Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

T cells administered by intravenous infusion after patient received transplant.

Source null

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primary · POSTED

GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1.

Source null

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secondary · POSTED

Detection of cytokine secretion was done by enzyme-linked immunosorbent assay.

This outcome measure was not done. Data was not collected for this outcome measure due to premature closure of study.

→

secondary · POSTED

Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease.

Source null

→

secondary · POSTED

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Source null

→

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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id: NCT00074490
trial label: Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0000
source section id
NCT00074490-om-0000
source outcome index
0
endpoint
Percentage of Patients to Receive T Cell Infusion
endpoint definition
T cells administered by intravenous infusion after patient received transplant.
time origin
first 100 days post-transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0001
source section id
NCT00074490-om-0001
source outcome index
1
endpoint
Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)
endpoint definition
GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1.
time origin
first 100 days post-transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0002
source section id
NCT00074490-om-0002
source outcome index
2
endpoint
Detection of of Post-transplantation Cluster of Differentiation 4 (CD4)+ and CD8+ T-cell Production of T Helper 1 -2 (Th1-Th2)-Type Cytokines
endpoint definition
Detection of cytokine secretion was done by enzyme-linked immunosorbent assay.
time origin
First 100 days post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This outcome measure was not done. Data was not collected for this outcome measure due to premature closure of 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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0003
source section id
NCT00074490-om-0003
source outcome index
3
endpoint
Percentage of Patients With Opportunistic Infection
endpoint definition
Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease.
time origin
First 100 days post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0004
source section id
NCT00074490-om-0004
source outcome index
4
endpoint
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
endpoint definition
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
time origin
Date treatment consent signed to date off study, approximately 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0000
arm key
OG000
arm label
Arm IVD Cohort 1 (Th2 DLI)
regimen
Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0000
arm key
OG001
arm label
Arm IVD Cohort 3 (Multiple Th2 DLI)
regimen
Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0000
arm key
OG002
arm label
Arm IVA (12-day Expanded Th2 DLI)
regimen
Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0000
arm key
OG003
arm label
Arm IVB (6-day Expanded Th2 DLI)
regimen
Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0000
arm key
OG004
arm label
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
regimen
Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0001
arm key
OG000
arm label
Arm IVD Cohort 1 (Th2 DLI)
regimen
Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0001
arm key
OG001
arm label
Arm IVD Cohort 3 (Multiple Th2 DLI)
regimen
Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0001
arm key
OG002
arm label
Arm IVA (12-day Expanded Th2 DLI)
regimen
Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0001
arm key
OG003
arm label
Arm IVB (6-day Expanded Th2 DLI)
regimen
Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0001
arm key
OG004
arm label
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
regimen
Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0002
arm key
OG000
arm label
Arm IVD Cohort 1 (Th2 DLI)
regimen
Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
outcome key
om-0002
arm key
OG001
arm label
Arm IVD Cohort 3 (Multiple Th2 DLI)
regimen
Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00074490-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
harm key
EG000
source section id
NCT00074490-ae
event group key
EG000
event group label
Arm IVD Cohort 1 (Th2 DLI)
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 5 years.
event definition
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
harm key
EG001
source section id
NCT00074490-ae
event group key
EG001
event group label
Arm IVD Cohort 3 (Multiple Th2 DLI)
serious affected
22
serious at risk
34
other affected
28
other at risk
34
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 5 years.
event definition
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
harm key
EG002
source section id
NCT00074490-ae
event group key
EG002
event group label
Arm IVA (12-day Expanded Th2 DLI)
serious affected
37
serious at risk
40
other affected
40
other at risk
40
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 5 years.
event definition
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
harm key
EG003
source section id
NCT00074490-ae
event group key
EG003
event group label
Arm IVB (6-day Expanded Th2 DLI)
serious affected
35
serious at risk
44
other affected
38
other at risk
44
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 5 years.
event definition
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
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-myelodysplastic-syndromes-tibsovo-05f0f33e
nct id
NCT00074490
harm key
EG004
source section id
NCT00074490-ae
event group key
EG004
event group label
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
serious affected
31
serious at risk
45
other affected
36
other at risk
45
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 5 years.
event definition
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
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