TriangleNCT00536601 · STUDY IN CONTEXT
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 recurrent 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
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
Toxicities will be reported using descriptive statistics.
Response rates will be reported using descriptive statistics.
Assessed using the product-limit based Kaplan Meier method.
Reported safety
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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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 recurrent 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- 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