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This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab and Lenalidomide | Experimental | Single arm: 6 cycles for patients with complete response, 8 cycles for subjects with stable disease or partial remission; cycles duration: 28 days Rituximab (Mabthera®): 375 mg/m² i.v. day 1 Lenalidomide (Revlimid®): 20 mg p.o. daily for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab and Lenalidomide | Drug | Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of < 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy. | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Severity of Adverse Events | Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population | From treatment start until 28 days after last study treatment; expected study duration 24 months |
| Influence of Rituximab Plus Lenalidomide on T-cell Subsets |
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Inclusion Criteria selected:
Exclusion Criteria selected:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Raderer, MD | Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Linz | Linz | Upper Austria | 4021 | Austria | ||
| Klin.Abt.f. Hämatologie; Med.Univ.Graz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27879257 | Result | Kiesewetter B, Willenbacher E, Willenbacher W, Egle A, Neumeister P, Voskova D, Mayerhoefer ME, Simonitsch-Klupp I, Melchardt T, Greil R, Raderer M; AGMT Investigators. A phase 2 study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma. Blood. 2017 Jan 19;129(3):383-385. doi: 10.1182/blood-2016-06-720599. Epub 2016 Nov 22. No abstract available. |
| Label | URL |
|---|---|
| Sponsor | View source |
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2 patients were withdrawn before first response evaluation and were replaced. 2 patients withdrew their consents prior to study treatment and did not experience AEs to other study procedures. These 2 patients were therefore excluded from intent-to-treat (ITT) efficacy assessments, safety assessments and listing of baseline characteristics.
50 patients were enrolled at 4 sites in Austria. First patient in was 06-Jun-2012; Last patient in was 26-May-2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab and Lenalidomide | Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two of the enrolled patients withdrew their consent prior to study treatment and did not experience adverse events due to other study procedures. These 2 patients were therefore excluded from intent-to-treat (ITT) and per-protocol (PP) efficacy assessments, safety assessments and listing of baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab and Lenalidomide | Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of < 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy. | 48 patients were included into safety assessment, two of them received treatment but no efficacy assessment was available. Therefore, these two patients were neither included into Intention-to-treat nor Per-protocol efficacy analysis. | Posted | Count of Participants | Participants | 40 weeks |
|
All AEs were recorded by the Investigator from the time the subject signs informed consent to 28 days after the last dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab and Lenalidomide | Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leucocyte count | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public contact Daniela Wolkersdorfer | AGMT | 00436626404411 | d.wolkersdorfer@agmt.at |
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| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
T-cell subsets will be evaluated from EDTA blood in a central lab |
| Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5 |
| Graz |
| A-8036 |
| Austria |
| Univ.-Klinik f. Innere Medizin V | Innsbruck | A-6020 | Austria |
| PMU Salzburg | Salzburg | 5020 | Austria |
| Universitätsklinik f. Innere Medizin I | Vienna | 1190 | Austria |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number and Severity of Adverse Events | Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population | Not Posted | From treatment start until 28 days after last study treatment; expected study duration 24 months | Participants |
| Secondary | Influence of Rituximab Plus Lenalidomide on T-cell Subsets | T-cell subsets will be evaluated from EDTA blood in a central lab | Not Posted | Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5 | Participants |
| 18 |
| 48 |
| 47 |
| 48 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Colecystitis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Meteorism | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mucositis | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Night sweats | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Lymphocyte count | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Platelet count | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eyelid oedema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |