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| Name | Class |
|---|---|
| Norwood Immunology Limited | UNKNOWN |
| M.D. Anderson Cancer Center | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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Phase 2 study, conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation.
This Phase 2 study will be conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation. Patients will be randomized to receive either LAD 11.25 mg 3 Month treatment or placebo and all patients will be vaccinated with KLH 6 months posttransplant. Patients will be evaluated to determine if the rate of immunologic recovery in the LAD group is enhanced compared with the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAD 11.25 mg 3 Month Depot | Experimental | Three intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart. |
|
| Placebo Comparator | Placebo Comparator | Three intramuscular injections of matched placebo administered approximately 3 months apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide acetate depot (LAD) 11.25 mg 3 Month | Drug | LAD intramuscular injection 11.25 mg, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Month 6 prevaccination (baseline) and Month 7 postvaccination |
| 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 | 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. | Month 6 prevaccination (baseline) and Month 7 postvaccination |
| 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 | 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. | Month 6 prevaccination (baseline) and Month 7 postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Must be female between the ages of 18 - 50 or if female > 50 years old have an estradiol concentration level >= 30 pg/mL and follicle stimulating hormone level < 40 mIU/mL, or male between the ages of 18-65 (inclusive).
Must have Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma and be considered an appropriate candidate for hematopoietic stem cell transplant.
Must be seronegative for hepatitis C and HIV.
Must have received prior tetanus immunization
Must not have received prior KLH immunization.
Must have an ECOG performance status (PS) <= 1 or Karnofsky PS >= 70%.
Must have creatinine <= 2.0 mg/dL; ejection fraction > 45%; carbon monoxide diffusion in the lungs (DLCO) > 50% of predicted; serum bilirubin < 1.5 times the upper limit of normal unless Gilbert's syndrome, SGPT < 3 times normal value.
Must be more than 3 weeks from any prior surgery (except for central line placement) and have fully recovered from the effects of surgery.
Must have an absolute neutrophil count (ANC) >= 1,500 µL, platelet count >= 100,000/µL and hemoglobin >= 8.0 gm/dL within 21 days prior to randomization.
Must be able to return to the clinical site for follow-up visits.
Must be able to provide written consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Louis | Missouri | 63110 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo | Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Matched placebo | Drug | Matched placebo intramuscular injection, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6. |
|
| Pretransplant and posttransplant (Month 12) |
| 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 | 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. | Pretransplant and posttransplant (Month 12) |
| New York |
| New York |
| 10021 |
| United States |
| Durham | North Carolina | 27710 | United States |
| Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo | Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | mcg/mL | Month 6 prevaccination (baseline) and Month 7 postvaccination |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | TREC /100,000 CD4+ cells | Pretransplant and posttransplant (Month 12) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | TREC /100,000 CD8+ cells | Pretransplant and posttransplant (Month 12) |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | mcg/mL | Month 6 prevaccination (baseline) and Month 7 postvaccination |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | spots/1 million cells | Month 6 prevaccination (baseline) and Month 7 postvaccination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 6 | 12 | 7 | 12 | ||
| EG001 | Placebo | Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months. | 4 | 13 | 7 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) |
| ||
| Pyrexia | General disorders | MedDRA 11.1 |
| ||
| Gastroenteritis | Infections and infestations | MedDRA 11.1 |
| ||
| Pneumonia | Infections and infestations | MedDRA 11.1 |
| ||
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 11.1 |
| ||
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 11.1 |
| ||
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.1 |
| ||
| Staphylococcal bacteremia | Infections and infestations | MedDRA 11.1 |
| ||
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 11.1 |
| ||
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 11.1 |
| ||
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
| ||
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (11.1) |
| ||
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) |
| ||
| Palpitations | Cardiac disorders | MedDRA (11.1) |
| ||
| Hypogonadism | Endocrine disorders | MedDRA (11.1) |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
| ||
| Diarrhea | Gastrointestinal disorders | MedDRA 11.1 |
| ||
| Food poisoning | Gastrointestinal disorders | MedDRA 11.1 |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 |
| ||
| Axillary pain | General disorders | MedDRA 11.1 |
| ||
| Fatigue | General disorders | MedDRA 11.1 |
| ||
| Injection site swelling | General disorders | MedDRA 11.1 |
| ||
| Mucosal inflammation | General disorders | MedDRA 11.1 |
| ||
| Edema peripheral | General disorders | MedDRA 11.1 |
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| Pyrexia | General disorders | MedDRA 11.1 |
| ||
| Bronchitis | Infections and infestations | MedDRA 11.1 |
| ||
| Central line infection | Infections and infestations |
| |||
| Herpes zoster | Infections and infestations | MedDRA 11.1 |
| ||
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA 11.1 |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 |
| ||
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 |
| ||
| Blood creatinine increased | Investigations | MedDRA 11.1 |
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| Hemoglobin decreased | Investigations | MedDRA 11.1 |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 11.1 |
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| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 11.1 |
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| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 11.1 |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 11.1 |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA 11.1 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Dizziness | Nervous system disorders | MedDRA 11.1 |
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| Headache | Nervous system disorders | MedDRA 11.1 |
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| Anxiety | Psychiatric disorders | MedDRA 11.1 |
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| Insomnia | Psychiatric disorders | MedDRA 11.1 |
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| Mental status changes | Psychiatric disorders | MedDRA 11.1 |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 11.1 |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
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| Hypertension | Vascular disorders | MedDRA 11.1 |
|
The study was terminated early because of slow enrollment. For the primary endpoint, changes from baseline within each treatment group were analyzed. Between treatment group comparisons were not performed because the sample size was too small.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| >=65 years |
|
| Male |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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