Overview

This trial is active, not recruiting.

Condition lymphoma, non hodgkin
Treatment rituximab [mabthera/rituxan]
Phase phase 3
Target CD20
Sponsor Hoffmann-La Roche
Start date November 2013
End date May 2017
Trial size 140 participants
Trial identifier NCT01987505, ML28943

Summary

This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of MabThera/Rituxan during first-line treatment for patients with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of MabThera/Rituxan IV. Patients with FL will be given 1400 mg MabThera/Rituxan SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of MabThera/Rituxan will be given to patients with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for patients with DLBCL and up to 32 months for patients with FL.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rituximab [mabthera/rituxan]
1400 mg injected subcutaneously (SC)

Primary Outcomes

Measure
Incidence of administration-associated reactions (AARs)
time frame: Up to 32 months

Secondary Outcomes

Measure
Grade >/= 3 Adverse events (AEs)
time frame: Up to 32 months
Serious AEs
time frame: Up to 32 months
Event-free survival, defined as the time from the first dose of MabThera/Rituxan IV until disease progression or relapse, initiation of new therapy or death.
time frame: Up to 32 months
Overall survival defined as the time from the first dose of MabThera/Rituxan until death
time frame: Up to 32 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria

  • Age >/= 18 and </= 80 years at time of enrolment.
  • Life expectancy >/= 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 3.
  • Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant.
  • Histologically confirmed CD20+ DLBCL or CD20+ follicular NHL (FL) grade 1, 2 or 3a according to the WHO classification system. Induction only:
  • Patients with FL should meet Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria to initiate treatment.
  • At least tumor >/= 1.5 cm as measured by computed tomography (CT) scan. FL treatment-related criteria
  • Currently being treated with MabThera/Rituxan IV during first-line therapy and has received at least one full dose of MabThera/Rituxan IV.

Exclusion Criteria

  • Transformed lymphoma.
  • Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma.
  • History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for >/= 5 years prior to dosing. Note: Patients with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study.
  • Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: patients receiving corticosteroid treatment with </= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing.
  • Inadequate renal, hematologic, or hepatic function.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
  • For patients with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
  • For patients with FL: contraindication to standard chemotherapy.
  • Other serious underlying medical conditions.
  • Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.
  • Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Note: Patients testing positive for hepatitis B or C virus antibodies but with an undetectable viral load may be included.
  • History of human immunodeficiency virus (HIV) positive status.

Additional Information

Official title OPEN LABEL, SINGLE-ARM, PHASE IIIb CLINICAL TRIAL TO EVALUATE THE SAFETY OF SWITCHING FROM INTRAVENOUS RITUXIMAB TO SUBCUTANEOUS RITUXIMAB DURING FIRST LINE TREATMENT FOR CD20+ NON-HODGKIN'S FOLLICULAR LYMPHOMA AND DIFFUSE LARGE B-CELL LYMPHOMA.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.