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← Acute Myeloid Leukemia

NCT00096161 · STUDY IN CONTEXT

Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant

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

A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements. "Chimerism" in hematopoietic cell transplant derives from this idea of a "mixed" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.

No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.

primary · POSTED

Clinical Stage of acute GVHD according to Organ System Skin: 1. \- Maculopapular rash \<25% of body surface 2. \- Maculopapular rash 25-50% of body surface 3. \- Maculopapular rash \>50% body surface area or generalized erythroderma 4. \- Generalized erythroderma with bullous formation and desquamation Liver: 1. \- Bilirubin 2-3 mg/dl 2. \- Bilirubin 3.1-6 mg/dl 3. \- Bilirubin 6.1-15 mg/dl 4. \- Bilirubin \>15 mg/dl Gut: 1. \- \>500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD 2. \- \>1000 -1500 mL diarrhea per day 3. \- \>1500 mL diarrhea per day 4. \- \>1500 mL diarrhea per day plus severe abdominal pain with or without ileus Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI

No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.

secondary · POSTED

Percentage patients with acute or chronic GVHD. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.

secondary · POSTED

Incidence of Infections

No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.

secondary · POSTED

CML Acquisition of a new cytogenetic abnormality and/or development of accelerated phase or blast crisis. Criteria for accelerated phase: unexplained fever \>38.3° C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, BM blasts and promyelocytes \>20%. AML, ALL, CMML \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL Progressive disease: ≥1 of: physical exam/imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ tx; or definite increase in the size/number of plasmacytomas or lytic bone lesions.

No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.

secondary · POSTED

Percentage patients surviving.

No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.

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-acute-myeloid-leukemia
nct id: NCT00096161
trial label: Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant
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: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0000
source section id
NCT00096161-om-0000
source outcome index
0
endpoint
Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism
endpoint definition
A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements. "Chimerism" in hematopoietic cell transplant derives from this idea of a "mixed" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.
time origin
From the time of enrollment maintained to day 56 after the last DLI, up to Day 112
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
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-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0001
source section id
NCT00096161-om-0001
source outcome index
1
endpoint
Incidence of Grade IV Acute GVHD
endpoint definition
Clinical Stage of acute GVHD according to Organ System Skin: 1. \- Maculopapular rash \<25% of body surface 2. \- Maculopapular rash 25-50% of body surface 3. \- Maculopapular rash \>50% body surface area or generalized erythroderma 4. \- Generalized erythroderma with bullous formation and desquamation Liver: 1. \- Bilirubin 2-3 mg/dl 2. \- Bilirubin 3.1-6 mg/dl 3. \- Bilirubin 6.1-15 mg/dl 4. \- Bilirubin \>15 mg/dl Gut: 1. \- \>500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD 2. \- \>1000 -1500 mL diarrhea per day 3. \- \>1500 mL diarrhea per day 4. \- \>1500 mL diarrhea per day plus severe abdominal pain with or without ileus Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI
time origin
Within 100 days after the last DLI
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
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-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0002
source section id
NCT00096161-om-0002
source outcome index
2
endpoint
Incidence of GVHD
endpoint definition
Percentage patients with acute or chronic GVHD. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
time origin
1 year after DLI
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
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-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0003
source section id
NCT00096161-om-0003
source outcome index
3
endpoint
Incidence of Infections
endpoint definition
Incidence of Infections
time origin
100 days after DLI
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
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-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0004
source section id
NCT00096161-om-0004
source outcome index
4
endpoint
Incidence of Relapse/Progression
endpoint definition
CML Acquisition of a new cytogenetic abnormality and/or development of accelerated phase or blast crisis. Criteria for accelerated phase: unexplained fever \>38.3° C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, BM blasts and promyelocytes \>20%. AML, ALL, CMML \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL Progressive disease: ≥1 of: physical exam/imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ tx; or definite increase in the size/number of plasmacytomas or lytic bone lesions.
time origin
1 year after DLI
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
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-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0005
source section id
NCT00096161-om-0005
source outcome index
5
endpoint
Survival
endpoint definition
Percentage patients surviving.
time origin
1 year after DLI
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
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-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0000
arm key
OG000
arm label
Group 1A (Pentostatin, DLI Dose Level 1)
regimen
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0000
arm key
OG001
arm label
Group 1B (Pentostatin, DLI Dose Level 2)
regimen
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0000
arm key
OG002
arm label
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
regimen
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0000
arm key
OG003
arm label
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
regimen
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0001
arm key
OG000
arm label
Group 1A (Pentostatin, DLI Dose Level 1)
regimen
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0001
arm key
OG001
arm label
Group 1B (Pentostatin, DLI Dose Level 2)
regimen
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0001
arm key
OG002
arm label
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
regimen
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0001
arm key
OG003
arm label
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
regimen
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0002
arm key
OG000
arm label
Group 1A (Pentostatin, DLI Dose Level 1)
regimen
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0002
arm key
OG001
arm label
Group 1B (Pentostatin, DLI Dose Level 2)
regimen
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0002
arm key
OG002
arm label
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
regimen
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
outcome key
om-0002
arm key
OG003
arm label
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
regimen
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00096161-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia
nct id
NCT00096161
harm key
EG000
source section id
NCT00096161-ae
event group key
EG000
event group label
Group 1A (Pentostatin, DLI Dose Level 1)
serious affected
6
serious at risk
20
other affected
10
other at risk
20
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
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-acute-myeloid-leukemia
nct id
NCT00096161
harm key
EG001
source section id
NCT00096161-ae
event group key
EG001
event group label
Group 1B (Pentostatin, DLI Dose Level 2)
serious affected
0
serious at risk
10
other affected
2
other at risk
10
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
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-acute-myeloid-leukemia
nct id
NCT00096161
harm key
EG002
source section id
NCT00096161-ae
event group key
EG002
event group label
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
serious affected
0
serious at risk
6
other affected
2
other at risk
6
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
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-acute-myeloid-leukemia
nct id
NCT00096161
harm key
EG003
source section id
NCT00096161-ae
event group key
EG003
event group label
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
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