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Study Summary
No. 2005-0244:.......Lymphoma; Myeloma......Richard E. Champlin......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2005-0244
Study Title:Leuprolide (Lupron, LHRH Agonist) to Enhance Immune Function Post-Autologous Stem Cell Transplantation
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Physician New Patient Referral
Name:Richard E. ChamplinPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:Lymphoma
Myeloma
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
every 3 months
Treatment
Agents:
Leuprolide AcetateHome Care:standard vaccinations and blood draws may be done by local physician if needed
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
none required for the study. Typically an autologous transplant patient will
be hospitalized 2-4 weeks as standard of care.
Description/
Intervention:
The goal of this clinical research study is to evaluate the effectiveness of
the drug leuprolide in improving the rate and quality of immune recovery for
people who receive high-dose chemotherapy following autologous hematopoietic
stem cell transplantation (HSCT). The effects of leuprolide on the recovery of
the immune system will be studied in people who have Hodgkin's disease,
non-Hodgkin's lymphoma, or multiple myeloma.
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Study Objectives / Outcomes
1. Assess the rate of immunologic recovery following high-dose chemotherapy and autologous stem cell transplantation as assessed by response to vaccination for patients receiving either 9 months of therapy with either Lupron Depot-3 Month 11.25 mg formulation or placebo.
2. Obtain safety data on the use of Lupron-3 Month 11.25 mg formulation for LHRH blockade as a means of enhancing immunologic recovery following myeloablative therapy and autologous stem cell transplantation.
3. Assess the rate of infection, disease relapse, and survival.
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Study Status Information
Study Activation / Registration Date:02/07/2006
IRB Review and Approval Date:06/01/2005
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:80
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) be females between the ages of 18 to 50 years (inclusive), or males between the ages of 18 to 65 years (inclusive)

2) have Hodgkin's disease, non-Hodgkin's lymphoma, or multiple myeloma, and be considered an appropriate candidate for HSCT: Multiple myeloma patients should have had a partial or complete response to chemotherapy. 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 with intermediate grade lymphoma in first remission, presenting with high intermediate or high IPI (International Prognostic Index) scores are also eligible.

3) be seronegative for hepatitis C and HIV

4) have received prior tetanus immunization.

5) have not received prior KLH immunization.

6) have an ECOG PS </= 1 or Karnofsky PS >/= 70%. (See Appendix F for the scale of Performance Status Criteria).

7) have creatinine </= 2.0 mg/dL; ejection fraction >45%; DLCO >50% of predicted; serum bilirubin <1.2 mg/dL, SGPT <3 times normal value

8) be more than 3 weeks from any prior surgery (except for central line placement) and have fully recovered from the effects of surgery

9) have an ANC >/=1,500 µL, platelet count >/=100,000/µL and hemoglobin >/=8.0 gm/dL within 21 days prior to randomization.

10) be able to return to clinic for follow-up visits

11) provide written consent

Exclusion Criteria:1) have uncontrolled life-threatening infection (or active infectious process requiring IV systemic medical therapy within one week prior to study enrollment).

2) have previously received HSCT.

3) are planning a tandem transplant.

4) are female with a positive pregnancy test, are pregnant, or lactating and breast-feeding, or wish to become pregnant during the course of the study. Patients unwilling to use a barrier method of contraception or who in the investigator's judgment would not be compliant in using an effective method of contraception will be excluded.

5) are receiving estrogen or testosterone replacement therapy, oral contraceptives (patients may enroll is oral contraceptives are ceased prior to study entry), or have been administered Depo Provera within 3 months of entering the study.

6) have had prior mediastinal or sternal radiation.

7) 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. Exceptions must be approved by the study chairman in writing and recorded in study records.

8) have unstable cardiac arrhythmias, uncontrolled congestive heart failure, history of MI or ischemia, stroke, or embolic events within 6 months before study start.

9) have medical or psychiatric conditions that, in the opinion of the investigator, would compromise the patient's ability to participate in the study.

10) are currently receiving corticosteroid therapy (in doses greater than hydrocortisone 50 mg). Patients are not eligible if they are receiving steroids at the time of study entry. After the patients are on study, they may receive steroid treatment if necessary, with the approval of the study chairman.

11) are or will be receiving palifermin (KGF).

12) have a Shellfish allergy.

13) have had a suspected or diagnosed schistosomiasis infection.

14) are currently or have previously taken a GNRH analog.

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Links
Registration Number: NCT00275262
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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