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R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial

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ClinicalTrials.gov Identifier: NCT01133158
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Intervention Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
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Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Period Title: Overall Study
Started 60
Completed 43
Not Completed 17
Arm/Group Title Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
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Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  53.3%
>=65 years
28
  46.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
62
(32 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
30
  50.0%
Male
30
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 60 participants
60
1.Primary Outcome
Title Response Rate
Hide Description

The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL

Complete Remission (CR):

Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved

Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD

Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD

Progressive Disease (PD):

SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion

Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants analyzed in the Maintenance Rituximab Arm reflects all participants who received at least one dose of Rituximab during maintenance, and had available data for response during that phase
Arm/Group Title Induction Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Maintenance Rituximab
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Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Patient who had response to induction will receive Rituximab in maintenance

Rituximab: 375 mg / m2 every three months

Overall Number of Participants Analyzed 60 43
Measure Type: Count of Participants
Unit of Measure: Participants
57
  95.0%
35
  81.4%
2.Secondary Outcome
Title Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Hide Description [Not Specified]
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only those patients who started the maintenance treatmet were analyzed for Disease-Free Survival
Arm/Group Title R-BMD
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Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Overall Number of Participants Analyzed 60
Median (Full Range)
Unit of Measure: months
Progression-Free Survival Number Analyzed 60 participants
56
(28 to 56)
Disease-Free Survival Number Analyzed 45 participants
51 [1] 
(36 to NA)
Global Survival Number Analyzed 60 participants
NA [2] 
(NA to NA)
Duration of the Response Number Analyzed 60 participants
54
(36 to 54)
[1]
Insufficient number of participants with events. Superior data to Disease-Free Survival is still not available
[2]
Insufficient number of participants with events. Global Survival data is still not available
Time Frame 9 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Hide Arm/Group Description

Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Patients with response will receive Rituximab in maintenance: 375 mg / m2 every three months

All-Cause Mortality
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Affected / at Risk (%)
Total   1/60 (1.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Affected / at Risk (%) # Events
Total   22/60 (36.67%)    
Blood and lymphatic system disorders   
Febrile Neutropenia   6/60 (10.00%)  6
Pancytopenia   1/60 (1.67%)  1
Neutropenia *  1/60 (1.67%)  1
Cardiac disorders   
Left ventricular systolic dysfunction *  1/60 (1.67%)  1
Tachycardia *  1/60 (1.67%)  1
Gastrointestinal disorders   
Diarrhea   2/60 (3.33%)  5
Intestinal Obstruction *  1/60 (1.67%)  2
Oral ulcer *  1/60 (1.67%)  1
General disorders   
Fever   4/60 (6.67%)  4
Immune system disorders   
Allergic reaction *  1/60 (1.67%)  1
Arthritis *  1/60 (1.67%)  2
Infections and infestations   
Infection *  12/60 (20.00%)  20
Investigations   
Progression suspicion *  1/60 (1.67%)  1
Metabolism and nutrition disorders   
Hepatic insufficiency *  1/60 (1.67%)  1
Immunodeficiency *  1/60 (1.67%)  1
Nervous system disorders   
Leucoencephalopathy *  1/60 (1.67%)  1
Neuropathy caranial-CN VII *  1/60 (1.67%)  1
Renal and urinary disorders   
Renal insufficiency   1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effussion *  1/60 (1.67%)  1
Surgical and medical procedures   
Surgery *  3/60 (5.00%)  3
Vascular disorders   
Orthostatic hypotension *  1/60 (1.67%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Affected / at Risk (%) # Events
Total   60/60 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia   50/60 (83.33%)  318
Anemia *  43/60 (71.67%)  144
plateletes *  41/60 (68.33%)  135
other *  4/60 (6.67%)  7
Ear and labyrinth disorders   
hearing *  4/60 (6.67%)  7
Gastrointestinal disorders   
Diarrhea *  11/60 (18.33%)  21
Vomiting *  11/60 (18.33%)  15
constipation *  8/60 (13.33%)  10
Nausea *  4/60 (6.67%)  4
General disorders   
pain *  21/60 (35.00%)  58
fatigue *  18/60 (30.00%)  36
Fever *  20/60 (33.33%)  25
Immune system disorders   
Allergic reaction *  8/60 (13.33%)  11
Infections and infestations   
Infection *  40/60 (66.67%)  79
Febrile neutropenia *  6/60 (10.00%)  6
Metabolism and nutrition disorders   
Metabolic/laboratory *  45/60 (75.00%)  82
Psychiatric disorders   
mood alteration *  5/60 (8.33%)  7
Respiratory, thoracic and mediastinal disorders   
cough *  5/60 (8.33%)  7
cold *  5/60 (8.33%)  8
dispnea *  4/60 (6.67%)  5
Skin and subcutaneous tissue disorders   
mucositis *  3/60 (5.00%)  11
pruritus/itching *  4/60 (6.67%)  5
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Francisco Javier Peñalver
Organization: GELTAMO
Phone: 91 621 98 24
Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT01133158     History of Changes
Other Study ID Numbers: R-BMD GELTAMO 08
First Submitted: February 11, 2010
First Posted: May 28, 2010
Results First Submitted: March 7, 2017
Results First Posted: November 1, 2018
Last Update Posted: November 1, 2018