Trial Outcomes & Findings for R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial (NCT NCT01133158)
NCT ID: NCT01133158
Last Updated: 2018-11-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
7 years
Results posted on
2018-11-01
Participant Flow
Participant milestones
| Measure |
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
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 Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
Baseline characteristics by cohort
| Measure |
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
n=60 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 yearsPopulation: 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
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
Outcome measures
| Measure |
Induction Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
n=60 Participants
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
|
Maintenance Rituximab
n=43 Participants
Patient who had response to induction will receive Rituximab in maintenance
Rituximab: 375 mg / m2 every three months
|
|---|---|---|
|
Response Rate
|
57 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 7 yearsPopulation: Only those patients who started the maintenance treatmet were analyzed for Disease-Free Survival
Outcome measures
| Measure |
Induction Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
n=60 Participants
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
|
Maintenance Rituximab
Patient who had response to induction will receive Rituximab in maintenance
Rituximab: 375 mg / m2 every three months
|
|---|---|---|
|
Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Duration of the Response
|
54 months
Interval 36.0 to 54.0
|
—
|
|
Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Progression-Free Survival
|
56 months
Interval 28.0 to 56.0
|
—
|
|
Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Disease-Free Survival
|
51 months
Interval 36.0 to
Insufficient number of participants with events. Superior data to Disease-Free Survival is still not available
|
—
|
|
Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Global Survival
|
NA months
Insufficient number of participants with events. Global Survival data is still not available
|
—
|
Adverse Events
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Serious events: 22 serious events
Other events: 60 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
n=60 participants at risk
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
|
|---|---|
|
Infections and infestations
Infection
|
20.0%
12/60 • Number of events 20 • 9 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
2/60 • Number of events 5 • 9 years
|
|
General disorders
Fever
|
6.7%
4/60 • Number of events 4 • 9 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
10.0%
6/60 • Number of events 6 • 9 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Nervous system disorders
Leucoencephalopathy
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Renal and urinary disorders
Renal insufficiency
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Immune system disorders
Allergic reaction
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.7%
1/60 • Number of events 2 • 9 years
|
|
Surgical and medical procedures
Surgery
|
5.0%
3/60 • Number of events 3 • 9 years
|
|
Investigations
Progression suspicion
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Gastrointestinal disorders
Oral ulcer
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Cardiac disorders
Tachycardia
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Immune system disorders
Arthritis
|
1.7%
1/60 • Number of events 2 • 9 years
|
|
Metabolism and nutrition disorders
Hepatic insufficiency
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Metabolism and nutrition disorders
Immunodeficiency
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Nervous system disorders
Neuropathy caranial-CN VII
|
1.7%
1/60 • Number of events 1 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effussion
|
1.7%
1/60 • Number of events 1 • 9 years
|
Other adverse events
| Measure |
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
n=60 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
83.3%
50/60 • Number of events 318 • 9 years
|
|
Blood and lymphatic system disorders
Anemia
|
71.7%
43/60 • Number of events 144 • 9 years
|
|
Blood and lymphatic system disorders
plateletes
|
68.3%
41/60 • Number of events 135 • 9 years
|
|
General disorders
pain
|
35.0%
21/60 • Number of events 58 • 9 years
|
|
Infections and infestations
Infection
|
66.7%
40/60 • Number of events 79 • 9 years
|
|
General disorders
fatigue
|
30.0%
18/60 • Number of events 36 • 9 years
|
|
Metabolism and nutrition disorders
Metabolic/laboratory
|
75.0%
45/60 • Number of events 82 • 9 years
|
|
General disorders
Fever
|
33.3%
20/60 • Number of events 25 • 9 years
|
|
Gastrointestinal disorders
Diarrhea
|
18.3%
11/60 • Number of events 21 • 9 years
|
|
Gastrointestinal disorders
Vomiting
|
18.3%
11/60 • Number of events 15 • 9 years
|
|
Immune system disorders
Allergic reaction
|
13.3%
8/60 • Number of events 11 • 9 years
|
|
Skin and subcutaneous tissue disorders
mucositis
|
5.0%
3/60 • Number of events 11 • 9 years
|
|
Gastrointestinal disorders
constipation
|
13.3%
8/60 • Number of events 10 • 9 years
|
|
Infections and infestations
Febrile neutropenia
|
10.0%
6/60 • Number of events 6 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.3%
5/60 • Number of events 7 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
cold
|
8.3%
5/60 • Number of events 8 • 9 years
|
|
Psychiatric disorders
mood alteration
|
8.3%
5/60 • Number of events 7 • 9 years
|
|
Skin and subcutaneous tissue disorders
pruritus/itching
|
6.7%
4/60 • Number of events 5 • 9 years
|
|
Blood and lymphatic system disorders
other
|
6.7%
4/60 • Number of events 7 • 9 years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Number of events 4 • 9 years
|
|
Ear and labyrinth disorders
hearing
|
6.7%
4/60 • Number of events 7 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
dispnea
|
6.7%
4/60 • Number of events 5 • 9 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place