TriangleNCT00089011 · OUTCOME
Rates of Disease Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 years
What was measured
Relapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
Groups in this outcome
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
Arm II (Nonmyeloablative Conditioning With TBI)
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
| Group | Source count |
|---|---|
| Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 100 |
| Arm II (Nonmyeloablative Conditioning With TBI) | 50 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 41 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Nonmyeloablative Conditioning With TBI) | 33 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 33
- denoms
- counts
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 50
- units
- Participants
- description
- Relapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
- groups
- description
- Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
- id
- OG000
- title
- Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
- description
- Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
- id
- OG001
- title
- Arm II (Nonmyeloablative Conditioning With TBI)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Rates of Disease Progression
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice