We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153971
First Posted: June 30, 2010
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Drug: rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date [ Time Frame: Month 28 ]
    Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.


Secondary Outcome Measures:
  • Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase [ Time Frame: Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase) ]
    CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.

  • Percentage of Participants Achieving a Response by Response Type and Study Phase [ Time Frame: Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40 ]
    CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.

  • Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months.

  • FFS - Percentage of Participants With an Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date.

  • FFS - Time to Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

  • Overall Survival (OS) - Percentage of Participants Estimated to be Alive [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months.

  • OS - Percentage of Participants With an Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. ]
    OS was defined as the time from first dosage of study drug to the date of death from any cause.

  • OS - Time to Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. ]
    Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.

  • Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months.

  • DFS - Percentage of Participants With an Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. ]
    DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.

  • DFS - Time to Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. ]
    DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

  • Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months.

  • PFS - Percentage of Participants With an Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.

  • PFS - Time to Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

  • Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.

  • DR - Percentage of Participants With an Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.

  • DR - Time to Event [ Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 ]
    DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.


Enrollment: 47
Actual Study Start Date: July 20, 2005
Study Completion Date: September 24, 2010
Primary Completion Date: September 24, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab
1
Other Name: MabThera/Rituxan

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients 18-65 years of age;
  • previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
  • active disease;
  • >=3 involved sites.

Exclusion Criteria:

  • typical chronic lymphocytic leukemia;
  • other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
  • systemic corticosteroid use for >1 month;
  • significant cardiovascular disease;
  • central nervous system involvement;
  • hepatitis B or C virus infection, or HIV infection.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153971


Locations
Italy
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
Pescara, Abruzzo, Italy, 65100
Ospedale Civile; Divisione Di Oncologia
Pescara, Abruzzo, Italy, 65124
Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
Rionero in Vulture, Basilicata, Italy, 85028
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy, 89100
A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
Modena, Emilia-Romagna, Italy, 41100
Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
Reggio Emilia, Emilia-Romagna, Italy, 42100
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Roma, Lazio, Italy, 00161
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardia, Italy, 25123
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milano, Lombardia, Italy, 20122
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milano, Lombardia, Italy, 20162
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piemonte, Italy, 15121
Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
Cuneo, Piemonte, Italy, 12100
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Torino, Piemonte, Italy, 10126
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicilia, Italy, 98165
Az. Osp. Di Careggi; Divisione Di Ematologia
Firenze, Toscana, Italy, 50135
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01153971     History of Changes
Other Study ID Numbers: ML18324
First Submitted: June 14, 2010
First Posted: June 30, 2010
Results First Submitted: August 4, 2014
Results First Posted: August 21, 2014
Last Update Posted: August 1, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents