NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia

This study has been completed.

Sponsor:

Information provided by:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT00548431

First received: October 23, 2007

Last updated: November 9, 2010

Last verified: November 2010

History of Changes

Results First Received: June 24, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Leukemia, Lymphocytic, Acute
Intervention:	Drug: 6-mercaptopurine

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
38 patients were recruited in 3 different countries. Recruitment period 12/01/2007 - 12/21/2008. All recruitments were done in departments of Pediatric Hematology/oncology

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
6-mercaptopurine	All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable

Participant Flow: Overall Study

	6-mercaptopurine
STARTED	38
COMPLETED	38
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
6-mercaptopurine	All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable

Baseline Measures

	6-mercaptopurine
Number of Participants [units: participants]	38
Age [units: participants]
<=18 years	38
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	7 ± 3
Gender [units: participants]
Female	21
Male	17
Region of Enrollment [units: participants]
Denmark	12
Sweden	21
Finland	5

Outcome Measures

1. Primary:

Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported [ Time Frame: 3 months ( 79 days ) ]

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Measure Type	Primary
Measure Title	Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported
Measure Description	Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.
Time Frame	3 months ( 79 days )
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.
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Reporting Groups

	Description
6-mercaptopurine	All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable

Measured Values

	6-mercaptopurine
Number of Participants Analyzed [units: participants]	38
Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported [units: Participants]	26

No statistical analysis provided for Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported

2. Secondary:

Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production [ Time Frame: During the 3 months consolidation therapy ]

Results not yet posted. Anticipated Posting Date: 12/2010 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

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
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Results Point of Contact:

Name/Title: Thomas Frandsen
Organization: Rigshospitalet, Juliane Marie Centret
phone: +45 35458364
e-mail: thomas.leth.frandsen@rh.regionh.dk

No publications provided

Responsible Party:	Kjeld Schmiegelow, professor, Pediatric Clinic; Rigshopsitalet, Copenhagen DK-2100
ClinicalTrials.gov Identifier:	NCT00548431 History of Changes
Other Study ID Numbers:	NOPHO HDM-6MP pilot study
Study First Received:	October 23, 2007
Results First Received:	June 24, 2009
Last Updated:	November 9, 2010
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: Ethics Committee Denmark: The Regional Committee on Biomedical Research Ethics

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