NCT00275262 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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 · POSTED

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.

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 · POSTED

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.

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.

→

secondary · POSTED

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.

Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. 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.

→

secondary · POSTED

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.

Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. 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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-mantle-cell-lymphoma
nct id: NCT00275262
trial label: A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0000
source section id
NCT00275262-om-0000
source outcome index
0
endpoint
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
endpoint definition
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.
time origin
Month 6 prevaccination (baseline) and Month 7 postvaccination
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0003
source section id
NCT00275262-om-0003
source outcome index
3
endpoint
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
endpoint definition
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.
time origin
Month 6 prevaccination (baseline) and Month 7 postvaccination
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0004
source section id
NCT00275262-om-0004
source outcome index
4
endpoint
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
endpoint definition
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.
time origin
Month 6 prevaccination (baseline) and Month 7 postvaccination
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0001
source section id
NCT00275262-om-0001
source outcome index
1
endpoint
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
endpoint definition
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.
time origin
Pretransplant and posttransplant (Month 12)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. 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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0002
source section id
NCT00275262-om-0002
source outcome index
2
endpoint
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
endpoint definition
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.
time origin
Pretransplant and posttransplant (Month 12)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. 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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0000
arm key
OG000
arm label
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
regimen
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0001
arm key
OG000
arm label
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
regimen
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0001
arm key
OG001
arm label
Placebo
regimen
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0002
arm key
OG000
arm label
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
regimen
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0002
arm key
OG001
arm label
Placebo
regimen
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0003
arm key
OG000
arm label
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
regimen
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0003
arm key
OG001
arm label
Placebo
regimen
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0004
arm key
OG000
arm label
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
regimen
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
outcome key
om-0004
arm key
OG001
arm label
Placebo
regimen
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00275262-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
harm key
EG000
source section id
NCT00275262-ae
event group key
EG000
event group label
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
serious affected
6
serious at risk
12
other affected
7
other at risk
12
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00275262
harm key
EG001
source section id
NCT00275262-ae
event group key
EG001
event group label
Placebo
serious affected
4
serious at risk
13
other affected
7
other at risk
13
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice