Trial Outcomes & Findings for Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients (NCT NCT00412243)

Last Updated: 2013-03-12

Results Overview

MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/\> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

51 participants

Primary outcome timeframe

First 14 days of each cycle

Results posted on

2013-03-12

Participant Flow

Recruitment Period 3/21/2006 - 3/3/2011; all patients were registered at The University of Texas M.D. Anderson Cancer Center.

One enrolled participant was excluded.

Participant milestones

Participant milestones
Measure	Clofarabine + Cyclophosphamide Clofarabine 40 mg/m\^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m\^2 every 12 hours for 3 days Clofarabine : 40 mg/m\^2 Daily for 3 Days Cyclophosphamide : Beginning dose 200 mg/m\^2 every 12 hours for 3 days
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clofarabine + Cyclophosphamide n=50 Participants Clofarabine 40 mg/m\^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m\^2 every 12 hours for 3 days Clofarabine : 40 mg/m\^2 Daily for 3 Days Cyclophosphamide : Beginning dose 200 mg/m\^2 every 12 hours for 3 days
Age Continuous	30 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: First 14 days of each cycle

Population: MTD calculated with first 8 study participants.

Outcome measures

Outcome measures
Measure	Clofarabine + Cyclophosphamide n=8 Participants Clofarabine 40 mg/m\^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m\^2 every 12 hours for 3 days Clofarabine : 40 mg/m\^2 Daily for 3 Days Cyclophosphamide : Beginning dose 200 mg/m\^2 every 12 hours for 3 days
Maximum Tolerated Dose for Cyclophosphamide (MTD)	200 mg/m^2

Adverse Events

Clofarabine + Cyclophosphamide

Serious events: 13 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clofarabine + Cyclophosphamide n=50 participants at risk Clofarabine 40 mg/m\^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m\^2 every 12 hours for 3 days Clofarabine : 40 mg/m\^2 Daily for 3 Days Cyclophosphamide : Beginning dose 200 mg/m\^2 every 12 hours for 3 days
Gastrointestinal disorders Diarrhea	2.0% 1/50 • Number of events 1 • Six years
General disorders Death	16.0% 8/50 • Number of events 8 • Six years
Blood and lymphatic system disorders Elevated Amylase	2.0% 1/50 • Number of events 1 • Six years
Nervous system disorders Syncope	2.0% 1/50 • Number of events 1 • Six years
Renal and urinary disorders Renal Failure	4.0% 2/50 • Number of events 2 • Six years
Infections and infestations Infection	8.0% 4/50 • Number of events 4 • Six years
Blood and lymphatic system disorders Elevated Lipase	2.0% 1/50 • Number of events 1 • Six years
Hepatobiliary disorders Hyperbiliruninemia	2.0% 1/50 • Number of events 1 • Six years
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.0% 1/50 • Number of events 1 • Six years

Other adverse events

Other adverse events
Measure	Clofarabine + Cyclophosphamide n=50 participants at risk Clofarabine 40 mg/m\^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m\^2 every 12 hours for 3 days Clofarabine : 40 mg/m\^2 Daily for 3 Days Cyclophosphamide : Beginning dose 200 mg/m\^2 every 12 hours for 3 days
Gastrointestinal disorders Nausea/Vomiting	78.0% 39/50 • Number of events 44 • Six years
Gastrointestinal disorders Dairrhea	32.0% 16/50 • Number of events 18 • Six years
Gastrointestinal disorders Stomatitis/Mucositis	12.0% 6/50 • Number of events 6 • Six years
Skin and subcutaneous tissue disorders Rash	14.0% 7/50 • Number of events 7 • Six years
Nervous system disorders Headache	34.0% 17/50 • Number of events 17 • Six years
Hepatobiliary disorders Elevated Liver Function Tests	50.0% 25/50 • Number of events 25 • Six years
Skin and subcutaneous tissue disorders Hand Foot Syndrome	6.0% 3/50 • Number of events 3 • Six years

Additional Information

Stefan Fader, M.D./Associate Professor

The University of Texas M. D. Anderson Cancer Center

Phone: 713/745-4613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place