Hodgkin DiseasePhase 2NCT00275262

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

A Phase 2 study testing Leuprolide acetate depot (LAD) 11.25 mg 3 Month in people with Hodgkin Disease and Lymphoma, Non-Hodgkin, run by Abbott at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma
What is being tested?: Leuprolide acetate depot (LAD) 11.25 mg 3 Month
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 4 sitesUnited States
Study dates: Feb 2006to Feb 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).
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.
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 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.
Must be seronegative for hepatitis C and HIV.
Must have received prior tetanus immunization

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Must not have received prior KLH immunization.
Must have an ECOG performance status (PS) <= 1 or Karnofsky PS >= 70%.
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.
Must be more than 3 weeks from any prior surgery (except for central line placement) and have fully recovered from the effects of surgery.
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.
Must be able to return to the clinical site for follow-up visits.
Must be able to provide written consent.

Who cannot join

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).
Must not have a diagnosed or suspected schistosomiasis infection.
Must not have previously received hematopoietic stem cell transplantation.
Must not require a tandem transplant.
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.
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.

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Must not have had prior mediastinal or sternal radiation.
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.
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.
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.
Must not be receiving or plan to receive palifermin (KGF).
Must not have a allergy to shellfish.
Must not have previously taken a GnRH analog within 18 months.
Must not be a woman who has undergone bilateral oophorectomy, or man with orchiectomy.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Durham, North Carolina, 27710
Study site
Houston, Texas, 77030
Study site
New York, New York, 10021
Study site
St Louis, Missouri, 63110

Other trials in United States

About this study

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

Read the 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
Being tested: Leuprolide acetate depot (LAD) 11.25 mg 3 Month, Matched placebo
Keywords: Bone marrow transplantation, Hematopoietic stem cell transplantation, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma
Medical subject headings: Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Leuprolide acetate depot (LAD) 11.25 mg 3 MonthDrug
Also called Lupron
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.
Matched placeboDrug
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.

Study groups in NCT00275262
Study group	Role	What they receive
LAD 11.25 mg 3 Month Depot	Experimental	Three intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart. Receives: Drug: Leuprolide acetate depot (LAD) 11.25 mg 3 Month
Placebo Comparator	Placebo comparator	Three intramuscular injections of matched placebo administered approximately 3 months apart. Receives: Drug: Matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Month 6 prevaccination (baseline) and Month 7 postvaccination

Secondary outcomes (2)

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
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.
Measured: 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
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.
Measured: Pretransplant and posttransplant (Month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Feb 2009

First posted11 Jan 2006 (estimated)
Study startFeb 2006
Primary completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00275262
Sponsor's protocol ID: L-BT04-093
Status last verified: Apr 2010
First submitted: 9 Jan 2006
Last updated: 6 May 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Leuprolide Acetate to Enhance Immune Function Post-Autologous Stem Cell Transplantation
ClinicalTrials.gov ID: NCT00275262
Acronym / sponsor ID: L-BT04-093
Conditions: Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Mantle Cell Lymphoma
Keywords: Bone marrow transplantation, Hematopoietic stem cell transplantation, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 25 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Norwood Immunology Limited, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute
Study start: Feb 2006
Primary completion: Feb 2009 (actual)
First posted: 11 Jan 2006 (estimated)
Results: Posted 6 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LAD 11.25 mg 3 Month Depot	Experimental	Drug: Leuprolide acetate depot (LAD) 11.25 mg 3 MonthThree intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart.
Placebo Comparator	Placebo comparator	Drug: Matched placeboThree intramuscular injections of matched placebo administered approximately 3 months apart.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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).
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.
Must be seronegative for hepatitis C and HIV.
Must have received prior tetanus immunization
Must not have received prior KLH immunization.

Key exclusion criteria (14 listed)

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).
Must not have a diagnosed or suspected schistosomiasis infection.
Must not have previously received hematopoietic stem cell transplantation.
Must not require a tandem transplant.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Leuprolide acetate depot (LAD) 11.25 mg 3 MonthAlso: LupronLAD 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.	Drug	LAD 11.25 mg 3 Month Depot
Matched placeboMatched 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.	Drug	Placebo Comparator

Primary outcome

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
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.
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
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.
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
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.

2 secondary outcomes

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)
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)

Results and safety

Results posted to the registry on 6 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month	12	6
Placebo	13	4

Primary outcome: 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. Mean (Standard Deviation). Unit: mcg/mL

Measure	Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month n = 8	Placebo n = 5
Mean IgM at baseline (mcg/mL)	4.0 (3.8)	3.0 (2.8)
Mean IgM change from baseline (mcg/mL)	2.91 (2.07)	0.57 (0.83)

Population analysed: Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Primary outcome: 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. Mean (Standard Deviation). Unit: mcg/mL

Measure	Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month n = 8	Placebo n = 5
Mean IgG1 at baseline (mcg/mL)	8.6 (9.1)	10.8 (11.6)
Mean IgG1 change from baseline (mcg/mL)	46.16 (44.01)	16.76 (28.15)

Population analysed: Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Primary outcome: 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. Mean (Standard Deviation). Unit: spots/1 million cells

Measure	Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month n = 6	Placebo n = 5
Mean interferon gamma at baseline	0.2 (3.2)	-1.4 (3.2)
Mean interferon gamma change from baseline	2.09 (4.85)	10.25 (11.41)

Population analysed: Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month	6 of 12 (50%)	7 of 12 (58.3%)	Not reported
Placebo	4 of 13 (30.8%)	7 of 13 (53.8%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early because of slow enrollment. For the primary endpoint, changes from baseline within each treatment group were analyzed. Between treatment group comparisons were not performed because the sample size was too small.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Leuprolide acetate depot (LAD) 11.25 mg 3 Month in people with Hodgkin Disease and Lymphoma, Non-Hodgkin, run by Abbott at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: Month 6 prevaccination (baseline) and Month 7 postvaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00275262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2010.