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

NCT ID: NCT00275262

Last Updated: 2010-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Multiple Myeloma; Mantle Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LAD 11.25 mg 3 Month Depot

Three intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart.

Group Type: EXPERIMENTAL

Leuprolide acetate depot (LAD) 11.25 mg 3 Month

Intervention Type: 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.

Placebo Comparator

Three intramuscular injections of matched placebo administered approximately 3 months apart.

Group Type: PLACEBO_COMPARATOR

Matched placebo

Intervention Type: 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.

Interventions

Leuprolide acetate depot (LAD) 11.25 mg 3 Month

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.

Intervention Type: DRUG

Matched placebo

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.

Intervention Type: DRUG

Other Intervention Names

Lupron

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwood Immunology Limited

UNKNOWN

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Locations

St Louis, Missouri, United States

New York, New York, United States

Durham, North Carolina, United States

Houston, Texas, United States

Countries

United States

Other Identifiers

L-BT04-093

Identifier Type: -

Identifier Source: org_study_id