TriangleNCT00112593 · STUDY IN CONTEXT
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without 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
Death From Regimen Toxicity or Opportunistic Infection
Death From GVHD
Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.
Kaplan-Meier estimate assessed at 1 year.
Count of participants with HIV progression.
Reconstitution of HIV-specific Immunity
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
- NCT00112593
- trial label
- Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without 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
- 6
- 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
- NCT00112593
- outcome key
- om-0000
- source section id
- NCT00112593-om-0000
- source outcome index
- 0
- endpoint
- Death From Regimen Toxicity or Opportunistic Infection
- endpoint definition
- Death From Regimen Toxicity or Opportunistic Infection
- time origin
- Within the first 100 days
- 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0001
- source section id
- NCT00112593-om-0001
- source outcome index
- 1
- endpoint
- Death From GVHD
- endpoint definition
- Death From GVHD
- time origin
- Within the first 360 days
- 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0002
- source section id
- NCT00112593-om-0002
- source outcome index
- 2
- endpoint
- Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin
- endpoint definition
- Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.
- time origin
- Up to day 80
- 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0003
- source section id
- NCT00112593-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival
- endpoint definition
- Kaplan-Meier estimate assessed at 1 year.
- time origin
- Up to 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0004
- source section id
- NCT00112593-om-0004
- source outcome index
- 4
- endpoint
- Progression of HIV
- endpoint definition
- Count of participants with HIV progression.
- time origin
- Within 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0005
- source section id
- NCT00112593-om-0005
- source outcome index
- 5
- endpoint
- Reconstitution of HIV-specific Immunity
- endpoint definition
- Reconstitution of HIV-specific Immunity
- time origin
- Up to 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-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
- regimen
- CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112593-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
- regimen
- CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112593-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
- regimen
- CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112593-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
- regimen
- CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112593-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
- regimen
- CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112593-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
- regimen
- CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112593-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT00112593
- harm key
- EG000
- source section id
- NCT00112593-ae
- event group key
- EG000
- event group label
- Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
- serious affected
- 0
- serious at risk
- 5
- other affected
- 0
- other at risk
- 5
- 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