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Trial record 36 of 170 for:    "Acute Lymphocytic Leukemia" | "Etoposide"

Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia (Rituximab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230788
Recruitment Status : Terminated (Lack of enrollment)
First Posted : October 29, 2010
Results First Posted : August 18, 2014
Last Update Posted : December 1, 2014
Sponsor:
Information provided by (Responsible Party):
Todd M. Cooper, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Acute Lymphoblastic Leukemia
ALL
Intervention Drug: rituximab
Enrollment 1
Recruitment Details One participant recruited between September 2010 and June 2011 at Children's Healthcare of Atlanta.
Pre-assignment Details  
Arm/Group Title Rituximab Arm
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Prescribed exclusion drug             1
Arm/Group Title Rituximab Arm
Hide Arm/Group Description 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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
no patients were analyzed due to early termination of study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title 4 Month Event Free Survival (EFS)
Hide Description To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.
Time Frame one year after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
Arm/Group Title Rituximab Arm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Toxicities of Rituximab
Hide Description To describe the toxicities of rituximab in addition to prednisone, etoposide, and ifosfamide.
Time Frame two months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
Arm/Group Title Rituximab Arm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Remission Induction Rate
Hide Description To estimate the remission induction rate of the addition of rituximab to cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
Arm/Group Title Rituximab Arm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Minimal Residual Disease
Hide Description To perform serial minimal residual disease (MRD) measurements to provide an objective determination of the effectiveness of this therapy.
Time Frame one month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
Arm/Group Title Rituximab Arm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Prednisone Effect
Hide Description To correlate the effect of prednisone on CD20 expression using serial measurements of CD20 expression in leukemic blasts.
Time Frame one month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Arm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study, therefore no serious and other [non-serious] adverse events were collected or assessed as part of the study.
 
Arm/Group Title Rituximab Arm
Hide Arm/Group Description 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.
All-Cause Mortality
Rituximab Arm
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Rituximab Arm
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab Arm
Affected / at Risk (%)
Total   0/0 
The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Todd Cooper
Organization: Emory University
Phone: 404-785-3000
EMail: tmcoope@emory.edu
Layout table for additonal information
Responsible Party: Todd M. Cooper, Emory University
ClinicalTrials.gov Identifier: NCT01230788    
Other Study ID Numbers: IRB00039682
Rituximab ( Other Identifier: Other )
First Submitted: October 23, 2010
First Posted: October 29, 2010
Results First Submitted: July 30, 2014
Results First Posted: August 18, 2014
Last Update Posted: December 1, 2014