Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00144963
First received: September 1, 2005
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: May 11, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Lymphoblastic Leukemia
Interventions: Drug: Vincristine Sulfate Liposomes Injection
Drug: Dexamethasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
VSLI Vincristine Sulfate Liposomes Injection (VSLI)

Participant Flow:   Overall Study
    VSLI  
STARTED     36  
COMPLETED     36  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
VSLI Vincristine Sulfate Liposomes Injection (VSLI)

Baseline Measures
    VSLI  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  36.3  ± 13.83  
Gender  
[units: participants]
 
Female     12  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures

1.  Primary:   MTD of VSLI   [ Time Frame: 6 weeks ]
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Measure Type Primary
Measure Title MTD of VSLI
Measure Description Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.
Time Frame 6 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.

Reporting Groups
  Description
VSLI Vincristine Sulfate Liposomes Injection (VSLI)

Measured Values
    VSLI  
Number of Participants Analyzed  
[units: participants]
  26  
MTD of VSLI  
[units: mg/m2]
  2.25  

No statistical analysis provided for MTD of VSLI




  Serious Adverse Events
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Time Frame start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
Additional Description No text entered.

Reporting Groups
  Description
VSLI Vincristine Sulfate Liposomes Injection (VSLI)

Serious Adverse Events
    VSLI  
Total, serious adverse events    
# participants affected / at risk     33/36 (91.67%)  
Blood and lymphatic system disorders    
febrile neutropenia * 1  
# participants affected / at risk     12/36 (33.33%)  
neutropenia * 1  
# participants affected / at risk     3/36 (8.33%)  
Cardiac disorders    
cardiac arrest * 1  
# participants affected / at risk     2/36 (5.56%)  
Gastrointestinal disorders    
abdominal pain * 1  
# participants affected / at risk     4/36 (11.11%)  
oesophagitis * 1  
# participants affected / at risk     2/36 (5.56%)  
General disorders    
pyrexia * 1  
# participants affected / at risk     10/36 (27.78%)  
Infections and infestations    
Bacteraemia * 1  
# participants affected / at risk     17/36 (47.22%)  
Pneumonia, fungal * 1  
# participants affected / at risk     3/36 (8.33%)  
pneumonia * 1  
# participants affected / at risk     2/36 (5.56%)  
Investigations    
alanine aminotransferase increased * 1  
# participants affected / at risk     2/36 (5.56%)  
aspartate aminotransferase increased * 1  
# participants affected / at risk     2/36 (5.56%)  
Metabolism and nutrition disorders    
dehydration * 1  
# participants affected / at risk     3/36 (8.33%)  
failure to thrive * 1  
# participants affected / at risk     2/36 (5.56%)  
hyperglycemia * 1  
# participants affected / at risk     2/36 (5.56%)  
Nervous system disorders    
peripheral neuropathy * 1  
# participants affected / at risk     2/36 (5.56%)  
Psychiatric disorders    
confusional state * 1  
# participants affected / at risk     2/36 (5.56%)  
mental status changes * 1  
# participants affected / at risk     2/36 (5.56%)  
Respiratory, thoracic and mediastinal disorders    
hypoxia * 1  
# participants affected / at risk     2/36 (5.56%)  
respiratory distress * 1  
# participants affected / at risk     2/36 (5.56%)  
respiratory failure * 1  
# participants affected / at risk     2/36 (5.56%)  
Vascular disorders    
hypotension * 1  
# participants affected / at risk     7/36 (19.44%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (12.1)




  Other Adverse Events
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Time Frame start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
VSLI Vincristine Sulfate Liposomes Injection (VSLI)

