TriangleNCT01529827 · STUDY IN CONTEXT
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
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 transplant related mortality (TRM). An exact 95% confidence interval will be provided.
Patients will be followed according to response criteria as referenced in BMT SOP "Standards of Therapy" last updated 2008. Clinical Response = CR + PR. Complete Response Requires all of the following: * Serum and urine negative for monoclonal proteins by immunofixation * Normal free light chain ratio * Plasma cells in marrow \< 5% Partial Response (PR) Requires any of the following: \- ≥ 50% reduction in current serum monoclonal protein levels \> 0.5 g/dL or urine light chain levels \> 100 mg/day with a visible peak or free light chain levels \> 10mg/dL Progressive Disease (PD) Requires any of the following: * If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double) * If progressive from PR or SD, ≥ 50% increase in the serum M protein to \> 0.5 g/dL,or ≥ 50% increase in urine M protein to \> 200mg/day with visible peak present. * Free light chain increase of ≥ 50% to
Assessed using Kaplan Meier and Proportional Hazards
Median time to recovery of absolute neutrophil count \>=500/uL for 3 consecutive days. 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- trial label
- Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
- 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
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0000
- source section id
- NCT01529827-om-0000
- source outcome index
- 0
- endpoint
- Transplant Related Mortality (TRM)
- endpoint definition
- Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided.
- time origin
- In the first 100 days from day 0 of transplant
- 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0001
- source section id
- NCT01529827-om-0001
- source outcome index
- 1
- endpoint
- Clinical Response
- endpoint definition
- Patients will be followed according to response criteria as referenced in BMT SOP "Standards of Therapy" last updated 2008. Clinical Response = CR + PR. Complete Response Requires all of the following: * Serum and urine negative for monoclonal proteins by immunofixation * Normal free light chain ratio * Plasma cells in marrow \< 5% Partial Response (PR) Requires any of the following: \- ≥ 50% reduction in current serum monoclonal protein levels \> 0.5 g/dL or urine light chain levels \> 100 mg/day with a visible peak or free light chain levels \> 10mg/dL Progressive Disease (PD) Requires any of the following: * If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double) * If progressive from PR or SD, ≥ 50% increase in the serum M protein to \> 0.5 g/dL,or ≥ 50% increase in urine M protein to \> 200mg/day with visible peak present. * Free light chain increase of ≥ 50% to
- time origin
- In the first 100 days from day 0 of transplant
- 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0002
- source section id
- NCT01529827-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS) at One Year
- endpoint definition
- Assessed using Kaplan Meier and Proportional Hazards
- time origin
- day of transplant until progression up to 5 years
- 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0003
- source section id
- NCT01529827-om-0003
- source outcome index
- 3
- endpoint
- Median Time to Neutrophil Engraftment
- endpoint definition
- Median time to recovery of absolute neutrophil count \>=500/uL for 3 consecutive days. 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic PBSCT)
- regimen
- PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01529827-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic PBSCT)
- regimen
- PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01529827-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic PBSCT)
- regimen
- PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01529827-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Reduced Intensity Allogeneic PBSCT)
- regimen
- PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01529827-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01529827
- harm key
- EG000
- source section id
- NCT01529827-ae
- event group key
- EG000
- event group label
- Treatment (Reduced Intensity Allogeneic PBSCT)
- serious affected
- 17
- serious at risk
- 94
- other affected
- 1
- other at risk
- 94
- 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