Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the mucosa associated lymphoid tissue (MALT).
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma of Mucosa-Associated Lymphoid Tissue |
Drug: Rituximab Drug: 2-CdA |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) |
- Response rate [ Time Frame: After 2, 4 and 6 cycles of therapy ] [ Designated as safety issue: No ]
- Progression-free survival and relapse-free survival [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Occurrence of adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Arm
Combination therapy Rituximab plus 2CdA
|
Drug: Rituximab
375 mg/m2 on day 1 of a 21-day treatment cycle
Other Name: MabThera
Drug: 2-CdA
0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle
Other Name: Litak
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Austria | |
| Universitätsklinikum Graz | |
| Graz, Austria, A-8036 | |
| Universitaetsklinik Innsbruck/ Klinik für Innere Medizin | |
| Innsbruck, Austria, A-6020 | |
| Krankenhaus der Stadt Linz | |
| Linz, Austria, A-4020 | |
| Universitaetsklinik f. Innere Medizin III | |
| Salzburg, Austria, A-5020 | |
| AKH Wien / Universitaetsklinik fuer Innere Medizin I | |
| Vienna, Austria, A-1090 | |
| Principal Investigator: | Markus Raderer, Prof. Dr. | AKH Wien / Universitaetsklinik fuer Innere Medizin I |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie |
| ClinicalTrials.gov Identifier: | NCT00656812 History of Changes |
| Other Study ID Numbers: | AGMT_MALT, EudraCT 2008-000767-41 |
| Study First Received: | April 2, 2008 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
|
advanced MALT lymphoma Rituximab 2CdA chemotherapy immunotherapy |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin 2-chloro-3'-deoxyadenosine Rituximab |
Cladribine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013