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Trial record 19 of 201 for:    "Leukemia" | "Sargramostim"

Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00562328
Recruitment Status : Completed
First Posted : November 22, 2007
Results First Posted : May 8, 2012
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: Alemtuzumab
Biological: Rituximab
Biological: Sargramostim
Enrollment 33
Recruitment Details Thirty-three (33) participants were recruited at Mayo Clinic (Rochester and Arizona) between January 2008 and February 2010.
Pre-assignment Details All patients were deemed eligible.
Arm/Group Title Alemtuzumab + Rituximab + GM-CSF
Hide Arm/Group Description Alemtuzumab + Rituximab + GM-CSF
Period Title: Overall Study
Started 33
Completed 33
Not Completed 0
Arm/Group Title Alemtuzumab + Rituximab + GM-CSF
Hide Arm/Group Description Alemtuzumab + Rituximab + GM-CSF
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants
60
(42 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
10
  30.3%
Male
23
  69.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
Rai Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Stage 0 2
Stage 1 27
Stage 2 4
[1]
Measure Description:

Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity.

Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis and lymphadenopathy, Rai Stage II: Lymphocytosis and hepatomegaly +/- splenomegaly, Rai Stage III: Lymphocytosis and anemia, Rai Stage IV: Lymphocytosis and thrombocytopenia

CD38 Expression Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Positive (>=30%) 15
Negative (<30%) 18
[1]
Measure Description: This test is used to predict the rate of progression from diagnosis to need for treatment in CLL. Participants with positive CD38 (>=30%) tend to experience a more aggressive course of CLL.
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Mutated 3
Unmutated 30
[1]
Measure Description: IGVH testing helps predict which patients will experience a more aggressive (if the gene is unmutated, <=2%) or less aggressive (if the gene is mutated, >2%) course of CLL. This technically complex test is only available at select medical institutions.
ZAP-70 Expression   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Positive (>=20%) 25
Negative (<20%) 7
Unknown 1
[1]
Measure Description: This test is used to predict the rate of progression from diagnosis to need for treatment in CLL. Participants with positive ZAP-70 (>=20%) tend to experience a more aggressive course of CLL.
1.Primary Outcome
Title Proportion of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months
Hide Description

Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months:

  • CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy
  • PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab + Rituximab + GM-CSF
Hide Arm/Group Description:
Alemtuzumab + Rituximab + GM-CSF
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
31
2.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
Time Frame Time from registration to progression (up to 5 years)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Response
Hide Description Time to response (TTR) is defined as the time from registration to first documentation of response (CR or PR). In participants who do not achieve a response, time will be censored at the participants last evaluation (for disease) date. The median TTR with 95% CI was estimated using the Kaplan Meier method.
Time Frame time from registration to first documentation of response (up to 5 years)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR) is defined as the time from documentation of response (CR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method.
Time Frame time from start of response to progression (up to 5 years)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.
Time Frame Time from registration to death (up to 5 years)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to Subsequent Therapy
Hide Description Time to subsequent treatment (TTS) was defined as the time from end of active (protocol) treatment to the start of subsequent treatment. The median TTS with 95% CI was estimated using the Kaplan Meier method.
Time Frame time from end of protocol treatment to subsequent treatment (up to 5 years)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alemtuzumab + Rituximab + GM-CSF
Hide Arm/Group Description Alemtuzumab + Rituximab + GM-CSF
All-Cause Mortality
Alemtuzumab + Rituximab + GM-CSF
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alemtuzumab + Rituximab + GM-CSF
Affected / at Risk (%) # Events
Total   1/33 (3.03%)    
Infections and infestations   
Pneumonia  1  1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/33 (3.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alemtuzumab + Rituximab + GM-CSF
Affected / at Risk (%) # Events
Total   33/33 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  2/33 (6.06%)  2
Febrile neutropenia  1  1/33 (3.03%)  1
Eye disorders   
Vitreous hemorrhage  1  1/33 (3.03%)  1
Gastrointestinal disorders   
Constipation  1  1/33 (3.03%)  1
Mucositis oral  1  1/33 (3.03%)  1
Nausea  1  1/33 (3.03%)  1
General disorders   
Chills  1  3/33 (9.09%)  4
Fatigue  1  4/33 (12.12%)  5
Fever  1  24/33 (72.73%)  43
Injection site reaction  1  1/33 (3.03%)  1
Immune system disorders   
Hypersensitivity  1  1/33 (3.03%)  1
Infections and infestations   
Blood Infection  1  3/33 (9.09%)  5
Bronchial infection  1  1/33 (3.03%)  1
Infection without neutropenia  1  2/33 (6.06%)  5
Lip infection  1  1/33 (3.03%)  1
Opportunisitic infection  1  3/33 (9.09%)  6
Pharyngitis  1  2/33 (6.06%)  2
Pneumonia  1  1/33 (3.03%)  1
Respiratory tract infection  1  6/33 (18.18%)  9
Investigations   
Bilirubin  1  1/33 (3.03%)  3
Leukopenia  1  16/33 (48.48%)  39
Lymphocyte count decreased  1  1/33 (3.03%)  2
Neutrophil count decreased  1  7/33 (21.21%)  17
Platelet count decreased  1  1/33 (3.03%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/33 (3.03%)  1
Myalgia  1  1/33 (3.03%)  1
Pain in extremity  1  1/33 (3.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  1/33 (3.03%)  1
Skin and subcutaneous tissue disorders   
Dermatology  1  1/33 (3.03%)  1
Rash  1  25/33 (75.76%)  59
Sweating  1  2/33 (6.06%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Clive Zent
Organization: Mayo Clinic
EMail: zent.clive@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00562328     History of Changes
Other Study ID Numbers: CDR0000574754
P30CA015083 ( U.S. NIH Grant/Contract )
MC0785 ( Other Identifier: Mayo Clinic Cancer Center )
U4449s ( Other Identifier: Genentech )
001.0888 ( Other Identifier: Bayer )
07-002087 ( Other Identifier: Mayo Clinic IRB )
First Submitted: November 21, 2007
First Posted: November 22, 2007
Results First Submitted: April 11, 2012
Results First Posted: May 8, 2012
Last Update Posted: June 16, 2017