OPHO-ALL-2008 Treatment Protocol for Children (1.0 - 17.9 years of age) with Acute Lymphoblastic Leukemia

Rigshospitalet0 sites1,000 target enrollmentDecember 17, 2008

Conditionsacute lymphoblastic leukemia MedDRA version: 17.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: acute lymphoblastic leukemia
Sponsor: Rigshospitalet
Enrollment: 1000
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 17, 2008

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Rigshospitalet

Eligibility Criteria

Inclusion Criteria

•1\. Non B\-ALL
•2\. Non Ph\+ ALL
•3\. Age 1\.0 \- 17\.9 years of age.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 160
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\. Bilineage ALL.
•2\. Pre\-treatment with glucocorticosteroids or other antileukemic agents. Patients, who have been treated with systemic glucocorticosteroids or other anticancer agents (e.g. methotrexate or thiopurines) for more than a week prior to the diagnosis of ALL and initiation of antileukemic therapy, can be treated by the NOPHO ALL\-2008 protocol and will be registered, but they cannot be included in the randomised trials.
•3\. Incomplete exploration for the risk group stratifying cytogenetic aberrations.
•4\. ALL predisposition syndromes. Patients with certain ALL\-predisposing disorders (e.g. Down syndrome, Ataxia Telangiectasia) can be entered into the protocol with the amendments outlined in section 16, but can not be included in the randomised trials.
•5\. Previous cancer. Patients who have previously been treated for a malignant neoplasm can be treated by the NOPHO ALL\-2008 protocol and will be registered, but they cannot be included in the randomised trials (see section 16\). They will be treated according to the control arms of the protocol.
•6\. Intolerance to one or more anticancer agent.
•7\. Administration of additional chemotherapy during induction therapy for non\-HR ALL. Patients with non\-HR ALL, who at day 15 have a M3 bone marrow should not be given additional chemotherapy. If given, the patients will not be eligible for the SR\-ALL treatment arm and the patient will not be eligible for randomisation.
•8\. Sexually active females not using contraception.
•9\. TPMT\-deficiency (6MP\-randomisation only).
•10\. DepoCyte during induction therapy (DepoCyte randomisation only)