Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
18 Years
N/A
Both
Lymphoma of Mucosa-Associated Lymphoid Tissue
Trial Information
Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Currently, there is no chemotherapeutic standard treatment for patients with MALT lymphoma
either presenting with disseminated disease or with relapsing/refractory disease following
local treatment (including radiation) or eradication of HP. Various compounds have been
tested, including alkylating agents such as cyclophosphamide or chlorambucil, the nucleoside
analog cladribine (2CdA), as well as combination regimens including CHOP or MCP
(mitoxantrone, chlorambucil, prednisone), but only limited data exists from prospective
trials. Thus, trials to evaluate the potential of new compounds in patients with advanced
MALT lymphoma are not only justified, but seem warranted.
While systemic approaches were until recently thought to be justified only in patients with
disseminated disease, emerging data suggest that also patients with localized disease
potentially amenable to radiation may benefit from systemic treatment. This has been
demonstrated for ocular adnexal MALT lymphoma and recently also for gastric MALT lymphoma in
a randomized fashion, where application of chemotherapy resulted in a significantly longer
time to relapse as opposed to surgery or radiation without impairing overall survival.
Both 2CdA and rituximab have been demonstrated as active single agents in MALT lymphoma with
mild toxicity profiles and no data on combination therapy with rituximab plus chemotherapy
in MALT lymphoma have been published to date. This study will therefore evaluate the
efficacy and safety of Rituximab plus 2CdA in patients with advanced or relapsed lymphoma of
the mucose associated lymphoid tissue.
Inclusion Criteria:
- Histologically proven diagnosis of MALT lymphoma of any localization
- Disseminated disease upon diagnosis in case of gastric lymphoma or first or greater
relapse after local therapy (including gastrectomy or surgery), prior chemotherapy or
HP-eradication. In addition, also patients with localized gastric lymphoma judged
refractory to HP-eradication by a minimum follow-up of 12 months after successful
HP-eradication can be included in the study.
- Measurable disease
- ECOG performance status of 0,1 or 2
- Age at least 18 years
- Life expectancy of at least 3 months
- Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5
mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range (ULN), alkaline phosphatase <
2.5 x ULN, serum bilirubin < 2.0 mg/dl)
- Patient must be willing and able to comply with the protocol for the entire study
duration
- Women of child-bearing potential must have a negative pregnancy test and must agree
to use effective contraception for the entire treatment period
- Patient's written informed consent
Exclusion Criteria:
- Lymphoma histology other than MALT lymphoma or MALT lymphoma transforming to diffuse
large cell lymphoma ("high grade lymphoma")
- Use of any investigational agent 30 days prior to inclusion
- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the
skin or carcinoma in situ of the cervix within the last 5 years
- Major surgery, other than diagnostic surgery, within the last 4 weeks
- Evidence of CNS involvement
- A history of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the investigator to be clinically significant and adversely
affecting compliance to study drugs
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication)
or myocardial infarction within the last 6 months
- Inadequate hematological status at baseline prior to study entry: Dependency on red
blood cell and/or platelet transfusions, ANC (absolute neutrophile count (segmented +
bands) <1.0 x 109/L
- Patients with active opportunistic infections
- Pregnant or breast feeding women
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
After 2, 4 and 6 cycles of therapy
Safety Issue:
No
Principal Investigator
Markus Raderer, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
AKH Wien / Universitaetsklinik fuer Innere Medizin I
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
AGMT_MALT
NCT ID:
NCT00656812
Start Date:
May 2008
Completion Date:
December 2011
Related Keywords:
- Lymphoma of Mucosa-Associated Lymphoid Tissue
- advanced MALT lymphoma
- Rituximab
- 2CdA
- chemotherapy
- immunotherapy
- Lymphoma
- Lymphoma, B-Cell, Marginal Zone
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