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

NCT00548431 | Completed Phase 2 Results DMC

• 1 other identifier: NOPHO HDM-6MP pilot study
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 3

Brief Summary

The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.

Conditions

Leukemia, Lymphocytic, Acute

Keywords

Leukemia, Lymphocytic, Acute [C04.557.337.428.511]; 6-mercaptopurine; methotrexate; asparaginase

Outcome Measures

Primary Outcomes (1)

• Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported

  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.

  3 months ( 79 days )

Secondary Outcomes (1)

• Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production

  During the 3 months consolidation therapy

Study Arms (1)

6 mercaptopurine arm

EXPERIMENTAL

All patients received basic daily 6MP (6-mercaptopurine) (25 mg/m\^2) and in addition high-dose methotrexate(HDM) every 3rd week (3 times HDM in total) and PEG-asparaginase every 14th day. Patients increased the dose of 6MP 2 weeks after each HDM if if the myelotoxicity had been acceptable. This means 2 increments since the study stopped 2 weeks after the last HDM

Drug: 6-mercaptopurine

Interventions

6-mercaptopurine DRUG

Standard dose 25 mg/m\^2/day. Can be increased up to 75 mg/m\^2/day if the myelosuppression is acceptable (ANC\>0.5 T-count \>50)

Also known as: PURINETHOL

6 mercaptopurine arm

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• B-lineage ALL
• years
• WBC \<100, clinical remission obtained day 2
• Written consent to participation.

You may not qualify if:

• t(9;22)
• Hypodiploidy
• q23-aberrations
• TPMT-deficiency
• Intolerance to MTX or 6MP

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (3)

Department of Pediatrics, Rigshospitalet

Copenhagen, Denmark

Location

Department of Pediatrics, University Hospital

Odense, Denmark

Location

Department of Pediatrics, Drottning Sylvias Pediatric Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Interventions

Mercaptopurine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Thomas Frandsen
• Organization: Rigshospitalet, Juliane Marie Centret

thomas.leth.frandsen@rh.regionh.dk

+45 35458364

Study Officials

• Kjeld Schmiegelow, M.D.

  Pediatric Clinic II, RIgshospitalet, Copenhagen, DK-2100

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Study Start: December 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 9, 2017
• Results First Posted: November 3, 2010

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

SE (1); DK (2)