TriangleNCT01979536 · OUTCOME
Prognostic Significance of Minimal Residual Disease
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to progressive disease, relapse, or death, assessed up to 2 years
What was measured
Analyzed by estimating the 2-year EFS of negative MRD and positive MRD by arm. Minimal disease was performed using serial assessments of the t(2;5)(p23;q35) NPM-ALK fusion transcript using quantitative RT-PCR. Quantitative RT-PCR was performed by extracting total RNA from peripheral blood specimens. Peripheral blood samples were obtained at baseline, on day 1 of cycle 1, and on day 1 of cycle 2. The normalized copy numbers (NCN) were expressed as copy numbers of NPM-ALK per 104 copies of ABL. Minimal disease (MDD) was defined as \>10 NCN at baseline.
Analysis population: 11 Arm BV patients without adequate MDD baseline data, 1 Arm CZ patient who did not start treatment, and 11 Arm CZ patients without adequate MDD baseline data are excluded from these analyses.
Groups in this outcome
MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, dexamethasone orally (PO) twice daily (BID) or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.
MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, dexamethasone orally (PO) twice daily (BID) or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.
MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy)
COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy)
COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
| Group | Source count |
|---|---|
| MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 38 |
| MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 19 |
| MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) | 37 |
| MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 89 | Not reported | 73.1 | 95.7 | Not reported |
| MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 52.6 | Not reported | 28.7 | 71.9 | Not reported |
| MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) | 85.6 | Not reported | 68.6 | 93.8 | Not reported |
| MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) | 58.1 | Not reported | 33.4 | 76.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.1
- upper Limit
- 95.7
- value
- 89
- group Id
- OG001
- lower Limit
- 28.7
- upper Limit
- 71.9
- value
- 52.6
- group Id
- OG002
- lower Limit
- 68.6
- upper Limit
- 93.8
- value
- 85.6
- group Id
- OG003
- lower Limit
- 33.4
- upper Limit
- 76.4
- value
- 58.1
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 37
- group Id
- OG003
- value
- 20
- units
- Participants
- description
- Analyzed by estimating the 2-year EFS of negative MRD and positive MRD by arm. Minimal disease was performed using serial assessments of the t(2;5)(p23;q35) NPM-ALK fusion transcript using quantitative RT-PCR. Quantitative RT-PCR was performed by extracting total RNA from peripheral blood specimens. Peripheral blood samples were obtained at baseline, on day 1 of cycle 1, and on day 1 of cycle 2. The normalized copy numbers (NCN) were expressed as copy numbers of NPM-ALK per 104 copies of ABL. Minimal disease (MDD) was defined as \>10 NCN at baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, dexamethasone orally (PO) twice daily (BID) or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.
- id
- OG000
- title
- MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, dexamethasone orally (PO) twice daily (BID) or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.
- id
- OG001
- title
- MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
- id
- OG002
- title
- MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy)
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
- id
- OG003
- title
- MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy)
- param Type
- NUMBER
- population Description
- 11 Arm BV patients without adequate MDD baseline data, 1 Arm CZ patient who did not start treatment, and 11 Arm CZ patients without adequate MDD baseline data are excluded from these analyses.
- reporting Status
- POSTED
- time Frame
- Baseline up to progressive disease, relapse, or death, assessed up to 2 years
- title
- Prognostic Significance of Minimal Residual Disease
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
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Preserved source evidence · Not medical advice