Trial Outcomes & Findings for Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia (NCT NCT01230788)
NCT ID: NCT01230788
Last Updated: 2014-12-01
Results Overview
To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.
TERMINATED
NA
1 participants
one year after enrollment
2014-12-01
Participant Flow
One participant recruited between September 2010 and June 2011 at Children's Healthcare of Atlanta.
Participant milestones
| Measure |
Rituximab Arm
375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Rituximab Arm
375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
|
|---|---|
|
Overall Study
Prescribed exclusion drug
|
1
|
Baseline Characteristics
Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Rituximab Arm
n=1 Participants
375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: one year after enrollmentPopulation: The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: two months after treatmentPopulation: The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
To describe the toxicities of rituximab in addition to prednisone, etoposide, and ifosfamide.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: one monthPopulation: The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
To estimate the remission induction rate of the addition of rituximab to cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one month after treatmentPopulation: The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
To perform serial minimal residual disease (MRD) measurements to provide an objective determination of the effectiveness of this therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one month after treatmentTo correlate the effect of prednisone on CD20 expression using serial measurements of CD20 expression in leukemic blasts.
Outcome measures
Outcome data not reported
Adverse Events
Rituximab Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place