Phase 3
N=454
Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
Lymphoma, Mucosa-Associated Lymphoid Tissue
Bottom Line
View on ClinicalTrials.gov: NCT00210353 ↗Enrolled (actual)
454
Serious AEs
9.2%
Results posted
Jun 2019
Primary outcome: Primary: Event-free-survival (EFS) — 51; 68; 51 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- chlorambucil (drug) (Drug); rituximab+chlorambucil (Drug); rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free-survival (EFS) |
51; 68; 51 | — |
| SECONDARY Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment |
85.5; 94.7; 78.3 | — |
| SECONDARY Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration |
70; 79; 66 | — |
| SECONDARY Progression-free-survival (PFS) |
59; 72; 57 | — |
| SECONDARY Overall Survival |
89; 90; 92 | — |
Summary
Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.
In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone
Eligibility Criteria
Inclusion Criteria
- histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
- any stage (Ann Arbor I-IV)
- either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
- no evidence of histologic transformation to a high grade lymphoma
- measurable or evaluable disease
- age > 18
- life expectancy of at least 1 year
- ECOG performance status 0-2
- no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
- no prior chemotherapy
- no prior immunotherapy with any anti-CD20 monoclonal antibody
- no prior radiotherapy in the last 6 weeks
- no corticosteroids during the last 28 days, unless prednisone chronically administered at a dose 3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement
- no major impairment of renal function (serum creatinine <1,5x upper normal) or liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement
- no evidence of active opportunistic infections
- no known HIV infection
- no active HBV and/or HCV infection
- no pregnant or lactating status
- appropriate contraceptive method in women of childbearing potential or men
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- informed consent must be given according to national/local regulations before randomization
Data sourced from ClinicalTrials.gov (NCT00210353). 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.