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Trial Outcomes & Findings for Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT (NCT NCT02349178)

NCT ID: NCT02349178

Last Updated: 2020-03-09

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Day 30 or adequate blood recovery

Results posted on

2020-03-09

Participant Flow

Participant milestones

Participant milestones
Measure
Bridging Arm
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 Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Bridging Arm
n=6 Participants
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
Age, Categorical
<=18 years
5 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Sex: Female, Male
Female
3 Participants
n=93 Participants
Sex: Female, Male
Male
3 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
1 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
Race (NIH/OMB)
White
5 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
6 Participants
n=93 Participants

PRIMARY outcome

Timeframe: Day 30 or adequate blood recovery

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.

Outcome measures

Outcome measures
Measure
Bridging Arm
n=6 Participants
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
Minimal Residual Disease
MRD Positive
3 Participants
Minimal Residual Disease
MRD Negative
3 Participants

Adverse Events

Bridging Arm

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Bridging Arm
n=6 participants at risk
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
Renal and urinary disorders
acute kidney injury
16.7%
1/6 • Number of events 1 • Up to Day 60 from start of study drug
Infections and infestations
Sepsis
16.7%
1/6 • Number of events 1 • Up to Day 60 from start of study drug

Other adverse events

Adverse event data not reported

Additional Information

Michael J Burke, MD

Medical College of Wisconsin

Phone: 414-955-4170

Results disclosure agreements

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