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Trial record 25 of 201 for:    "Leukemia" | "Sargramostim"

Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI

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ClinicalTrials.gov Identifier: NCT00363649
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : November 12, 2018
Last Update Posted : November 12, 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 Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: GM-K562 cell vaccine
Biological: Interferon alfa
Biological: Sargramostim
Enrollment 36
Recruitment Details  
Pre-assignment Details Two participants were screen failures.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

Period Title: Overall Study
Started 18 16
Crossed Over to Arm B 9 0
Crossed Over to Arm A 0 12
Did Not Cross Over 2 3
Completed 11 15
Not Completed 7 1
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             6             0
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
16
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
43
(23 to 64)
40
(27 to 64)
40.5
(23 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
10
  55.6%
10
  62.5%
20
  58.8%
Male
8
  44.4%
6
  37.5%
14
  41.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
17
  94.4%
15
  93.8%
32
  94.1%
Unknown or Not Reported
1
   5.6%
1
   6.3%
2
   5.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  11.1%
1
   6.3%
3
   8.8%
White
15
  83.3%
14
  87.5%
29
  85.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.6%
1
   6.3%
2
   5.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 34 participants
18
 100.0%
16
 100.0%
34
 100.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Number of patients alive and without disease progression or relapse
Time Frame 1 year after treatment has been stopped
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

Overall Number of Participants Analyzed 18 16
Measure Type: Count of Participants
Unit of Measure: Participants
2
  11.1%
0
   0.0%
2.Primary Outcome
Title Complete Remission Rate
Hide Description Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

Overall Number of Participants Analyzed 18 16
Measure Type: Number
Unit of Measure: percentage of participants
61.1 62.5
3.Secondary Outcome
Title Time to Complete Molecular Remission
Hide Description Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity.
Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

Overall Number of Participants Analyzed 18 16
Median (95% Confidence Interval)
Unit of Measure: months
10
(4.7 to 11.2)
16.3
(6.9 to 27)
4.Secondary Outcome
Title Disease-free Survival
Hide Description Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol.
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

Overall Number of Participants Analyzed 18 16
Median (Full Range)
Unit of Measure: days
82
(28 to 2924)
98
(56 to 116)
5.Secondary Outcome
Title Early Discontinuation
Hide Description Number of participants unable to complete protocol-specified treatment due to toxicity.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome includes all participants who were either started on an arm or crossed over to an arm.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

Overall Number of Participants Analyzed 30 25
Measure Type: Count of Participants
Unit of Measure: Participants
10
  33.3%
0
   0.0%
Time Frame Up to 2 years
Adverse Event Reporting Description Adverse events were collected monthly for up to two years.
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description

Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.

Interferon alfa: Given by injection

Sargramostim: Given by injection

Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).

