TriangleNCT00856388 · STUDY IN CONTEXT
Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders
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
Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.
Median Time to ANC Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
Median Time to Platelet Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
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-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- trial label
- Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0000
- source section id
- NCT00856388-om-0000
- source outcome index
- 0
- endpoint
- Day 100 TRM
- endpoint definition
- Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.
- time origin
- First 100 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated and eligible patients
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0001
- source section id
- NCT00856388-om-0001
- source outcome index
- 1
- endpoint
- Median Time to ANC Engraftment
- endpoint definition
- Median Time to ANC Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
- time origin
- Days 30
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated and eligible patients
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0002
- source section id
- NCT00856388-om-0002
- source outcome index
- 2
- endpoint
- Median Time to Platelet Engraftment
- endpoint definition
- Median Time to Platelet Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
- time origin
- Day 100
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated and eligible patients
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0003
- source section id
- NCT00856388-om-0003
- source outcome index
- 3
- endpoint
- Rate of Complete Donor Chimerism - Blood
- endpoint definition
- Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
- time origin
- Day 30
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated and eligible patients, who were able to complete testing
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0004
- source section id
- NCT00856388-om-0004
- source outcome index
- 4
- endpoint
- Rate of Complete Donor Chimerism - Blood
- endpoint definition
- Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
- time origin
- Day 100
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated and eligible patients, who were able to complete testing
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0005
- source section id
- NCT00856388-om-0005
- source outcome index
- 5
- endpoint
- Acute GVHD Grade III-IV
- endpoint definition
- Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
- time origin
- Up to day 100
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated and eligible patients
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
- analyzed count
- 61
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00856388-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
- analyzed count
- 61
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00856388-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
- analyzed count
- 61
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00856388-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00856388-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
- analyzed count
- 49
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00856388-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
- analyzed count
- 61
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00856388-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00856388
- harm key
- EG000
- source section id
- NCT00856388-ae
- event group key
- EG000
- event group label
- Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
- serious affected
- 34
- serious at risk
- 62
- other affected
- 0
- other at risk
- 62
- frequency threshold
- 0
- 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