TriangleNCT02556931 · STUDY IN CONTEXT
Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft 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
This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 90.
This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60.
Number of participants who experience grade III or IV acute GVHD between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
Number of participants who experience grade III or IV acute GVHD between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
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-prolymphocytic-leukemia
- nct id
- NCT02556931
- trial label
- Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft 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
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0000
- source section id
- NCT02556931-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort)
- endpoint definition
- This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 90.
- time origin
- Day 90
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety stopping criteria were not met after discontinuation of tacrolimus at day 90.
- 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-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0001
- source section id
- NCT02556931-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort)
- endpoint definition
- This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60.
- time origin
- Day 60
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 42 patients in the D60 cohort who stopped IS early as prespecified, 10 subsequently relapsed.
- 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-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0002
- source section id
- NCT02556931-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90)
- endpoint definition
- Number of participants who experience grade III or IV acute GVHD between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
- time origin
- Between Day 90 and Day 180
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 57 patients in the D90 cohort, 33 stopped tactolimus early as planned.
- 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-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0003
- source section id
- NCT02556931-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60)
- endpoint definition
- Number of participants who experience grade III or IV acute GVHD between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
- time origin
- Between Day 60 and Day 180
- 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-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0004
- source section id
- NCT02556931-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Chronic GVHD, Days 90-180 (D90)
- endpoint definition
- Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
- time origin
- Between Day 90 and Day 180
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned.
- 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-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0005
- source section id
- NCT02556931-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Chronic GVHD, Days 60-180 (D60)
- endpoint definition
- Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
- time origin
- Between Day 60 and Day 180
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned.
- 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-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0000
- arm key
- OG000
- arm label
- PBSCT D90
- regimen
- Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02556931-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0001
- arm key
- OG000
- arm label
- PBSCT D60
- regimen
- Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
- analyzed count
- 60
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02556931-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0002
- arm key
- OG000
- arm label
- PBSCT D90
- regimen
- Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02556931-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0003
- arm key
- OG000
- arm label
- PBSCT D60
- regimen
- Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02556931-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0004
- arm key
- OG000
- arm label
- PBSCT D90
- regimen
- Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02556931-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- outcome key
- om-0005
- arm key
- OG000
- arm label
- PBSCT D60
- regimen
- Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02556931-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- harm key
- EG000
- source section id
- NCT02556931-ae
- event group key
- EG000
- event group label
- PBSCT D90
- serious affected
- 9
- serious at risk
- 57
- other affected
- 35
- other at risk
- 57
- frequency threshold
- 0
- collection period
- adverse event data were collected for each particpant for at minimum 1 year. Median follow-up of 41 months in the D90 cohort and 27 months in the D60 cohort.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT02556931
- harm key
- EG001
- source section id
- NCT02556931-ae
- event group key
- EG001
- event group label
- PBSCT D60
- serious affected
- 5
- serious at risk
- 60
- other affected
- 16
- other at risk
- 60
- frequency threshold
- 0
- collection period
- adverse event data were collected for each particpant for at minimum 1 year. Median follow-up of 41 months in the D90 cohort and 27 months in the D60 cohort.
- 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