TriangleNCT00245037 · OUTCOME
Progression-Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of analyzed participants
- Interval / dispersion
- Not reported
- Time frame
- Years 1, 2, 3, and 5
What was measured
The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5. Definition of Disease Progression: MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%. CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells. AML/ALL: Any incidence of relapse (\>5% blasts) by evaluation of the bone marrow aspirate. CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by \>25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis. MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (\>5%) or worsening cytopenia or cytogenetic evidence of recurrence.
Groups in this outcome
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
| Group | Source count |
|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 147 |
Reported measurements
Year 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 48 | Not reported | Not reported | Not reported | Not reported |
Year 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 39 | Not reported | Not reported | Not reported | Not reported |
Year 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 35 | Not reported | Not reported | Not reported | Not reported |
Year 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 29 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 48
- title
- Year 1
- categories
- measurements
- group Id
- OG000
- value
- 39
- title
- Year 2
- categories
- measurements
- group Id
- OG000
- value
- 35
- title
- Year 3
- categories
- measurements
- group Id
- OG000
- value
- 29
- title
- Year 5
- denoms
- counts
- group Id
- OG000
- value
- 147
- units
- Participants
- description
- The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5. Definition of Disease Progression: MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%. CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells. AML/ALL: Any incidence of relapse (\>5% blasts) by evaluation of the bone marrow aspirate. CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by \>25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis. MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (\>5%) or worsening cytopenia or cytogenetic evidence of recurrence.
- groups
- description
- Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
- id
- OG000
- title
- Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Years 1, 2, 3, and 5
- title
- Progression-Free Survival
- type
- SECONDARY
- unit Of Measure
- percentage of analyzed participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice