TriangleNCT00134004 · STUDY IN CONTEXT
Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
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
Percentage of participants who die for any reason other than recurrence of disease.
Percentage of participants who experience disease relapse.
Percentage of participants who do not experience disease relapse, disease progression, or death.
Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as \<5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.
Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.
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-myeloproliferative-neoplasms
- nct id
- NCT00134004
- trial label
- Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
- 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-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0000
- source section id
- NCT00134004-om-0000
- source outcome index
- 0
- endpoint
- Transplant-related Mortality
- endpoint definition
- Percentage of participants who die for any reason other than recurrence of disease.
- time origin
- Cumulative incidence for the entire study, up to 11 years
- 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-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0001
- source section id
- NCT00134004-om-0001
- source outcome index
- 1
- endpoint
- Relapse Rate
- endpoint definition
- Percentage of participants who experience disease relapse.
- time origin
- Cumulative incidence for the entire study, up to 11 years
- 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-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0002
- source section id
- NCT00134004-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- Percentage of participants who do not experience disease relapse, disease progression, or death.
- time origin
- 2 years
- 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-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0003
- source section id
- NCT00134004-om-0003
- source outcome index
- 3
- endpoint
- Graft Failure Rate
- endpoint definition
- Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as \<5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.
- time origin
- Cumulative incidence for the entire study, up to 11 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0004
- source section id
- NCT00134004-om-0004
- source outcome index
- 4
- endpoint
- Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation
- endpoint definition
- Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.
- time origin
- 1 year
- 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-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Mini-haplo BMT
- regimen
- Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
- analyzed count
- 210
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00134004-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Mini-haplo BMT
- regimen
- Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
- analyzed count
- 210
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00134004-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Mini-haplo BMT
- regimen
- Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
- analyzed count
- 210
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00134004-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Mini-haplo BMT
- regimen
- Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
- analyzed count
- 210
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00134004-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloproliferative-neoplasms
- nct id
- NCT00134004
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Mini-haplo BMT
- regimen
- Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
- analyzed count
- 210
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00134004-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloproliferative-neoplasms
- nct id
- NCT00134004
- harm key
- EG000
- source section id
- NCT00134004-ae
- event group key
- EG000
- event group label
- Mini-haplo BMT
- serious affected
- 20
- serious at risk
- 210
- other affected
- 11
- other at risk
- 210
- frequency threshold
- 5
- collection period
- Source null
- 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