Trial Outcomes & Findings for A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation (NCT NCT00275262)
NCT ID: NCT00275262
Last Updated: 2010-05-06
Results Overview
Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.
TERMINATED
PHASE2
25 participants
Month 6 prevaccination (baseline) and Month 7 postvaccination
2010-05-06
Participant Flow
Participant milestones
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Disease progression
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Started Chemotherapy
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation
Baseline characteristics by cohort
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=12 Participants
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=13 Participants
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
49.0 years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 7.04 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6 prevaccination (baseline) and Month 7 postvaccinationPopulation: Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.
Outcome measures
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=8 Participants
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=5 Participants
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Mean IgM at baseline (mcg/mL)
|
4.0 mcg/mL
Standard Deviation 3.8 • Interval 0.99 to 7.38
|
3.0 mcg/mL
Standard Deviation 2.8 • Interval -0.16 to 1.84
|
|
Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Mean IgM change from baseline (mcg/mL)
|
2.91 mcg/mL
Standard Deviation 2.07
|
0.57 mcg/mL
Standard Deviation 0.83
|
PRIMARY outcome
Timeframe: Month 6 prevaccination (baseline) and Month 7 postvaccinationPopulation: Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.
Outcome measures
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=8 Participants
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=5 Participants
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Mean IgG1 at baseline (mcg/mL)
|
8.6 mcg/mL
Standard Deviation 9.1
|
10.8 mcg/mL
Standard Deviation 11.6
|
|
Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Mean IgG1 change from baseline (mcg/mL)
|
46.16 mcg/mL
Standard Deviation 44.01
|
16.76 mcg/mL
Standard Deviation 28.15
|
PRIMARY outcome
Timeframe: Month 6 prevaccination (baseline) and Month 7 postvaccinationPopulation: Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.
Outcome measures
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=6 Participants
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=5 Participants
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Mean interferon gamma at baseline
|
0.2 spots/1 million cells
Standard Deviation 3.2
|
-1.4 spots/1 million cells
Standard Deviation 3.2
|
|
Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Mean interferon gamma change from baseline
|
2.09 spots/1 million cells
Standard Deviation 4.85
|
10.25 spots/1 million cells
Standard Deviation 11.41
|
SECONDARY outcome
Timeframe: Pretransplant and posttransplant (Month 12)Population: Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010 The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells.
Outcome measures
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=9 Participants
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=7 Participants
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant
Baseline TREC per 100,000 CD4+ cells
|
67.524 TREC /100,000 CD4+ cells
Standard Deviation 47.0863
|
173.712 TREC /100,000 CD4+ cells
Standard Deviation 206.1733
|
|
Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant
Mean change in TREC from baseline to final visit
|
522.321 TREC /100,000 CD4+ cells
Standard Deviation 920.790
|
-63.950 TREC /100,000 CD4+ cells
Standard Deviation 235.561
|
SECONDARY outcome
Timeframe: Pretransplant and posttransplant (Month 12)Population: Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
CD8+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD8+ cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010 The change from baseline is defined as posttransplant TREC/100,000 CD8+ cells minus pretransplant TREC /100,000 CD8+ cells.
Outcome measures
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=9 Participants
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=7 Participants
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Mean Change From Baseline in TREC Per 100,000 CD8+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant
Baseline mean for TREC per 100,000 CD8+ cells
|
181.673 TREC /100,000 CD8+ cells
Standard Deviation 209.7599
|
364.414 TREC /100,000 CD8+ cells
Standard Deviation 280.3465
|
|
Mean Change From Baseline in TREC Per 100,000 CD8+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant
Mean change in TREC from baseline to final visit
|
-10.811 TREC /100,000 CD8+ cells
Standard Deviation 343.061
|
-184.084 TREC /100,000 CD8+ cells
Standard Deviation 282.405
|
Adverse Events
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
Placebo
Serious adverse events
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=12 participants at risk
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=13 participants at risk
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Pyrexia
|
8.3%
1/12
|
0.00%
0/13
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12
|
0.00%
0/13
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12
|
7.7%
1/13
|
|
Infections and infestations
Pneumonia mycoplasmal
|
8.3%
1/12
|
0.00%
0/13
|
|
Infections and infestations
Respiratory tract infection bacterial
|
8.3%
1/12
|
0.00%
0/13
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/12
|
7.7%
1/13
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.00%
0/12
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/12
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/12
|
7.7%
1/13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/12
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12
|
0.00%
0/13
|
|
Vascular disorders
Deep vein thrombosis
|
8.3%
1/12
|
0.00%
0/13
|
Other adverse events
| Measure |
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
n=12 participants at risk
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
|
Placebo
n=13 participants at risk
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/12
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12
|
7.7%
1/13
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12
|
0.00%
0/13
|
|
Endocrine disorders
Hypogonadism
|
8.3%
1/12
|
0.00%
0/13
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
7.7%
1/13
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12
|
7.7%
1/13
|
|
Gastrointestinal disorders
Food poisoning
|
8.3%
1/12
|
0.00%
0/13
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Axillary pain
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Fatigue
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Injection site swelling
|
8.3%
1/12
|
0.00%
0/13
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Edema peripheral
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Pyrexia
|
0.00%
0/12
|
15.4%
2/13
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12
|
7.7%
1/13
|
|
Infections and infestations
Central line infection
|
0.00%
0/12
|
7.7%
1/13
|
|
Infections and infestations
Herpes zoster
|
8.3%
1/12
|
0.00%
0/13
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12
|
7.7%
1/13
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12
|
7.7%
1/13
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12
|
0.00%
0/13
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12
|
7.7%
1/13
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12
|
7.7%
1/13
|
|
Investigations
Blood creatinine increased
|
8.3%
1/12
|
7.7%
1/13
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/12
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/12
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/12
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/12
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
15.4%
2/13
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
8.3%
1/12
|
0.00%
0/13
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
8.3%
1/12
|
0.00%
0/13
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12
|
7.7%
1/13
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
7.7%
1/13
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/12
|
7.7%
1/13
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/12
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12
|
15.4%
2/13
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.3%
1/12
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/12
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
0.00%
0/12
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
8.3%
1/12
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
|
7.7%
1/13
|
|
Vascular disorders
Hypertension
|
0.00%
0/12
|
7.7%
1/13
|
Additional Information
Global Medical Services
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER