Trial Outcomes & Findings for Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients (NCT NCT00577993)
NCT ID: NCT00577993
Last Updated: 2020-11-16
Results Overview
Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
10 Years
Results posted on
2020-11-16
Participant Flow
Recruitment period: March 1998 to May 2002
35 participants without Bcl Gene rearrangement were not randomized to the study
Participant milestones
| Measure |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
|
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
|
Patients Without Bcl Gene Rearrangement
ATT9 cycles; Rituximab 6 cycles
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
90
|
35
|
|
Overall Study
COMPLETED
|
78
|
80
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
3
|
Reasons for withdrawal
| Measure |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
|
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
|
Patients Without Bcl Gene Rearrangement
ATT9 cycles; Rituximab 6 cycles
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Conversion
|
2
|
5
|
0
|
|
Overall Study
Uninsured
|
1
|
0
|
0
|
Baseline Characteristics
No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
Baseline characteristics by cohort
| Measure |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
n=78 Participants
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
|
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
n=80 Participants
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
|
Patients w/o Bcl Gene Rearrangement
n=35 Participants
ATT 9 cycles; Rituximab 6 cycles
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
n=78 Participants
|
54 years
n=80 Participants
|
51 years
n=35 Participants
|
52 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=78 Participants
|
34 Participants
n=80 Participants
|
18 Participants
n=35 Participants
|
103 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=78 Participants
|
46 Participants
n=80 Participants
|
17 Participants
n=35 Participants
|
90 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=78 Participants
|
5 Participants
n=80 Participants
|
4 Participants
n=35 Participants
|
13 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=78 Participants
|
64 Participants
n=80 Participants
|
27 Participants
n=35 Participants
|
158 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=78 Participants
|
11 Participants
n=80 Participants
|
4 Participants
n=35 Participants
|
22 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=78 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=78 Participants
|
1 Participants
n=80 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=78 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=78 Participants
|
1 Participants
n=80 Participants
|
3 Participants
n=35 Participants
|
11 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=78 Participants
|
67 Participants
n=80 Participants
|
28 Participants
n=35 Participants
|
158 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=78 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=78 Participants
|
11 Participants
n=80 Participants
|
4 Participants
n=35 Participants
|
22 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=78 Participants
|
77 participants
n=80 Participants
|
34 participants
n=35 Participants
|
187 participants
n=193 Participants
|
|
Region of Enrollment
United Arab Emirates
|
0 participants
n=78 Participants
|
1 participants
n=80 Participants
|
0 participants
n=35 Participants
|
1 participants
n=193 Participants
|
|
Region of Enrollment
China
|
0 participants
n=78 Participants
|
1 participants
n=80 Participants
|
1 participants
n=35 Participants
|
2 participants
n=193 Participants
|
|
Region of Enrollment
Panama
|
0 participants
n=78 Participants
|
1 participants
n=80 Participants
|
0 participants
n=35 Participants
|
1 participants
n=193 Participants
|
|
Region of Enrollment
Malta
|
1 participants
n=78 Participants
|
0 participants
n=80 Participants
|
0 participants
n=35 Participants
|
1 participants
n=193 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=78 Participants
|
0 participants
n=80 Participants
|
0 participants
n=35 Participants
|
1 participants
n=193 Participants
|
|
Indolent Lymphoma Subtype
FL
|
56 participants
n=78 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
55 participants
n=80 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
—
|
111 participants
n=158 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
|
Indolent Lymphoma Subtype
MZL
|
6 participants
n=78 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
12 participants
n=80 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
—
|
18 participants
n=158 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
|
Indolent Lymphoma Subtype
SLL
|
16 participants
n=78 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
13 participants
n=80 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
—
|
29 participants
n=158 Participants • No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
|
PRIMARY outcome
Timeframe: 10 YearsPopulation: The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years.
Outcome measures
| Measure |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
n=78 Participants
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
|
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
n=80 Participants
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
|
|---|---|---|
|
Number of Participants With Overall Survival (10 Years) by Treatment
|
59 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
n=78 Participants
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
|
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
n=80 Participants
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
|
|---|---|---|
|
Number of Participants With Progression Free Survival (10 Years) by Treatment
|
59 Participants
|
58 Participants
|
Adverse Events
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
Serious events: 67 serious events
Other events: 67 other events
Deaths: 19 deaths
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
Serious events: 77 serious events
Other events: 77 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
n=78 participants at risk
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
|
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
n=80 participants at risk
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
1.2%
1/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
General disorders
Fatigue
|
19.2%
15/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
15.0%
12/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
General disorders
Fever
|
1.3%
1/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
3.8%
3/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
2.6%
2/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
5.0%
4/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Infections and infestations
Infection
|
10.3%
8/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
18.8%
15/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Gastrointestinal disorders
Nausea/Emesis
|
5.1%
4/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
5.0%
4/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Neutropenia
|
85.9%
67/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
96.2%
77/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.2%
15/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
28.7%
23/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Anemia
|
12.8%
10/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
13.8%
11/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
Other adverse events
| Measure |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
n=78 participants at risk
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex
|
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
n=80 participants at risk
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
26.9%
21/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
20.0%
16/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
26/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
43.8%
35/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
General disorders
Fatigue
|
56.4%
44/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
60.0%
48/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
General disorders
Fever
|
17.9%
14/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
25.0%
20/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
17.9%
14/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
11.2%
9/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Infections and infestations
Infection
|
21.8%
17/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
22.5%
18/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Gastrointestinal disorders
Nausea / Emisis
|
9.0%
7/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
16.2%
13/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Nervous system disorders
Neuropathy
|
26.9%
21/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
17.5%
14/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Skin and subcutaneous tissue disorders
Rash / Pruitius
|
12.8%
10/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
22.5%
18/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Neutropenia
|
85.9%
67/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
16.2%
13/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.2%
15/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
17.5%
14/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
|
Blood and lymphatic system disorders
Anemia
|
12.8%
10/78 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
20.0%
16/80 • 10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
|
Additional Information
Nathan Fowler,MD, Clinical Professor, Lymphoma-Myeloma
UT MD Anderson Cancer Center
Phone: (832) 671-3018
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place