A randomised phase III study on the effect of the chimeric anti-CD20 monoclonal antibody (MabThera®) during sequential chemotherapy followed by autologous stem cell transplantation in patients with relapsed or progressive B-cell non-Hodgkin’s lymphoma

ISRCTN ISRCTN95614846
DOI https://doi.org/10.1186/ISRCTN95614846
ClinicalTrials.gov (NCT) NCT00012051
Protocol serial number NTR188; Ho44
Sponsor Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Funders Koningin Wilhelmina Fonds (KWF) (Netherlands), Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
28/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof E. Vellenga
Scientific

University Medical Center Groningen
Department of Hematology
P.O. Box 30001
Groningen
9700 RB
Netherlands

+31 (0)50 361 2354
e.vellenga@int.umcg.nl

Study information

Primary study designInterventional
Study designMulticentre randomised active controlled parallel group trial
Secondary study designRandomised controlled trial
Scientific titleRituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL: a prospective randomized HOVON trial.
Study acronymHOVON 44 NHL
Study objectivesEvaluation of the effect of MabThera® with respect to response to reinduction treatment before autologous stem cell transplantation and overall survival and event free survival after autologous stem cell transplantation.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedNon-Hodgkin's lymphoma (NHL)
InterventionPatients will be randomised to:

Arm A:
Cycle I: DHAP
Cycle II: VIM, in case of partial remission (PR) or complete remission (CR)
Cycle III: DHAP or VIM, BEAM + autologous SCT

Arm B:
Cycle I: DHAP + rituximab
Cycle II: VIM + rituximab, in case of PR or CR
Cycle III: DHAP or VIM + rituximab, BEAM + autologous SCT
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)MabThera®, rituximab; dexamethasone, cytarabine, cisplatin (DHAP); carmustine, etoposide, cytarabine, melphalan (BEAM); etoposide, ifosfamide, mitoxantrone, prednisone (VIM)
Primary outcome measure(s)

Overall survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive.

Key secondary outcome measure(s)

1. Response to DHAP-VIM with or without rituximab (MabThera®)
2. Event-free survival (i.e. time from registration to the date of stable disease after both the first and second reinduction cycle, documented progression, relapse or death, whichever comes first)

Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration300
Key inclusion criteria1. Malignant lymphoma based upon a representative histology specimen according to the REAL classification at relapse or progression:
1.1. Follicular center lymphoma, follicular (grade III)
1.2. Diffuse large B-cell lymphoma
1.3. Primary mediastinal B-cell lymphoma
2. CD20 positive
3. First progression or relapse during/after adriamycin containing regimen. 'Progressive' includes patients who have progressive disease (PD, without prior response) and patients who have progression after first PR
4. Aged 18 - 65 years inclusive
5. World Health Organization (WHO) performance status 0 - 1
6. Witnessed written informed consent according to the center requirements
Key exclusion criteria1. Patients with history of intolerance of exogenous protein administration
2. Patients with severe cardiac dysfunction (New York Heart Association [NYHA] classification II - IV)
3. Patients with severe pulmonary dysfunction (vital capacity or diffusion capacity less than 70% of predicted value) unless clearly related to non-Hodgkins Lymphoma (NHL) involvement
4. Patients with hepatic dysfunction, bilirubin or transaminase greater than or equal to 25 x upper normal limit
5. Patients with renal dysfunction (serum creatinine greater than or equal to 180 mmol/l or clearance less than or equal to 40 ml/min)
6. Prior treatment with immunotherapy or radiation therapy within the last month before entering the study
7. Patients with active uncontrolled infections
8. Patients known to be human immunodeficiency virus (HIV)-positive
9. Patients with NHL localisation in the central nervous system
10. Patients with (EBV) post-transplant lymphoproliferative disorder
Date of first enrolment20/11/2000
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/01/2008 28/01/2019 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

28/01/2019: Publication reference added

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