Trial Outcomes & Findings for FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years (NCT NCT00254410)
NCT ID: NCT00254410
Last Updated: 2019-05-01
Results Overview
Clinical Response Rate (combined morphological \[NCI Working Group (WG) criteria\] + flow cytometry criteria) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.
COMPLETED
PHASE2
30 participants
End of cycle 3
2019-05-01
Participant Flow
Recruitment Period: March 2005 to April 2006. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
FCM-R + Pegylated Filgrastim
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years
Baseline characteristics by cohort
| Measure |
FCM-R + Pegylated Filgrastim
n=30 Participants
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
57 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: End of cycle 3Clinical Response Rate (combined morphological \[NCI Working Group (WG) criteria\] + flow cytometry criteria) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.
Outcome measures
| Measure |
FCM-R + Pegylated Filgrastim
n=30 Participants
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
Clinical Response Rate at 3 Months
|
29 Participants
|
PRIMARY outcome
Timeframe: End of Cycle 6Population: One participant showed progression while on therapy and was taken off study after 3 courses. Of the 30 participants who started therapy, one participant was not analyzed at the end of cycle 6.
Clinical Response Rate (combined morphological \[NCI WG criteria\] + flow cytometry criteria) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.
Outcome measures
| Measure |
FCM-R + Pegylated Filgrastim
n=29 Participants
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
Clinical Response Rate at 6 Months
|
28 Participants
|
SECONDARY outcome
Timeframe: End of cycle 3Molecular response rate (PCR for immunoglobulin heavy chain (IgH) rearrangements) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.
Outcome measures
| Measure |
FCM-R + Pegylated Filgrastim
n=30 Participants
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
Molecular Response Rate at 3 Months
|
17 Participants
|
SECONDARY outcome
Timeframe: End of 6 monthsPopulation: One participant showed progression while on therapy and was taken off study after 3 courses. Of the 30 participants who started therapy, one participant was not analyzed at the end of cycle 6.
Molecular response rate (PCR for IgH rearrangements) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.
Outcome measures
| Measure |
FCM-R + Pegylated Filgrastim
n=29 Participants
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
Molecular Response Rate at 6 Months
|
10 Participants
|
Adverse Events
FCM-R + Pegylated Filgrastim
Serious adverse events
| Measure |
FCM-R + Pegylated Filgrastim
n=30 participants at risk
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
General disorders
Fever
|
6.7%
2/30 • Number of events 2 • Up to 10 months
|
|
Infections and infestations
Neutropenic Fever
|
10.0%
3/30 • Number of events 3 • Up to 10 months
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
3.3%
1/30 • Number of events 1 • Up to 10 months
|
Other adverse events
| Measure |
FCM-R + Pegylated Filgrastim
n=30 participants at risk
Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
86.7%
26/30 • Number of events 26 • Up to 10 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
80.0%
24/30 • Number of events 24 • Up to 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
76.7%
23/30 • Number of events 23 • Up to 10 months
|
|
Gastrointestinal disorders
Nausea
|
76.7%
23/30 • Number of events 23 • Up to 10 months
|
|
General disorders
Fatigue
|
60.0%
18/30 • Number of events 18 • Up to 10 months
|
|
General disorders
Fever
|
53.3%
16/30 • Number of events 16 • Up to 10 months
|
|
Infections and infestations
Neutropenic Fever
|
13.3%
4/30 • Number of events 4 • Up to 10 months
|
|
Gastrointestinal disorders
Vomiting
|
36.7%
11/30 • Number of events 11 • Up to 10 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.3%
7/30 • Number of events 7 • Up to 10 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
6/30 • Number of events 6 • Up to 10 months
|
|
General disorders
Chills
|
20.0%
6/30 • Number of events 6 • Up to 10 months
|
|
General disorders
Sweats
|
20.0%
6/30 • Number of events 6 • Up to 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Congestion
|
16.7%
5/30 • Number of events 5 • Up to 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
5/30 • Number of events 5 • Up to 10 months
|
|
Gastrointestinal disorders
Indigestion
|
13.3%
4/30 • Number of events 4 • Up to 10 months
|
|
General disorders
Joint/Bone Pain
|
13.3%
4/30 • Number of events 4 • Up to 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • Number of events 3 • Up to 10 months
|
|
General disorders
Body Aches
|
10.0%
3/30 • Number of events 3 • Up to 10 months
|
|
General disorders
Weakness
|
6.7%
2/30 • Number of events 2 • Up to 10 months
|
|
Immune system disorders
Autoimmune hemolytic anemia (AIHA)
|
6.7%
2/30 • Number of events 2 • Up to 10 months
|
|
Cardiac disorders
Hypotension
|
6.7%
2/30 • Number of events 2 • Up to 10 months
|
Additional Information
Wierda,William G, MD./Professor
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place