Other Adverse Events
    VSLI  
Total, other (not including serious) adverse events    
# participants affected / at risk     36/36  
Blood and lymphatic system disorders    
anaemia * 1  
# participants affected / at risk     17/36 (47.22%)  
febrile neutropenia * 1  
# participants affected / at risk     14/36 (38.89%)  
neutropenia * 1  
# participants affected / at risk     13/36 (36.11%)  
thrombocytopenia * 1  
# participants affected / at risk     13/36 (36.11%)  
leukopenia * 1  
# participants affected / at risk     2/36 (5.56%)  
Cardiac disorders    
tachycardia * 1  
# participants affected / at risk     9/36 (25.00%)  
cardiac arrest * 1  
# participants affected / at risk     2/36 (5.56%)  
sinus tachycardia * 1  
# participants affected / at risk     2/36 (5.56%)  
Eye disorders    
vision blurred * 1  
# participants affected / at risk     5/36 (13.89%)  
Gastrointestinal disorders    
constipation * 1  
# participants affected / at risk     24/36 (66.67%)  
nausea * 1  
# participants affected / at risk     17/36 (47.22%)  
abdominal pain * 1  
# participants affected / at risk     16/36 (44.44%)  
diarrhoea * 1  
# participants affected / at risk     15/36 (41.67%)  
abdominal distension * 1  
# participants affected / at risk     8/36 (22.22%)  
gatrooesophageal reflux disease * 1  
# participants affected / at risk     7/36 (19.44%)  
vomitting * 1  
# participants affected / at risk     6/36 (16.67%)  
abdominal discomfort * 1  
# participants affected / at risk     3/36 (8.33%)  
dyspepsia * 1  
# participants affected / at risk     3/36 (8.33%)  
dry mouth * 1  
# participants affected / at risk     2/36 (5.56%)  
gingival bleeding * 1  
# participants affected / at risk     2/36 (5.56%)  
oesophagitis * 1  
# participants affected / at risk     2/36 (5.56%)  
pancreatitis * 1  
# participants affected / at risk     2/36 (5.56%)  
rectal haemorrhage * 1  
# participants affected / at risk     2/36 (5.56%)  
General disorders    
fatigue * 1  
# participants affected / at risk     22/36 (61.11%)  
pyrexia * 1  
# participants affected / at risk     18/36 (50.00%)  
chills * 1  
# participants affected / at risk     12/36 (33.33%)  
oedema peripheral * 1  
# participants affected / at risk     7/36 (19.44%)  
oedema * 1  
# participants affected / at risk     5/36 (13.89%)  
asthenia * 1  
# participants affected / at risk     4/36 (11.11%)  
chest pain * 1  
# participants affected / at risk     4/36 (11.11%)  
pain * 1  
# participants affected / at risk     2/36 (5.56%)  
Hepatobiliary disorders    
hyperbilirubinaemia * 1  
# participants affected / at risk     3/36 (8.33%)  
Infections and infestations    
bacteraemia * 1  
# participants affected / at risk     9/36 (25.00%)  
staphylococcal bacteraemia * 1  
# participants affected / at risk     4/36 (11.11%)  
pneumonia * 1  
# participants affected / at risk     3/36 (8.33%)  
pneumonia fungal * 1  
# participants affected / at risk     3/36 (8.33%)  
bacterial infection * 1  
# participants affected / at risk     2/36 (5.56%)  
enterococcal bacteraemia * 1  
# participants affected / at risk     2/36 (5.56%)  
sepsis * 1  
# participants affected / at risk     2/36 (5.56%)  
urinary tract infection * 1  
# participants affected / at risk     2/36 (5.56%)  
Injury, poisoning and procedural complications    
contusion * 1  
# participants affected / at risk     3/36 (8.33%)  
Investigations    
alanine aminotransferase increased * 1  
# participants affected / at risk     9/36 (25.00%)  
aspartate aminotransferase increased * 1  
# participants affected / at risk     8/36 (22.22%)  
blood lactate dehydrogenase increased * 1  
# participants affected / at risk     6/36 (16.67%)  
blood alkaline phosphatase increased * 1  
# participants affected / at risk     4/36 (11.11%)  
blood urea increased * 1  
# participants affected / at risk     4/36 (11.11%)  
Metabolism and nutrition disorders    
hyperglycaemia * 1  
# participants affected / at risk     15/36 (41.67%)  
hypokalaemia * 1  
# participants affected / at risk     10/36 (27.78%)  
decreased appetite * 1  
# participants affected / at risk     9/36 (25.00%)  
hypomagnesaemia * 1  
# participants affected / at risk     9/36 (25.00%)  
dehydration * 1  
# participants affected / at risk     8/36 (22.22%)  
hypocalcaemia * 1  
# participants affected / at risk     6/36 (16.67%)  
hyperphosphataemia * 1  
# participants affected / at risk     3/36 (8.33%)  
hyponatraemia * 1  
# participants affected / at risk     3/36 (8.33%)  
hypophosphataemia * 1  
# participants affected / at risk     3/36 (8.33%)  
failure to thrive * 1  
# participants affected / at risk     2/36 (5.56%)  
hyperkalaemia * 1  
