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Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00278161
Recruitment Status : Completed
First Posted : January 18, 2006
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: Pegfilgrastim
Biological: Rituximab
Drug: Cyclophosphamide
Enrollment 94
Recruitment Details  
Pre-assignment Details 16 participants were screen failures. IRB allowed 3 of those participants to be analyzed along with the 78 who were treated as part of the study. Because the 3 additional participants received the exact same protocol intervention, the total population for analysis purposes is 81.
Arm/Group Title R-HiCy
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Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.

Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.

Period Title: Overall Study
Started 81
Completed 70
Not Completed 11
Reason Not Completed
Death             11
Arm/Group Title R-HiCy
Hide Arm/Group Description

Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.

Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.

Overall Number of Baseline Participants 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
<=18 years
0
   0.0%
Between 18 and 65 years
71
  87.7%
>=65 years
10
  12.3%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 81 participants
17
  21.0%
Male Number Analyzed 81 participants
59
  72.8%
Unknown Number Analyzed 81 participants
5
   6.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Engraftment
Hide Description Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count >= 500 cells per microliter; platelet recovery is defined as untransfused platelet count >= 20 * 10^9 cells per liter.
Time Frame Up to 43 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title R-HiCy
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Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.

Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.

Overall Number of Participants Analyzed 81
Median (Full Range)
Unit of Measure: days
Neutrophil
15
(11 to 32)
Platelet
15
(0 to 43)
2.Primary Outcome
Title Non-relapse Mortality
Hide Description Number of participants who died for reasons related to protocol treatment.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title R-HiCy
Hide Arm/Group Description:

Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.

Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.

Overall Number of Participants Analyzed 81
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title Event-free Survival
Hide Description Percentage of participants alive without disease relapse.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants were split into two populations for this outcome only: mantle-cell lymphoma and other low-grade B-cell tumors.
Arm/Group Title R-HiCy
Hide Arm/Group Description:

Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.

Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.

Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: percentage of participants
Mantle-cell lymphoma Number Analyzed 39 participants
39
Other low-grade B-cell tumors Number Analyzed 42 participants
40
Time Frame Up to 1 year
Adverse Event Reporting Description Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
 
Arm/Group Title R-HiCy
Hide Arm/Group Description

Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Rituximab: 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.

Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.

All-Cause Mortality
R-HiCy
Affected / at Risk (%)
Total   11/81 (13.58%)    
Show Serious Adverse Events Hide Serious Adverse Events
R-HiCy
Affected / at Risk (%) # Events
Total   15/81 (18.52%)    
Blood and lymphatic system disorders   
Secondary malignancy - acute myeloid leukemia  1  1/81 (1.23%)  1
Cardiac disorders   
Atrial fibrillation with rapid ventricular response  1  1/81 (1.23%)  1
Hypotension  1  1/81 (1.23%)  1
Gastrointestinal disorders   
Constipation  1  1/81 (1.23%)  1
General disorders   
Dehydration  1  1/81 (1.23%)  1
Fever  1  1/81 (1.23%)  1
Infections and infestations   
Bacteremia  1  2/81 (2.47%)  2
Febrile neutropenia  1  6/81 (7.41%)  6
Infection (unspecified)  1  1/81 (1.23%)  1
Investigations   
Lipase elevated  1  1/81 (1.23%)  1
Musculoskeletal and connective tissue disorders   
Pain - wrist  1  1/81 (1.23%)  1
Nervous system disorders   
Syncope  1  1/81 (1.23%)  1
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%
R-HiCy
Affected / at Risk (%) # Events
Total   64/81 (79.01%)    
Cardiac disorders   
Edema  1  5/81 (6.17%)  5
Hypertension  1  8/81 (9.88%)  8
Hypotension  1  13/81 (16.05%)  14
Orthostatic hypotension  1  5/81 (6.17%)  6
Tachycardia  1  7/81 (8.64%)  8
Gastrointestinal disorders   
Anorexia  1  17/81 (20.99%)  18
Bloating  1  4/81 (4.94%)  4
Constipation  1  10/81 (12.35%)  10
Diarrhea  1  21/81 (25.93%)  22
Hiccups  1  5/81 (6.17%)  5
Nausea  1  45/81 (55.56%)  59
Vomiting  1  33/81 (40.74%)  40
General disorders   
Chills  1  4/81 (4.94%)  4
Cough  1  10/81 (12.35%)  10
Fatigue  1  30/81 (37.04%)  33
Headache  1  16/81 (19.75%)  21
Insomnia  1  12/81 (14.81%)  12
Pain - abdomen  1  5/81 (6.17%)  5
Pain - central catheter site  1  6/81 (7.41%)  6
Rigors  1  6/81 (7.41%)  6
Diaphoresis  1  4/81 (4.94%)  4
Weight gain  1  4/81 (4.94%)  4
Infections and infestations   
Febrile neutropenia  1  10/81 (12.35%)  10
Fever  1  12/81 (14.81%)  15
Investigations   
ALT high  1  9/81 (11.11%)  18
Anemia  1  8/81 (9.88%)  25
AST high  1  7/81 (8.64%)  12
Hyperglycemia  1  5/81 (6.17%)  23
Hyponatremia  1  4/81 (4.94%)  7
Leukopenia  1  27/81 (33.33%)  57
Neutropenia  1  32/81 (39.51%)  45
Thrombocytopenia  1  32/81 (39.51%)  100
Musculoskeletal and connective tissue disorders   
Myalgia  1  8/81 (9.88%)  8
Pain - back  1  5/81 (6.17%)  5
Pain - bone  1  6/81 (7.41%)  6
Pain - hip  1  6/81 (7.41%)  6
Nervous system disorders   
Dizziness  1  11/81 (13.58%)  11
Lightheadedness  1  8/81 (9.88%)  8
Neuropathy  1  13/81 (16.05%)  14
Psychiatric disorders   
Anxiety  1  10/81 (12.35%)  10
Depression  1  5/81 (6.17%)  5
Renal and urinary disorders   
Urinary frequency  1  13/81 (16.05%)  14
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  1  8/81 (9.88%)  8
Skin and subcutaneous tissue disorders   
Pain - mouth  1  10/81 (12.35%)  10
Rash  1  22/81 (27.16%)  26
Vascular disorders   
Hemorrhoids  1  5/81 (6.17%)  5
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lode Swinnen, MD
Organization: Johns Hopkins University
Phone: 4106146398
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00278161     History of Changes
Other Study ID Numbers: J0260
P50CA096888 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
NA_00041511 ( Other Identifier: JHMIRB )
First Submitted: January 16, 2006
First Posted: January 18, 2006
Results First Submitted: October 4, 2018
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018