High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

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

Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.

Each disease strata presents PFS for each conditioning regimen defined in the protocol

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secondary · POSTED

Toxicities will be reported using descriptive statistics.

Source null

→

secondary · POSTED

Response rates will be reported using descriptive statistics.

Source null

→

secondary · POSTED

Assessed using the product-limit based Kaplan Meier method.

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-acute-myeloid-leukemia-mylotarg-85925ef2
nct id: NCT00536601
trial label: High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
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: 4
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0000
source section id
NCT00536601-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
endpoint definition
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
time origin
From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Each disease strata presents PFS for each conditioning regimen defined in the protocol
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-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0001
source section id
NCT00536601-om-0001
source outcome index
1
endpoint
Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))
endpoint definition
Toxicities will be reported using descriptive statistics.
time origin
Up to 100 days after transplantation
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-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0002
source section id
NCT00536601-om-0002
source outcome index
2
endpoint
Response Rate (Complete Remission)
endpoint definition
Response rates will be reported using descriptive statistics.
time origin
At 100 days
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-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0003
source section id
NCT00536601-om-0003
source outcome index
3
endpoint
Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)
endpoint definition
Assessed using the product-limit based Kaplan Meier method.
time origin
Patients are followed up to maximum of 12 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-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0000
arm key
OG000
arm label
Acute Leukemia
regimen
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0000
arm key
OG001
arm label
Hodgkin Lymphoma
regimen
Patients diagnosed with and treated for Hodgkin Lymphoma
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0000
arm key
OG002
arm label
Non-Hodgkin Lymphoma
regimen
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0000
arm key
OG003
arm label
MM/Amyloid
regimen
Patients diagnosed with or treated for multiple myeloma or amyloidosis
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0000
arm key
OG004
arm label
Solid Tumors
regimen
Patients diagnosed with and treated for a solid tumor
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0001
arm key
OG000
arm label
Acute Leukemia
regimen
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0001
arm key
OG001
arm label
Hodgkin Lymphoma
regimen
Patients diagnosed with and treated for Hodgkin Lymphoma
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0001
arm key
OG002
arm label
Non-Hodgkin Lymphoma
regimen
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0001
arm key
OG003
arm label
MM/Amyloid
regimen
Patients diagnosed with or treated for multiple myeloma or amyloidosis
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0001
arm key
OG004
arm label
Solid Tumors
regimen
Patients diagnosed with and treated for a solid tumor
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0002
arm key
OG000
arm label
Acute Leukemia
regimen
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
outcome key
om-0002
arm key
OG001
arm label
Hodgkin Lymphoma
regimen
Patients diagnosed with and treated for Hodgkin Lymphoma
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00536601-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-mylotarg-85925ef2
nct id
NCT00536601
harm key
EG000
source section id
NCT00536601-ae
event group key
EG000
event group label
Acute Leukemia
serious affected
1
serious at risk
6
other affected
0
other at risk
6
frequency threshold
0
collection period
SAE= 100 days after transplantation All cause mortality = 12 years
event definition
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
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-mylotarg-85925ef2
nct id
NCT00536601
harm key
EG001
source section id
NCT00536601-ae
event group key
EG001
event group label
Hodgkin Lymphoma
serious affected
9
serious at risk
21
other affected
0
other at risk
21
frequency threshold
0
collection period
SAE= 100 days after transplantation All cause mortality = 12 years
event definition
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
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-mylotarg-85925ef2
nct id
NCT00536601
harm key
EG002
source section id
NCT00536601-ae
event group key
EG002
event group label
Non-Hodgkin Lymphoma
serious affected
19
serious at risk
71
other affected
0
other at risk
71
frequency threshold
0
collection period
SAE= 100 days after transplantation All cause mortality = 12 years
event definition
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
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-mylotarg-85925ef2
nct id
NCT00536601
harm key
EG003
source section id
NCT00536601-ae
event group key
EG003
event group label
MM/Amyloid
serious affected
31
serious at risk
65
other affected
0
other at risk
65
frequency threshold
0
collection period
SAE= 100 days after transplantation All cause mortality = 12 years
event definition
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
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-mylotarg-85925ef2
nct id
NCT00536601
harm key
EG004
source section id
NCT00536601-ae
event group key
EG004
event group label
Solid Tumors
serious affected
3
serious at risk
11
other affected
0
other at risk
11
frequency threshold
0
collection period
SAE= 100 days after transplantation All cause mortality = 12 years
event definition
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
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