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A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00472420
First received: May 10, 2007
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Mantle Cell Lymphoma
Drug: rituximab [MabThera/Rituxan]
Drug: First line chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR) [ Time Frame: Screening, Baseline (BL), every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment) ] [ Designated as safety issue: No ]
    CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) > 75% decrease in SPD of LNs > 1.5 cm, and > 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment) ] [ Designated as safety issue: No ]
    PFS was defined as the median time, in months, from the date of study entry to disease progression, death due to mantle cell lymphoma, or last contact. Progressive disease (PD) was defined by: a) 50% increase from nadir in the SPD of any previously identified abnormal LN, or b) appearance of any new lesion during or at the end of treatment. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.

  • Event Free Survival (EFS) [ Time Frame: Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment) ] [ Designated as safety issue: No ]
    EFS was defined as the median time, in months, from the date of study entry disease progression, relapse, secondary malignancy, death or last contact. Relapse was defined by: a) appearance of any new lesion or a ≥ 50% increase in size of previously involved sites, or b) ≥ 50% increase in GTD of any previously identified LN >1 cm in short axis or in the SPD of more than one LN. The 95% CI was estimated using Kaplan-Meier methodology.


Enrollment: 48
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 3 weeks
Drug: First line chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically-proven mantle cell lymphoma;
  • previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria:

  • known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
  • active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
  • serious disorders interfering with full standard dosing chemotherapy;
  • stage I disease.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472420

Locations
Hungary
Budapest, Hungary, 1122
Debrecen, Hungary, 4032
Gyor, Hungary, 9024
Kaposvar, Hungary, 7400
Miskolc, Hungary, 3529
Szeged, Hungary, 6720
Zalaegerszeg, Hungary, 8901
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00472420     History of Changes
Other Study ID Numbers: ML20493
Study First Received: May 10, 2007
Results First Received: November 21, 2014
Last Updated: November 21, 2014
Health Authority: Hungary: Ministry of Health

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on March 01, 2015