NCT00049504 · STUDY IN CONTEXT
Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
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-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- trial label
- Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- outcome key
- om-0000
- source section id
- NCT00049504-om-0000
- source outcome index
- 0
- endpoint
- Donor Engraftment (Chimerism)
- endpoint definition
- Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population
- time origin
- At day +84 after transplantation
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients receiving haploidentical transplant who had T cell chimerism tested at day +84
- 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-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- outcome key
- om-0001
- source section id
- NCT00049504-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Grades III-IV Acute GVHD
- endpoint definition
- Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity
- time origin
- At any time within 200 days after transplantation
- 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-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- outcome key
- om-0002
- source section id
- NCT00049504-om-0002
- source outcome index
- 2
- endpoint
- Non-relapse-related Mortality
- endpoint definition
- Number of deaths without progression or recurrence of malignant disease
- time origin
- Up to 200 days after transplantation
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Nonmyeloablative HSCT)
- regimen
- NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35.
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00049504-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Nonmyeloablative HSCT)
- regimen
- NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00049504-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Nonmyeloablative HSCT)
- regimen
- NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00049504-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-truxima-09fad21d
- nct id
- NCT00049504
- harm key
- EG000
- source section id
- NCT00049504-ae
- event group key
- EG000
- event group label
- Treatment (Nonmyeloablative HSCT)
- serious affected
- 11
- serious at risk
- 55
- other affected
- 55
- other at risk
- 55
- 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
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