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Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

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ClinicalTrials.gov Identifier: NCT01611259
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Intervention Drug: Rituximab and Lenalidomide
Enrollment 50
Recruitment Details 50 patients were enrolled at 4 sites in Austria. First patient in was 06-Jun-2012; Last patient in was 26-May-2014.
Pre-assignment Details 2 patients were withdrawn before first response evaluation and were replaced. 2 patients withdrew their consents prior to study treatment and did not experience AEs to other study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.
Arm/Group Title Rituximab and Lenalidomide
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 48
Completed 34
Not Completed 14
Reason Not Completed
Physician Decision             1
Lack of Efficacy             2
Adverse Event             4
Withdrawal by Subject             7
Arm/Group Title Rituximab and Lenalidomide
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants
65
(33 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
29
  60.4%
Male
19
  39.6%
1.Primary Outcome
Title Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
Hide Description 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.
Time Frame 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab and Lenalidomide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
CR
25
  54.3%
PR or SD
20
  43.5%
PD
1
   2.2%
2.Secondary Outcome
Title Number and Severity of Adverse Events
Hide Description Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population
Time Frame From treatment start until 28 days after last study treatment; expected study duration 24 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Influence of Rituximab Plus Lenalidomide on T-cell Subsets
Hide Description T-cell subsets will be evaluated from EDTA blood in a central lab
Time Frame Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5
Outcome Measure Data Not Reported
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab and Lenalidomide
Hide Arm/Group Description 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.
All-Cause Mortality
Rituximab and Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab and Lenalidomide
Affected / at Risk (%) # Events
Total   18/48 (37.50%)    
Blood and lymphatic system disorders   
Anemia  1  1/48 (2.08%)  1
Gastrointestinal disorders   
Diarrhea  1  1/48 (2.08%)  1
Gastric haemorrhage  1  1/48 (2.08%)  1
Vomiting  1  1/48 (2.08%)  1
General disorders   
Pain  1  1/48 (2.08%)  1
Pyrexia  1  2/48 (4.17%)  2
Hepatobiliary disorders   
Colecystitis  1  1/48 (2.08%)  1
Infections and infestations   
Bacterial infection  1  1/48 (2.08%)  1
Bronchitis  1  1/48 (2.08%)  1
Infection  1  1/48 (2.08%)  1
Lung infection  1  1/48 (2.08%)  1
Skin infection  1  1/48 (2.08%)  1
Injury, poisoning and procedural complications   
Infusion related reaction  1  1/48 (2.08%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/48 (2.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  1/48 (2.08%)  1
Renal and urinary disorders   
Renal failure  1  1/48 (2.08%)  1
Urinary retention  1  1/48 (2.08%)  1
Skin and subcutaneous tissue disorders   
Rash  1  2/48 (4.17%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.17%
Rituximab and Lenalidomide
Affected / at Risk (%) # Events
Total   47/48 (97.92%)    
Blood and lymphatic system disorders   
Leucocyte count  1  6/48 (12.50%)  15
Eye disorders   
Conjunctivitis  1  2/48 (4.17%)  3
Gastrointestinal disorders   
Abdominal pain upper  1  2/48 (4.17%)  2
Constipation  1  10/48 (20.83%)  11
Diarrhoea  1  9/48 (18.75%)  16
Dry mouth  1  4/48 (8.33%)  5
Dysgeusia  1  3/48 (6.25%)  3
Dyspepsia  1  3/48 (6.25%)  4
Gastroenteritis  1  2/48 (4.17%)  2
Gastrointestinal pain  1  3/48 (6.25%)  3
Meteorism  1  2/48 (4.17%)  2
Nausea  1  7/48 (14.58%)  10
Stomatitis  1  2/48 (4.17%)  3
Vomiting  1  5/48 (10.42%)  5
General disorders   
Chills  1  9/48 (18.75%)  10
Condition aggravated  1  2/48 (4.17%)  2
Fatigue  1  17/48 (35.42%)  20
Infusion related reaction  1  2/48 (4.17%)  4
Mucositis  1  2/48 (4.17%)  3
Night sweats  1  3/48 (6.25%)  4
Oedema peripheral  1  5/48 (10.42%)  6
Pyrexia  1  8/48 (16.67%)  9
Immune system disorders   
Hypersensitivity  1  5/48 (10.42%)  6
Infections and infestations   
Bronchitis  1  2/48 (4.17%)  2
Infection  1  2/48 (4.17%)  2
Nasopharyngitis  1  2/48 (4.17%)  2
Oral herpes  1  4/48 (8.33%)  4
Injury, poisoning and procedural complications   
Overdose  1  3/48 (6.25%)  3
Investigations   
Alanine aminotransferase increased  1  2/48 (4.17%)  2
Haemoglobin  1  3/48 (6.25%)  5
Lymphocyte count  1  3/48 (6.25%)  6
Neutrophil count  1  12/48 (25.00%)  28
Platelet count  1  3/48 (6.25%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/48 (8.33%)  5
Muscle spasms  1  6/48 (12.50%)  8
Musculoskeletal pain  1  11/48 (22.92%)  15
Nervous system disorders   
Headache  1  6/48 (12.50%)  11
Insomnia  1  5/48 (10.42%)  6
Tremor  1  2/48 (4.17%)  3
Vertigo  1  11/48 (22.92%)  12
Renal and urinary disorders   
Nocturia  1  2/48 (4.17%)  2
Urinary tract infection  1  6/48 (12.50%)  6
Respiratory, thoracic and mediastinal disorders   
Cough  1  11/48 (22.92%)  11
Oropharyngeal pain  1  3/48 (6.25%)  3
Skin and subcutaneous tissue disorders   
Eyelid oedema  1  2/48 (4.17%)  5
Pruritus  1  23/48 (47.92%)  34
Rash  1  23/48 (47.92%)  39
Skin ulcer  1  2/48 (4.17%)  2
Vascular disorders   
Thrombosis  1  2/48 (4.17%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public contact Daniela Wolkersdorfer
Organization: AGMT
Phone: 00436626404411
EMail: d.wolkersdorfer@agmt.at
Layout table for additonal information
Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01611259     History of Changes
Other Study ID Numbers: AGMT_MALT2
First Submitted: May 18, 2012
First Posted: June 4, 2012
Results First Submitted: June 21, 2016
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017