Trial Outcomes & Findings for Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia (NCT NCT01319981)
NCT ID: NCT01319981
Last Updated: 2022-09-27
Results Overview
The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of \</=5% blasts in the bone marrow, with \>1x10\^9/L neutrophils, \>100x10\^9/L platelets in the perpherial blood, and no extramedullary disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
1 year
Results posted on
2022-09-27
Participant Flow
Recruitment Period: March 2013 to November 2020
Participant milestones
| Measure |
Hyper-CMAD + Rituximab
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Hyper-CMAD + Rituximab
n=15 Participants
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD
n=16 Participants
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
n=5 Participants
|
61 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of \</=5% blasts in the bone marrow, with \>1x10\^9/L neutrophils, \>100x10\^9/L platelets in the perpherial blood, and no extramedullary disease.
Outcome measures
| Measure |
Hyper-CMAD + Rituximab
n=15 Participants
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD
n=16 Participants
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
|---|---|---|
|
Number of Patients With Complete Remission at One Year
|
12 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to 7 years, 8 monthsPopulation: Median not reached due to insufficient number of participants with events.
Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
Outcome measures
| Measure |
Hyper-CMAD + Rituximab
n=15 Participants
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD
n=16 Participants
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
|---|---|---|
|
Overall Survival
|
NA Months
Interval 0.3 to 92.0
Median not reached due to insufficient number of participants with events.
|
NA Months
Interval 4.4 to 92.0
Median not reached due to insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: Up to 7 years, 8 monthsPopulation: Of the 15 participants in the Hyper-CMAD + Rituximab arm, only 14 responded and are evaluable for Complete Remission Duration (CRD).
The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of \</=5% blasts in the bone marrow, with \>1x10\^9/L neutrophils, \>100x10\^9/L platelets in the perpherial blood, and no extramedullary disease. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis..
Outcome measures
| Measure |
Hyper-CMAD + Rituximab
n=14 Participants
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD
n=16 Participants
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
|---|---|---|
|
Complete Response Duration
|
NA Months
Interval 6.6 to 92.0
Median not reached due to insufficient number of participants.
|
NA Months
Interval 3.4 to 92.0
Median not reached due to insufficient number of participants.
|
Adverse Events
Hyper-CMAD + Rituximab ALL Ph -
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Hyper-CMAD + Rituximab ALL Ph +
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Hyper-CMAD ALL Ph +
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Hyper-CMAD ALL Ph -
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hyper-CMAD + Rituximab ALL Ph -
n=4 participants at risk
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD + Rituximab ALL Ph +
n=11 participants at risk
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD ALL Ph +
n=10 participants at risk
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
Hyper-CMAD ALL Ph -
n=6 participants at risk
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Up to 7 years
|
18.2%
2/11 • Number of events 2 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
25.0%
1/4 • Number of events 2 • Up to 7 years
|
18.2%
2/11 • Number of events 3 • Up to 7 years
|
20.0%
2/10 • Number of events 2 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
General disorders
Fever
|
50.0%
2/4 • Number of events 4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder other
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
30.0%
3/10 • Number of events 3 • Up to 7 years
|
33.3%
2/6 • Number of events 2 • Up to 7 years
|
|
General disorders
Infusion Related Reaction
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Lung Infection
|
50.0%
2/4 • Number of events 2 • Up to 7 years
|
27.3%
3/11 • Number of events 6 • Up to 7 years
|
20.0%
2/10 • Number of events 2 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Meningitis
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
General disorders
Pain
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
General disorders
Pain in Extremity
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
27.3%
3/11 • Number of events 5 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Small Intestine Infection
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Infections and infestations
Urinary Tract Infection
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
18.2%
2/11 • Number of events 6 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Skin Infection
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
General disorders
Abdominal Pain
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
20.0%
2/10 • Number of events 2 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
30.0%
3/10 • Number of events 4 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
General disorders
Back Pain
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 2 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
Other adverse events
| Measure |
Hyper-CMAD + Rituximab ALL Ph -
n=4 participants at risk
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD + Rituximab ALL Ph +
n=11 participants at risk
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
|
Hyper-CMAD ALL Ph +
n=10 participants at risk
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
Hyper-CMAD ALL Ph -
n=6 participants at risk
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
|
|---|---|---|---|---|
|
General disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Eye disorders
Conjunctivitis
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 3 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 2 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Gastroesophageal Refulx Disease
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
General disorders
Headache
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
18.2%
2/11 • Number of events 2 • Up to 7 years
|
30.0%
3/10 • Number of events 3 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 2 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 2 • Up to 7 years
|
|
Investigations
Elevated Prothrombin Time
|
0.00%
0/4 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Oral Mucositis
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
10.0%
1/10 • Number of events 1 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Up to 7 years
|
18.2%
2/11 • Number of events 2 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
50.0%
2/4 • Number of events 2 • Up to 7 years
|
18.2%
2/11 • Number of events 2 • Up to 7 years
|
20.0%
2/10 • Number of events 2 • Up to 7 years
|
16.7%
1/6 • Number of events 1 • Up to 7 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
50.0%
2/4 • Number of events 2 • Up to 7 years
|
45.5%
5/11 • Number of events 5 • Up to 7 years
|
50.0%
5/10 • Number of events 5 • Up to 7 years
|
66.7%
4/6 • Number of events 4 • Up to 7 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 7 years
|
9.1%
1/11 • Number of events 1 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Number of events 1 • Up to 7 years
|
0.00%
0/11 • Up to 7 years
|
0.00%
0/10 • Up to 7 years
|
0.00%
0/6 • Up to 7 years
|
Additional Information
Elias Joseph Jabbour, MD./ Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-4764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place