Trial Outcomes & Findings for Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System (NCT NCT01596127)
NCT ID: NCT01596127
Last Updated: 2018-05-24
Results Overview
The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
2 weeks
Results posted on
2018-05-24
Participant Flow
Recruitment: 1/24/2013 through 11/13/2013. All participants recruited at The University of Texas MD Anderson Cancer Center.
Four patients were enrolled and three participants were evaluable for safety and efficacy and toxicity. One patient was ineligible and therefore was never treated. Due to lack of response and slow accrual, the study was terminated early.
Participant milestones
| Measure |
Intrathecal Rituximab
Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.
Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.
Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Intrathecal Rituximab
Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.
Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.
Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.
|
|---|---|
|
Overall Study
Patient Ineligible
|
1
|
Baseline Characteristics
Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System
Baseline characteristics by cohort
| Measure |
Intrathecal Rituximab
n=4 Participants
Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.
Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.
Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.
|
|---|---|
|
Age, Continuous
|
38 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksThe percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.
Outcome measures
| Measure |
Intrathecal Rituximab
n=3 Participants
Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.
Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.
Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.
|
|---|---|
|
Response Rate
|
0 percentage of Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Multiple dose levels were designed with a starting dose of 10 mg per injection followed by 25 mg once safety was established in the first 3 patients treated at the first dose level. The study moved tot he next dose level. Due to lack of response and slow accrual, participants were never treated on the next dose level and the study was terminated
MTD is dose level at which at least 1 of 3 participants experiences a dose-limiting toxicity (DLT). DLTdefined as clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meeting the NCI common terminology criteria that are CTCAE Grade 3 or 4.
Outcome measures
Outcome data not reported
Adverse Events
Intrathecal Rituximab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intrathecal Rituximab
n=3 participants at risk
Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.
Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.
Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Multi-organ Failure
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
Other adverse events
| Measure |
Intrathecal Rituximab
n=3 participants at risk
Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.
Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.
Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Spasticity
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Hemorrhoids
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Renal and urinary disorders
Urinary Frequency
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
General disorders
Headache
|
100.0%
3/3 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Eye disorders
Eye disorder
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
|
Additional Information
Elias Jabbour MD/Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place