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Trial record 48 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT

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ClinicalTrials.gov Identifier: NCT02349178
Recruitment Status : Terminated (Low accrual)
First Posted : January 28, 2015
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
American Family Children’s Hospital
Nationwide Children's Hospital
Information provided by (Responsible Party):
Michael Burke, Medical College of Wisconsin

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia, Acute Lymphoblastic
Acute Myeloid Leukemia
Interventions Drug: Clofarabine
Drug: Cyclophosphamide
Drug: Etoposide
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bridging Arm
Hide Arm/Group Description

Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion

Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours

Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion

Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Bridging Arm
Hide Arm/Group Description

Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion

Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours

Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion

Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
5
  83.3%
Between 18 and 65 years
1
  16.7%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
 100.0%
1.Primary Outcome
Title Minimal Residual Disease
Hide Description A bone marrow evaluation to determine study response and remission status will be performed on study Day 30 or upon adequate blood count recovery (ANC > 0.50 and platelet > 50,000), whichever occurs first. If the marrow is hypocellular and without evidence of normal tri-lineage hematopoiesis the marrow should be repeated at Day 42.
Time Frame Day 30 or adequate blood recovery
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bridging Arm
Hide Arm/Group Description:

Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion

Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours

Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion

Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
MRD Positive
3
  50.0%
MRD Negative
3
  50.0%
Time Frame Up to Day 60 from start of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bridging Arm
Hide Arm/Group Description

Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion

Clofarabine: Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours

Cyclophosphamide: Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion

Etoposide: Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours

All-Cause Mortality
Bridging Arm
Affected / at Risk (%)
Total   0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bridging Arm
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Infections and infestations   
Sepsis  [1]  1/6 (16.67%)  1
Renal and urinary disorders   
acute kidney injury  [2]  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
[1]
Patient presented with a heart rate in the 150s and feeling very weak and with a sore throat. She met the criteria for severe sepsis and was admitted to their intensive care unit.
[2]
Creatinine increased - Patient presented to clinic with elevated creatinine x3 from baseline. Patient admitted for IV fluids and monitoring on 5/18/15. Progressed to acute kidney injury
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bridging Arm
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
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: Michael J Burke, MD
Organization: Medical College of Wisconsin
Phone: 414-955-4170
EMail: mmburke@mcw.edu
Layout table for additonal information
Responsible Party: Michael Burke, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02349178     History of Changes
Other Study ID Numbers: Bridging
First Submitted: January 23, 2015
First Posted: January 28, 2015
Results First Submitted: December 12, 2018
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019