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Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00940342
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: GM-CSF (Sargramostim)
Drug: Rituximab
Enrollment 130

Recruitment Details Recruitment Period: October 2004 through January 2007. Of the 130 participants recruited, 119 participants were recruited at The University of Texas (UT) MD Anderson Cancer Center, 6 at The University of California San Diego, and 5 participants were recruited at Dana Farber Cancer Institute.
Pre-assignment Details  
Arm/Group Title Treated and Relapsed - Group 1 Untreated and High-Risk for Progression - Group 2 70 Years of Age and Refused Chemo - Group 3
Hide Arm/Group Description

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Period Title: Overall Study
Started 50 40 40
Completed 50 38 39
Not Completed 0 2 1
Reason Not Completed
Adverse Event             0             2             1
Arm/Group Title Treated and Relapsed - Group 1 Untreated and High-Risk for Progression - Group 2 70 Years of Age and Refused Chemo - Group 3 Total
Hide Arm/Group Description

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Total of all reporting groups
Overall Number of Baseline Participants 50 40 40 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 40 participants 40 participants 130 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  40.0%
36
  90.0%
0
   0.0%
56
  43.1%
>=65 years
30
  60.0%
4
  10.0%
40
 100.0%
74
  56.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants 40 participants 40 participants 130 participants
68
(41 to 84)
56.5
(34 to 70)
73
(70 to 83)
69
(34 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 40 participants 40 participants 130 participants
Female
16
  32.0%
19
  47.5%
14
  35.0%
49
  37.7%
Male
34
  68.0%
21
  52.5%
26
  65.0%
81
  62.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 40 participants 40 participants 130 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.0%
2
   5.0%
4
  10.0%
7
   5.4%
White
49
  98.0%
38
  95.0%
36
  90.0%
123
  94.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 40 participants 40 participants 130 participants
50 40 40 130
1.Primary Outcome
Title Overall Response Rate
Hide Description Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, <30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes < 4,000ul , Hemoglobin >11.0 g/dl , Platelets >1000,000/ul, Polymorphonuclear neutrophils (PMN) >1,500/ul, Liver/Spleen not palpable, Nodes none. PR is <30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes >50% decrease, Hemoglobin (un-transfused) > 11.0 g/dl or >50% improvement from baseline, Platelets > 100,000/ul or 50% improvement from baseline, PMN >1,500 ul or 50% improvement from baseline, Liver/Spleen >/= 50% decrease, Nodes >/= 50%.
Time Frame Blood tests once a week during 8 weeks of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated and Relapsed - Group 1 Untreated and High-Risk for Progression - Group 2 70 Years of Age and Refused Chemo - Group 3
Hide Arm/Group Description:

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Overall Number of Participants Analyzed 50 38 39
Measure Type: Count of Participants
Unit of Measure: Participants
23
  46.0%
31
  81.6%
23
  59.0%
Time Frame Adverse events captured from the time of participant consent and will be followed to resolution or stabilization. Adverse events reported during each treatment course, up to 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treated and Relapsed - Group 1 Untreated and High-Risk for Progression - Group 2 70 Years of Age and Refused Chemo - Group 3
Hide Arm/Group Description

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks.

Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks

All-Cause Mortality
Treated and Relapsed - Group 1 Untreated and High-Risk for Progression - Group 2 70 Years of Age and Refused Chemo - Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/50 (6.00%)      0/40 (0.00%)      1/40 (2.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treated and Relapsed - Group 1 Untreated and High-Risk for Progression - Group 2 70 Years of Age and Refused Chemo - Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/50 (10.00%)      3/40 (7.50%)      4/40 (10.00%)    
Blood and lymphatic system disorders       
Hemolysis  1  0/50 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
General disorders       
Fever  1  2/50 (4.00%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
Pain  1  0/50 (0.00%)  0 2/40 (5.00%)  2 1/40 (2.50%)  1
Fatigue  1  0/50 (0.00%)  0 0/40 (0.00%)  0 0/40 (0.00%)  0
Infections and infestations       
Neutropenic Fever  1  2/50 (4.00%)  3 0/40 (0.00%)  0 0/40 (0.00%)  0
Infection  1  1/50 (2.00%)  1 1/40 (2.50%)  1 0/40 (0.00%)  0
Metabolism and nutrition disorders       
Hyponatremia  1  0/50 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders       
Muscle Weakness  1  1/50 (2.00%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
Nervous system disorders       
Confusion  1  1/50 (2.00%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  0/50 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
Vascular disorders       
Ischemia  1  0/50 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  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%
Treated and Relapsed - Group 1 Untreated and High-Risk for Progression - Group 2 70 Years of Age and Refused Chemo - Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/50 (42.00%)      16/40 (40.00%)      15/40 (37.50%)    
Blood and lymphatic system disorders       
Thrombocytopenia  1  3/50 (6.00%)  3 0/40 (0.00%)  0 2/40 (5.00%)  2
General disorders       
Pain  1  4/50 (8.00%)  4 4/40 (10.00%)  4 1/40 (2.50%)  1
Fever  1  3/50 (6.00%)  3 1/40 (2.50%)  1 1/40 (2.50%)  1
Chills  1  3/50 (6.00%)  3 0/40 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations       
Neutropenia  1  11/50 (22.00%)  11 4/40 (10.00%)  4 6/40 (15.00%)  6
Respiratory, thoracic and mediastinal disorders       
Shortness of Breath  1  0/50 (0.00%)  0 0/40 (0.00%)  0 2/40 (5.00%)  2
Skin and subcutaneous tissue disorders       
Injection Site Reaction  1  6/50 (12.00%)  6 10/40 (25.00%)  10 10/40 (25.00%)  10
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: Alessandra Ferrajoli, MD/Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00940342     History of Changes
Other Study ID Numbers: 2004-0102
NCI-2012-01670 ( Registry Identifier: NCI CTRP )
First Submitted: July 14, 2009
First Posted: July 16, 2009
Results First Submitted: February 26, 2018
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018