# participants affected / at risk     2/36 (5.56%)  
hyperuricaemia * 1  
# participants affected / at risk     2/36 (5.56%)  
metabolic acidosis * 1  
# participants affected / at risk     2/36 (5.56%)  
Musculoskeletal and connective tissue disorders    
myalgia * 1  
# participants affected / at risk     13/36 (36.11%)  
bone pain * 1  
# participants affected / at risk     12/36 (33.33%)  
arthralgia * 1  
# participants affected / at risk     6/36 (16.67%)  
muscular weakness * 1  
# participants affected / at risk     6/36 (16.67%)  
back pain * 1  
# participants affected / at risk     4/36 (11.11%)  
pain in extremity * 1  
# participants affected / at risk     4/36 (11.11%)  
muscle spasms * 1  
# participants affected / at risk     3/36 (8.33%)  
flank pain * 1  
# participants affected / at risk     2/36 (5.56%)  
myopathy * 1  
# participants affected / at risk     2/36 (5.56%)  
Nervous system disorders    
neuropathy peripheral * 1  
# participants affected / at risk     19/36 (52.78%)  
dizziness * 1  
# participants affected / at risk     10/36 (27.78%)  
headache * 1  
# participants affected / at risk     9/36 (25.00%)  
paraesthesia * 1  
# participants affected / at risk     8/36 (22.22%)  
hypoaesthesia * 1  
# participants affected / at risk     4/36 (11.11%)  
peripheral sensory neuropathy * 1  
# participants affected / at risk     4/36 (11.11%)  
encephalopathy * 1  
# participants affected / at risk     3/36 (8.33%)  
peripheral motor neuropathy * 1  
# participants affected / at risk     3/36 (8.33%)  
dysgeusia * 1  
# participants affected / at risk     2/36 (5.56%)  
neuralgia * 1  
# participants affected / at risk     2/36 (5.56%)  
tremor * 1  
# participants affected / at risk     2/36 (5.56%)  
Psychiatric disorders    
insomnia * 1  
# participants affected / at risk     16/36 (44.44%)  
anxiety * 1  
# participants affected / at risk     7/36 (19.44%)  
confusional state * 1  
# participants affected / at risk     7/36 (19.44%)  
mental status change * 1  
# participants affected / at risk     4/36 (11.11%)  
depression * 1  
# participants affected / at risk     2/36 (5.56%)  
sleep disorder * 1  
# participants affected / at risk     2/36 (5.56%)  
Reproductive system and breast disorders    
vaginal haemorrhage * 1  
# participants affected / at risk     2/36 (5.56%)  
Respiratory, thoracic and mediastinal disorders    
cough * 1  
# participants affected / at risk     11/36 (30.56%)  
dyspnoea * 1  
# participants affected / at risk     8/36 (22.22%)  
hiccups * 1  
# participants affected / at risk     5/36 (13.89%)  
oropharyngeal pain * 1  
# participants affected / at risk     4/36 (11.11%)  
pleural effusion * 1  
# participants affected / at risk     4/36 (11.11%)  
hypoxia * 1  
# participants affected / at risk     3/36 (8.33%)  
pleuritic pain * 1  
# participants affected / at risk     3/36 (8.33%)  
rhinitis alergic * 1  
# participants affected / at risk     3/36 (8.33%)  
atelectasis * 1  
# participants affected / at risk     2/36 (5.56%)  
dysphonia * 1  
# participants affected / at risk     2/36 (5.56%)  
epistasis * 1  
# participants affected / at risk     2/36 (5.56%)  
respiratory distress * 1  
# participants affected / at risk     2/36 (5.56%)  
respiratory failure * 1  
# participants affected / at risk     2/36 (5.56%)  
rhinorrhoea * 1  
# participants affected / at risk     2/36 (5.56%)  
sinus congestion * 1  
# participants affected / at risk     2/36 (5.56%)  
Skin and subcutaneous tissue disorders    
rash * 1  
# participants affected / at risk     5/36 (13.89%)  
petechiae * 1  
# participants affected / at risk     4/36 (11.11%)  
dry skin * 1  
# participants affected / at risk     3/36 (8.33%)  
ecchymosis * 1  
# participants affected / at risk     2/36 (5.56%)  
erythema * 1  
# participants affected / at risk     2/36 (5.56%)  
hyperhidrosis * 1  
# participants affected / at risk     2/36 (5.56%)  
night sweats * 1  
# participants affected / at risk     2/36 (5.56%)  
Vascular disorders    
hypotension * 1  
# participants affected / at risk     12/36 (33.33%)  
hypertension * 1  
# participants affected / at risk     5/36 (13.89%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (12.1)



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: VP, Regulatory Affairs
Organization: Talon Therapeutics
phone: 650-228-5066
e-mail: ttarlow@talontx.com


No publications provided


Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00144963     History of Changes
Other Study ID Numbers: VSLI-06-ALL
Study First Received: September 1, 2005
Results First Received: May 11, 2012
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration