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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Talon Therapeutics, Inc

ClinicalTrials.gov Identifier:

NCT00144963

First received: September 1, 2005

Last updated: May 11, 2012

Last verified: December 2011

History of Changes

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
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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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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	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:	Talon Therapeutics, 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:	May 11, 2012
Health Authority:	United States: Food and Drug Administration

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