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

Abbott

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Leuprolide acetate depot (LAD) 11.25 mg 3 Month; Drug: Matched placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00275262

L-BT04-093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

LAD 11.25 mg 3 Month Depot

Experimental group

Description:

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

Treatment:

Drug: Leuprolide acetate depot (LAD) 11.25 mg 3 Month

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Matched placebo