Trial Outcomes & Findings for Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma (NCT NCT00691652)

NCT ID: NCT00691652

Last Updated: 2019-11-27

Results Overview

Initially, 3 patients will be enrolled into a dose level during the dose-escalation portion: * If no patient experiences dose-limiting toxicities during the first 4 weeks, then 3 patients will be enrolled into the next dose level. * If one of the three patients develops dose-limiting toxicities, then 3 additional patients will be enrolled in that cohort. If none of the additional 3 patients experiences dose-limiting toxicities, then further dose-escalation occurs. * If one additional patient experiences dose-limiting toxicities, then the maximum tolerated dose is exceeded.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days
• Results posted on: 2019-11-27

Participant Flow

Participant milestones

Measure	Oral Clofarabine + Rituximab in Relapsed B Cell NHL Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off). Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg Phase II: Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	Oral Clofarabine + Rituximab in Relapsed B Cell NHL n=2 Participants Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off). Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg Phase II: Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	62.5 years STANDARD_DEVIATION 4.949 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days

Population: Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.

Initially, 3 patients will be enrolled into a dose level during the dose-escalation portion:

• If no patient experiences dose-limiting toxicities during the first 4 weeks, then 3 patients will be enrolled into the next dose level.
• If one of the three patients develops dose-limiting toxicities, then 3 additional patients will be enrolled in that cohort. If none of the additional 3 patients experiences dose-limiting toxicities, then further dose-escalation occurs.
• If one additional patient experiences dose-limiting toxicities, then the maximum tolerated dose is exceeded.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Oral Clofarabine x 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle

Population: Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year after study drug(s) have been given. Duration of study up to 1 year.

Population: Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of the study, up to 1 year.

Population: Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of the study, up to 1 year.

Population: Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of the study, up to 1 year.

Population: Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Twice monthly at standard of care visits for 3 months post last cycle of chemotherapy.

Population: Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.

Outcome measures

Outcome data not reported

Adverse Events

Oral Clofarabine + Rituximab in Relapsed B Cell NHL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Craig Okada

OHSU Knight Cancer Institute

Phone: 503-494-1080

Email: Okadac@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place