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Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00983528
Recruitment Status : Terminated (Support withdrawn due to slow accrual)
First Posted : September 24, 2009
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of California, San Diego

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lymphoblastic Leukemia
Interventions Biological: Alemtuzumab
Drug: Clofarabine
Enrollment 6
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Alemtuzumab and Clofarabine
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 6
Completed 0
Not Completed 6
Reason Not Completed
Death             4
Lost to Follow-up             1
Study Terminated             1
Arm/Group Title Alemtuzumab and Clofarabine
Hide Arm/Group Description 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 Number of Baseline Participants 6
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
41.85
(23 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
3
  50.0%
Not Hispanic or Latino
3
  50.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title To Determine the Maximum Tolerated Dose of Clofarabine When Administered in Combination With Alemtuzumab as Measured by CTC Version 3.0. (Phase 1)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alemtuzumab and Clofarabine
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Adverse Events
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab and Clofarabine
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: adverse events
Nose Bleed 1
Diarrhea 5
Nausea 6
Vomiting 6
Dyspesia 1
Fever 4
Constipation 5
Pain 6
Insomnia 6
Itching 4
Anxiety 6
Rash 1
Hives 1
Dry Eyes 1
Deaths 4
Time Frame [Not Specified]
Adverse Event Reporting Description There is no longer access to participant level data for any Adverse Events collected in this study, therefore we report 0 participants at risk in this module. Please refer to Outcome Measure 2 where the available Adverse Event information for this study is reported
 
Arm/Group Title Alemtuzumab and Clofarabine
Hide Arm/Group Description 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)
All-Cause Mortality
Alemtuzumab and Clofarabine
Affected / at Risk (%)
Total   4/6 (66.67%) 
Hide Serious Adverse Events
Alemtuzumab and Clofarabine
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alemtuzumab and Clofarabine
Affected / at Risk (%)
Total   0/0 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: MCC Clinical Trials Office
Organization: UC San Diego
Phone: (858) 534-5417
EMail: tkipps@ucsd.edu
Layout table for additonal information
Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT00983528    
Other Study ID Numbers: 090331
First Submitted: September 23, 2009
First Posted: September 24, 2009
Results First Submitted: January 23, 2020
Results First Posted: August 12, 2020
Last Update Posted: August 12, 2020