GM-K562 cell vaccine: Given by injection

All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/25 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      0/25 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
New malignancy - breast cancer  1  1/30 (3.33%)  1 0/25 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/30 (3.33%)  1 0/25 (0.00%)  0
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 0%
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/30 (100.00%)      25/25 (100.00%)    
Blood and lymphatic system disorders     
Edema  1  12/30 (40.00%)  19 10/25 (40.00%)  17
Hidradentitis  1  1/30 (3.33%)  1 1/25 (4.00%)  1
Cardiac disorders     
Hypertension  1  1/30 (3.33%)  1 3/25 (12.00%)  3
Eye disorders     
Conjunctivitis  1  2/30 (6.67%)  3 1/25 (4.00%)  1
Watery eyes  1  2/30 (6.67%)  2 2/25 (8.00%)  3
Gastrointestinal disorders     
Acid reflux  1  1/30 (3.33%)  1 3/25 (12.00%)  4
Constipation  1  2/30 (6.67%)  3 1/25 (4.00%)  1
Diarrhea  1  7/30 (23.33%)  11 4/25 (16.00%)  6
Indigestion  1  2/30 (6.67%)  2 0/25 (0.00%)  0
Nausea  1  11/30 (36.67%)  11 5/25 (20.00%)  5
Pain - abdomen  1  3/30 (10.00%)  4 1/25 (4.00%)  2
Pain - throat  1  4/30 (13.33%)  4 7/25 (28.00%)  9
Vomiting  1  2/30 (6.67%)  2 4/25 (16.00%)  4
Xerostomia  1  2/30 (6.67%)  2 2/25 (8.00%)  2
General disorders     
Alopecia  1  4/30 (13.33%)  4 3/25 (12.00%)  3
Anorexia  1  6/30 (20.00%)  7 0/25 (0.00%)  0
Chills  1  2/30 (6.67%)  2 1/25 (4.00%)  1
Dehydration  1  1/30 (3.33%)  1 2/25 (8.00%)  2
Fatigue  1  19/30 (63.33%)  32 15/25 (60.00%)  34
Flu-like symptoms  1  18/30 (60.00%)  28 6/25 (24.00%)  8
Insomnia  1  6/30 (20.00%)  6 0/25 (0.00%)  0
Malaise  1  1/30 (3.33%)  1 1/25 (4.00%)  1
Night sweats  1  3/30 (10.00%)  3 1/25 (4.00%)  1
Pain - ear  1  2/30 (6.67%)  2 0/25 (0.00%)  0
Pain - generalized  1  4/30 (13.33%)  4 3/25 (12.00%)  3
Pain - head  1  8/30 (26.67%)  12 8/25 (32.00%)  19
Rigors  1  2/30 (6.67%)  5 0/25 (0.00%)  0
Weight gain  1  1/30 (3.33%)  1 2/25 (8.00%)  2
Immune system disorders     
Adenopathy  1  5/30 (16.67%)  5 3/25 (12.00%)  4
Allergic reaction  1  1/30 (3.33%)  1 1/25 (4.00%)  2
Injection site reaction  1  15/30 (50.00%)  23 25/25 (100.00%)  426
Seasonal allergies  1  1/30 (3.33%)  1 1/25 (4.00%)  1
Infections and infestations     
Fever  1  5/30 (16.67%)  9 5/25 (20.00%)  8
Gastroenteritis  1  4/30 (13.33%)  4 5/25 (20.00%)  5
Urinary tract infection  1  0/30 (0.00%)  0 4/25 (16.00%)  4
Infection - sinus  1  5/30 (16.67%)  7 9/25 (36.00%)  12
Infection - upper respiratory  1  3/30 (10.00%)  3 4/25 (16.00%)  6
Viral infection  1  2/30 (6.67%)  2 2/25 (8.00%)  2
Investigations     
ALT increased  1  8/30 (26.67%)  17 3/25 (12.00%)  5
Anemia  1  6/30 (20.00%)  12 5/25 (20.00%)  7
AST increased  1  7/30 (23.33%)  10 8/25 (32.00%)  13
Hyperglycemia  1  6/30 (20.00%)  10 5/25 (20.00%)  6
Hyperuricemia  1  4/30 (13.33%)  4 1/25 (4.00%)  1
Hypoalbuminemia  1  3/30 (10.00%)  4 0/25 (0.00%)  0
Hypocalcemia  1  6/30 (20.00%)  8 2/25 (8.00%)  3
Hypoglycemia  1  1/30 (3.33%)  1 3/25 (12.00%)  3
Hypokalemia  1  4/30 (13.33%)  8 2/25 (8.00%)  3
Leukopenia  1  5/30 (16.67%)  14 8/25 (32.00%)  15
Lymphopenia  1  7/30 (23.33%)  11 3/25 (12.00%)  4
Thrombocytopenia  1  4/30 (13.33%)  9 2/25 (8.00%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/30 (6.67%)  3 1/25 (4.00%)  1
Myalgia  1  7/30 (23.33%)  9 3/25 (12.00%)  4
Pain - back  1  5/30 (16.67%)  7 0/25 (0.00%)  0
Pain - bone  1  3/30 (10.00%)  3 2/25 (8.00%)  8
Pain - leg  1  6/30 (20.00%)  8 0/25 (0.00%)  0
Ankle sprain  1  1/30 (3.33%)  1 1/25 (4.00%)  1
Nervous system disorders     
Dizziness  1  3/30 (10.00%)  5 3/25 (12.00%)  3
Lightheadedness  1  0/30 (0.00%)  0 2/25 (8.00%)  2
Migraine  1  0/30 (0.00%)  0 2/25 (8.00%)  2
Weakness  1  1/30 (3.33%)  1 1/25 (4.00%)  1
Psychiatric disorders     
Depression  1  2/30 (6.67%)  2 1/25 (4.00%)  2
Reproductive system and breast disorders     
Menstrual cycle changes  1  4/30 (13.33%)  4 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchitis  1  3/30 (10.00%)  3 2/25 (8.00%)  2
Cough  1  4/30 (13.33%)  4 6/25 (24.00%)  7
Dyspnea  1  4/30 (13.33%)  5 3/25 (12.00%)  4
Nasal congestion  1  3/30 (10.00%)  4 7/25 (28.00%)  9
Nasal drip  1  2/30 (6.67%)  2 3/25 (12.00%)  4
Post-nasal drip  1  1/30 (3.33%)  2 2/25 (8.00%)  2
Skin and subcutaneous tissue disorders     
Itching  1  2/30 (6.67%)  2 0/25 (0.00%)  0
Pigmentation changes  1  1/30 (3.33%)  1 2/25 (8.00%)  2
Eye swelling  1  1/30 (3.33%)  1 1/25 (4.00%)  1
Rash  1  10/30 (33.33%)  12 6/25 (24.00%)  6
Xerosis  1  1/30 (3.33%)  1 1/25 (4.00%)  1
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
Layout table for Results Point of Contact information
Name/Title: Doug Smith, MD
Organization: Johns Hopkins University
Phone: 4102872935
EMail: smithdo@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00363649     History of Changes
Other Study ID Numbers: J05121
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2006
First Posted: August 15, 2006
Results First Submitted: October 10, 2018
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018