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Leuprolide Acetate to Enhance Immune Function Post-Autologous Stem Cell Transplantation

Phase 2
18 Years
65 Years
Not Enrolling
Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Mantle Cell Lymphoma

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Trial Information

Leuprolide Acetate to Enhance Immune Function Post-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.

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

1. Multiple myeloma patients should have had a partial or complete response to

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

Month 6 prevaccination (baseline) and Month 7 postvaccination

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Hodgkin Disease
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Mantle Cell Lymphoma
  • Bone marrow transplantation
  • Hematopoietic stem cell transplantation
  • Hodgkin's disease
  • non-Hodgkin's lymphoma
  • multiple myeloma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Lymphoma, Mantle-Cell



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