NCT00589602 · STUDY IN CONTEXT

T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases

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

The complication rate in matched unrelated donor (MUD) allogeneic bone marrow transplant (allo BMT) is known to be high. Graft failure and severe graft versus host disease (GvHD) are the most significant contributors to treatment related mortality (TRM). This treatment regimen will be considered unacceptable if the number of patients that experience TRM is 55% or greater, and effective if TRM is 33% or less.

Patients that received treatment

→

secondary · POSTED

The Rate of Acute Graft Versus Host Disease (GVHD)

Source null

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secondary · POSTED

Number of Participants With Duration of Absolute Neutropenia

Source null

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secondary · POSTED

Patients receive defined doses of donor T cells by IV infusion on days 45 and 100, in absence of active graft-versus-host disease (GVHD) requiring steroids.

Source null

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secondary · POSTED

number of patients that were still alive and relapse free

All patients that received treatment

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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-plasma-cell-neoplasms
nct id: NCT00589602
trial label: T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases
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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0000
source section id
NCT00589602-om-0000
source outcome index
0
endpoint
Treatment-related Mortality (TRM)
endpoint definition
The complication rate in matched unrelated donor (MUD) allogeneic bone marrow transplant (allo BMT) is known to be high. Graft failure and severe graft versus host disease (GvHD) are the most significant contributors to treatment related mortality (TRM). This treatment regimen will be considered unacceptable if the number of patients that experience TRM is 55% or greater, and effective if TRM is 33% or less.
time origin
180 days after transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients that received treatment
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-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0001
source section id
NCT00589602-om-0001
source outcome index
1
endpoint
The Rate of Acute Graft Versus Host Disease (GVHD)
endpoint definition
The Rate of Acute Graft Versus Host Disease (GVHD)
time origin
D+100 from 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-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0002
source section id
NCT00589602-om-0002
source outcome index
2
endpoint
Number of Participants With Duration of Absolute Neutropenia
endpoint definition
Number of Participants With Duration of Absolute Neutropenia
time origin
D+100 from 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-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0003
source section id
NCT00589602-om-0003
source outcome index
3
endpoint
Number of Participants Able to Receive T-cell Add Backs
endpoint definition
Patients receive defined doses of donor T cells by IV infusion on days 45 and 100, in absence of active graft-versus-host disease (GVHD) requiring steroids.
time origin
through D+100
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-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0004
source section id
NCT00589602-om-0004
source outcome index
4
endpoint
Number of Participants With Relapse-free Survival
endpoint definition
number of patients that were still alive and relapse free
time origin
after 7 years of follow up
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients that received treatment
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-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0000
arm key
OG000
arm label
T-Cell Depletion Transplant
regimen
Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT. Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation' peripheral blood lymphocyte therapy: T-cell depletion cyclophosphamide: T-cell depletion tacrolimus: T-cell depletion allogeneic hematopoietic stem cell transplantation: T-cell depletion peripheral blood stem cell transplantation: T-cell depletion total-body irradiation: T-cell depletion
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589602-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0001
arm key
OG000
arm label
T-Cell Depletion Transplant
regimen
Our protocol is designed to attempt to improve the current results of matched unrelated donor allogeneic bone marrow transplant (MUD allo BMT) and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT. Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; allogeneic hematopoietic stem cell transplantation; peripheral blood lymphocyte therapy: T-cell depletion cyclophosphamide: T-cell depletion tacrolimus: T-cell depletion allogeneic hematopoietic stem cell transplantation: T-cell depletion peripheral blood stem cell transplantation: T-cell depletion total-body irradiation: T-cell depletion
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589602-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0002
arm key
OG000
arm label
T-Cell Depletion Transplant
regimen
peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be \>0.5 x 105 but \<1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be \>2 x 106 cells/kg. cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day -5 and Day -4 tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589602-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0003
arm key
OG000
arm label
T-Cell Depletion Transplant
regimen
peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be \>0.5 x 105 but \<1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be \>2 x 106 cells/kg. cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day -5 and Day -4 tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589602-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00589602
outcome key
om-0004
arm key
OG000
arm label
T-Cell Depletion Transplant
regimen
peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be \>0.5 x 105 but \<1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be \>2 x 106 cells/kg. cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day -5 and Day -4 tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589602-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00589602
harm key
EG000
source section id
NCT00589602-ae
event group key
EG000
event group label
T-Cell Depletion Transplant
serious affected
9
serious at risk
12
other affected
12
other at risk
12
frequency threshold
0
collection period
Adverse events data was over the course of the study for approximately 7 years
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