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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation

Overview

Status
Terminated
Phase
Phase 2
Enrollment
25 participants (actual)
Sponsor
Abbott · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Feb 2006
Primary completion
Feb 2009
Completion
Not stated
First posted
11 Jan 2006 (estimated)
Last update posted
6 May 2010 (estimated)
Conditions
Hodgkin Disease · Lymphoma, Non-Hodgkin · Multiple Myeloma · Mantle Cell Lymphoma

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007200820092010
  1. Ph 2

    A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation

    NCT00275262

    Feb 2006 to Feb 2009 (primary)

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Leuprolide acetate depot (LAD) 11.25 mg 3 MonthDrug
  • Matched placeboDrug

Arms2

  • Experimental

    LAD 11.25 mg 3 Month Depot

    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.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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

    Time frame · Month 6 prevaccination (baseline) and Month 7 postvaccination

    Registry description

    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.

  2. 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

    Time frame · Month 6 prevaccination (baseline) and Month 7 postvaccination

    Registry description

    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.

  3. 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

    Time frame · Month 6 prevaccination (baseline) and Month 7 postvaccination

    Registry description

    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.

Secondary outcomes(2)
  1. 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

    Time frame · Pretransplant and posttransplant (Month 12)

    Registry description

    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.

  2. 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

    Time frame · Pretransplant and posttransplant (Month 12)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Month 6 prevaccination (baseline) and Month 7 postvaccination

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

GroupValue (mcg/mL)Spread
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month4.03.8
Placebo3.02.8
Primary outcomeMean· 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

GroupValue (mcg/mL)Spread
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month8.69.1
Placebo10.811.6
Primary outcomeMean· 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

GroupValue (spots/1 million cells)Spread
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month0.23.2
Placebo-1.43.2
Secondary and other outcome results(2)
Secondary outcomeMean· Pretransplant and posttransplant (Month 12)

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

GroupValue (TREC /100,000 CD4+ cells)Spread
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month67.52447.0863
Placebo173.712206.1733
Secondary outcomeMean· 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

GroupValue (TREC /100,000 CD8+ cells)Spread
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month181.673209.7599
Placebo364.414280.3465

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Leuprolide Acetate Depot (LAD) 11.25 mg 3 MonthPatients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.–6 / 127 / 12
PlaceboPatients received 1 injection of placebo every 3 months for a total treatment period of 9 months.–4 / 137 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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). 2. 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. 1. Multiple myeloma patients should have had a partial or complete response to chemotherapy. 2. Patients with Hodgkin's disease or non-Hodgkin's lymphoma who achieve a partial response to initial chemotherapy or first or second chemosensitive relapse, achieving a complete or partial response to salvage treatment. Patients in first remission with mantle cell lymphoma, or with intermediate or high grade lymphoma, presenting with high intermediate or high IPI (International Prognostic Index) scores are also eligible. 3. Must be seronegative for hepatitis C and HIV. 4. Must have received prior tetanus immunization 5. Must not have received prior KLH immunization. 6. Must have an ECOG performance status (PS) \<= 1 or Karnofsky PS \>= 70%. 7. 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. 8. Must be more than 3 weeks from any prior surgery (except for central line placement) and have fully recovered from the effects of surgery. 9. 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. 10. Must be able to return to the clinical site for follow-up visits. 11. Must be able to provide written consent. Exclusion Criteria: 1. Must not have an uncontrolled life-threatening infection (or active infectious process requiring intravenous \[IV\] systemic medical therapy within 1 week prior to study enrollment). 2. Must not have a diagnosed or suspected schistosomiasis infection. 3. Must not have previously received hematopoietic stem cell transplantation. 4. Must not require a tandem transplant. 5. Must not be female with a positive pregnancy test, pregnant, or lactating and breast feeding, or wish to become pregnant during the course of the study. Must agree to use barrier method of contraception. 6. Must not be receiving estrogen or testosterone replacement therapy,phytoestrogen, phyto-testosterone, or oral contraceptives (patients may enroll if oral contraceptives are ceased prior to study entry), or have been administered Depo Provera within 3 months of entering the study. 7. Must not have had prior mediastinal or sternal radiation. 8. Must not have received any investigational drug other than antibiotics within 3 weeks prior to study drug administration or are scheduled to receive an investigational drug during the course of this study. 9. Must not have unstable cardiac arrhythmias, uncontrolled congestive heart failure, history of myocardial infarction (MI) or ischemia, stroke, or embolic events within 6 months before study start. 10. Must not have medical or psychiatric conditions that, in the opinion of the investigator, would compromise the patient's ability to participate in the study. 11. Must not be receiving or plan to receive palifermin (KGF). 12. Must not have a allergy to shellfish. 13. Must not have previously taken a GnRH analog within 18 months. 14. Must not be a woman who has undergone bilateral oophorectomy, or man with orchiectomy.

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