphamide 3000 mg/m2 iv every 3 weeks, 3 cycles vincristin 2 mg iv every 3 weeks, 3 cycles doxorubicin 75 mg/m2 iv every 3 weeks, 3 cycles Prednisolone 300 mg/m2 divided into five days po every 3 weeks, 3 cycles pegfilgrastim 6 mg sc every 3 weeks. 3 cycles consisting of combination treatment of above mentioned drugs are given.

A
Induction treatment part 2 with PBPC collectionPROCEDURE

Starts three weeks after last cycle of Induction part 1. Etoposide 240 mg/m2 divided into equal doses for four days, together with methylprednisolone 2000 mg divided into equal doses for four days, together with cisplatin 100 mg/m2 divided into equal doses for four days, and together with cytarabine 2000 mg/m2 iv one dose on 4th day of treatment. Filgrastim 10-12 ug/kg from day five after start of chemotherapy untill stem cell collection. Peripheral blood progenitor cell collection (PBPC) is started when CD34 positive cells are \>20/cubic milimeter of blood and continued untill 5 million of CD34 positive cells are collected from peripheral blood.

A
Induction treatment part 3PROCEDURE

Part 3 of induction treatment is given approximately one week after the end of Part 2. Etoposide 240 mg/m2 divided into equal doses for four days, methylprednisolone 2000 mg divided into equal doses for four days, cisplatin 100 mg/m2 divided into equal doses for four days, cytarabine 2000 mg/m2 iv one dose on day 4 of chemotherapy and pegfilgrastim 6 mg on day five of chemotherapy are given twice three weeks apart.

A
Consolidation treatment part 1: HD-chemotherapy with ASCTPROCEDURE

Consolidation treatment Part 1 starts 4-8 weeks after the second cycle of Induction treatment Part 3. High dose chemotherapy (HD-chemotherapy) consists of: BCNU 300 mg/m2 is given on day 1, etoposide 800 mg/m2 divided into four equal doses is given on day 2-5, cytarabine 1600 mg/m2 divided into eight equal doses is given on day 2-5, melphalan 140 mg/m2 is given on day 6. On day 7, collected stem cells from peripheral blood (see Induction treatment part 1) are infused back to the patient. This is called autologous transplantation (ASCT). Filgrastim 5 ug/kg is given from day 14 (start of the chemotherapy being day 1) until neutrophil recovery.

A
Consolidation treatment part 2: RadiotherapyRADIATION

Radiotherapy is started given 4-8 weeks after the autologous transplantation. It is given to patients with initially bulky disease (\>10 cm at diagnosis) or to patients with residual disease after Induction treatment part 1-3 and Consolidation treatment part 1. 30-40 Gy are given in 2 Gy fractions over 3-4 weeks.

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma grade III
  • Age 18-65 years
  • Age-adjusted IPI score 2-3
  • ECOG performance status 0-3
  • Signed informed consent

You may not qualify if:

  • Burkitt lymphoma
  • Posttransplant lymphoproliferation
  • Previous treatment (up to one cycle of standard pretreatment with COP, CHOP or steroids permitted and latter mandatory to decrease tumor burden and/or improve performance status)
  • Other tumor in previous history with the exception of basalioma, squamous cell carcinoma of the skin or cervical carcinoma in situ
  • Pregnancy/lactation
  • CNS involvement
  • Other serious comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital Brno-Bohunice

Brno, 625 00, Czechia

Location

Hospital Chomutov

Chomutov, 430 12, Czechia

Location

Hospital České Budějovice

České Budějovice, Czechia

Location

University Hospital Hradec Králové

Hradec Králové, 500 05, Czechia

Location

University Hospital Královské Vinohrady

Prague, 100 34, Czechia

Location

General University Hospital

Prague, 128 08, Czechia

Location

University Hospital Motol

Prague, 150 00, Czechia

Location

Hospital Ústí nad Labem

Ústí nad Labem, 401 13, Czechia

Location

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, B-Cell

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Pytlik Robert, M.D.

    1st Department of Medicine, General University Hospital, Prague

    PRINCIPAL INVESTIGATOR

  • Marek Trněný, M.D., PhD.

    General University Hospital, Prague

    STUDY DIRECTOR

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

February 12, 2007

First Posted

November 14, 2007

Study Start

May 1, 2002

Study Completion

October 1, 2006

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

CZ(8)