Phase 3
Completed N=572
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
Lymphoma, Large B-Cell, Diffuse
Source: ClinicalTrials.gov NCT01649856 ↗
Enrolled (actual)
572
Serious AEs
40.6%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) — 50.6; 42.4 percentage of participants — p=0.076
Summary
This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) |
50.6; 42.4 | 0.076 |
| SECONDARY Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores |
79.35; 82.94; 60.69; 57.62; 85.92; 83.60 | — |
| SECONDARY Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores |
86.24; 81.49; 85.65; 78.65; 83.77; 57.38 | — |
| SECONDARY Median Duration of Rituximab Administration for Each Treatment Cycle |
4.0; 4.0; 0.1; 3.0; 0.1; 2.8 | — |
| SECONDARY Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle |
0; 0; 0; 0.5; 1.4; 0 | — |
| SECONDARY Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle |
0.3; 0; 3.0; 1.5; 19.8; 20.7 | — |
| SECONDARY Number of Participants With an Event-Free Survival (EFS) Event |
116; 53 | — |
| SECONDARY Duration of EFS |
NA; NA | — |
| SECONDARY Number of Participants With Relapse or Death at the Time of Primary Analysis |
12; 5 | — |
| SECONDARY Duration of Disease-Free Survival (DFS) |
NA; NA | — |
| SECONDARY Number of Participants With Progression, Relapse, or Death |
95; 38 | — |
| SECONDARY Duration of Progression-Free Survival (PFS) |
NA; NA | — |
| SECONDARY Number of Deaths |
56; 22 | — |
| SECONDARY Duration of Overall Survival (OS) |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 and /= 7.5 cm
- At least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
- Adequate hematologic function
- Eastern Cooperative Oncology Group (EOCD) performance status /= 5 years prior to enrolment
- Inadequate renal or hepatic function
- Known human immunodeficiency virus (HIV) infection or HIV seropositive status
- Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
- Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01649856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.