History of Changes for Study: NCT00991211

Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Latest version (submitted March 13, 2012) on ClinicalTrials.gov

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			October 6, 2009	None (earliest Version on record)
2			March 13, 2012	Sponsor/Collaborators and Study Status

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Study NCT00991211
Submitted Date: October 6, 2009 (v1)

Study Identification


Unique Protocol ID:	NHL 1-2003
Brief Title:	Bendamustine Plus Rituximab Versus CHOP Plus Rituximab
Official Title:	Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
Secondary IDs:

Study Status


Record Verification:	October 2009
Overall Status:	Completed
Study Start:	January 2004
Primary Completion:	August 2009 [Actual]
Study Completion:	August 2009 [Actual]

First Submitted:	October 6, 2009
First Submitted that Met QC Criteria:	October 6, 2009
First Posted:	October 7, 2009 [Estimate]

Last Update Submitted that Met QC Criteria:	October 6, 2009
Last Update Posted:	October 7, 2009 [Estimate]

Study Description

Brief Summary:

The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

Detailed Description:

The 4 agent chemotherapy (CTX) CHOP (cyclophosphamide, doxorubicin, vincristine prednisone) in combination with the monoclonal anti-CD20 antibody rituximab (CHOP-R) represents a standard CTX for the treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.

Conditions


Conditions:	Non-Hodgkin Lymphomas Follicular Lymphomas Immunocytomas Lymphocytic Lymphomas Marginal Zone Lymphomas
Keywords:	Comparison Bendamustine + Rituximab CHOP + Rituximab Progression free survival Overall survival Toxicity Safety

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	549 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Bendamustine + Rituximab Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w	Drug: Bendamustine Comparison of Bendamustine + Rituximab with CHOP + Rituximab Other Names: Ribomustin, Treanda
Active Comparator: CHOP + Rituximab Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w	Drug: Standard chemotherapy CHOP + Ritiximab Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy Other Names: Endoxan(R), Cyclostin(R) = Cyclophosphamide Adriamycin(R) Doxorubicin Oncovin(R) Vincristine Prednison Rituxan(R), MabThera(R) = Rituximab

Outcome Measures


Primary Outcome Measures:
1.	Progression free survival [ Time Frame: observation 3 years or significant differences between two arms ]
Secondary Outcome Measures:
1.	Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization [ Time Frame: ongoing ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities: Follicular lymphoma grade 1 and 2 Immunocytoma and lymphoplasmocytic lymphoma Marginal zone lymphoma, nodal and generalised Mantle cell lymphoma lymphocytic lymphoma (CLL without leucaemic characteristics) non-specified/classified lymphomas of low malignancy No prior therapy with cytotoxics,interferon or monoclonal antibodies Need for therapy, except mantle cell lymphomas Stadium III or IV Written informed consent Performance status WHO 0-2 Histology not older than 6 months Exclusion Criteria: Patients not establishing all above mentioned prerequisites Option of a primary, potential curative radiation therapy Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions Comorbidities excluding a study conform therapy: heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV), liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma.

Contacts/Locations


Study Officials:	Mathias Rummel, Dr. Principal Investigator Study Group of indolent Lymphom,as (StiL)
Locations:	Germany
	StiL Head Office; Justus-Liebig-University Giessen, Germany, 35392

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