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FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years

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ClinicalTrials.gov Identifier: NCT00254410
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : December 6, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
OSI Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mitoxantrone
Drug: Rituximab
Drug: Filgrastim
Enrollment 30
Recruitment Details Recruitment Period: March 2005 to April 2006. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title FCM-R + Pegylated Filgrastim
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title FCM-R + Pegylated Filgrastim
Hide Arm/Group Description 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 Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  96.7%
>=65 years
1
   3.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
57
(38 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.3%
White
29
  96.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
1.Primary Outcome
Title Clinical Response Rate at 3 Months
Hide Description 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.
Time Frame End of cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FCM-R + Pegylated Filgrastim
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
29
  96.7%
2.Primary Outcome
Title Clinical Response Rate at 6 Months
Hide Description 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.
Time Frame End of Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FCM-R + Pegylated Filgrastim
Hide Arm/Group Description:
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 Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
28
  96.6%
3.Secondary Outcome
Title Molecular Response Rate at 3 Months
Hide Description Molecular 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.
Time Frame End of cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FCM-R + Pegylated Filgrastim
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
17
  56.7%
4.Secondary Outcome
Title Molecular Response Rate at 6 Months
Hide Description 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.
Time Frame End of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FCM-R + Pegylated Filgrastim
Hide Arm/Group Description:
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 Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
10
  34.5%
Time Frame Up to 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FCM-R + Pegylated Filgrastim
Hide Arm/Group Description 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.
All-Cause Mortality
FCM-R + Pegylated Filgrastim
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FCM-R + Pegylated Filgrastim
Affected / at Risk (%) # Events
Total   5/30 (16.67%)    
Endocrine disorders   
Diabetic Ketoacidosis  1  1/30 (3.33%)  1
General disorders   
Fever  1  2/30 (6.67%)  2
Infections and infestations   
Neutropenic Fever  1  3/30 (10.00%)  3
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FCM-R + Pegylated Filgrastim
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  26/30 (86.67%)  26
Thrombocytopenia  1  24/30 (80.00%)  24
Anemia  1  23/30 (76.67%)  23
Cardiac disorders   
Hypotension  1  2/30 (6.67%)  2
Gastrointestinal disorders   
Nausea  1  23/30 (76.67%)  23
Vomiting  1  11/30 (36.67%)  11
Constipation  1  6/30 (20.00%)  6
Indigestion  1  4/30 (13.33%)  4
Diarrhea  1  3/30 (10.00%)  3
General disorders   
Fatigue  1  18/30 (60.00%)  18
Fever  1  16/30 (53.33%)  16
Chills  1  6/30 (20.00%)  6
Sweats  1  6/30 (20.00%)  6
Joint/Bone Pain  1  4/30 (13.33%)  4
Body Aches  1  3/30 (10.00%)  3
Weakness  1  2/30 (6.67%)  2
Immune system disorders   
Autoimmune hemolytic anemia (AIHA)  1  2/30 (6.67%)  2
Infections and infestations   
Neutropenic Fever  1  4/30 (13.33%)  4
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Congestion  1  5/30 (16.67%)  5
Skin and subcutaneous tissue disorders   
Alopecia  1  7/30 (23.33%)  7
Rash  1  5/30 (16.67%)  5
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by 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: Wierda,William G, MD./Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-745-0428
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254410     History of Changes
Other Study ID Numbers: 2005-0106
NCI-2010-00437 ( Registry Identifier: NCI CTRP )
First Submitted: November 14, 2005
First Posted: November 16, 2005
Results First Submitted: November 13, 2018
Results First Posted: December 6, 2018
Last Update Posted: May 1, 2019