Trial Outcomes & Findings for Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT00983528)

NCT ID: NCT00983528

Last Updated: 2020-08-12

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2020-08-12

Participant Flow

Study enrolled six participants, but no participants completed study. Study was terminated due to slow accrual. All study data is reported by all participants since no data was analyzed due to study termination.

Participant milestones

Measure	Alemtuzumab and Clofarabine Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Alemtuzumab and Clofarabine Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
Overall Study Death	4
Overall Study Lost to Follow-up	1
Overall Study Study Terminated	1

Baseline Characteristics

Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	Alemtuzumab and Clofarabine n=6 Participants Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
Age, Continuous	41.85 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 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

PRIMARY outcome

Timeframe: 2 years

Population: Study enrolled six participants, but all participants withdrew or expired while on the study and study was ultimately terminated. As a results the study data was not collected and analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Alemtuzumab and Clofarabine n=6 Participants Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
Number of Adverse Events Nose Bleed	1 adverse events
Number of Adverse Events Diarrhea	5 adverse events
Number of Adverse Events Nausea	6 adverse events
Number of Adverse Events Vomiting	6 adverse events
Number of Adverse Events Dyspesia	1 adverse events
Number of Adverse Events Fever	4 adverse events
Number of Adverse Events Constipation	5 adverse events
Number of Adverse Events Pain	6 adverse events
Number of Adverse Events Insomnia	6 adverse events
Number of Adverse Events Itching	4 adverse events
Number of Adverse Events Deaths	4 adverse events
Number of Adverse Events Anxiety	6 adverse events
Number of Adverse Events Rash	1 adverse events
Number of Adverse Events Hives	1 adverse events
Number of Adverse Events Dry Eyes	1 adverse events

Adverse Events

Alemtuzumab and Clofarabine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MCC Clinical Trials Office

UC San Diego

Phone: (858) 534-5417

Email: tkipps@ucsd.edu

Results disclosure agreements

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