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Closed (no longer recruiting)Last updated: 24 January 2024

Interfant 06: This trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemiaInternational collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukaemia (Other IDs: CDR0000570260, DCOG-INTERFANT-06, EudraCT 2005-004599-19, CCLG-LK-2006-10).

Clinical summary

Summary

Infant acute lymphoblastic leukaemia (ALL) is a rare disease and comprises about 4% of childhood ALL. Whereas the outcome of older children with ALL has improved to 80-85% event-free survival (EFS) infants with ALL have a worse prognosis.In 1999, a large international collaborative study group was started to develop common treatment protocols for infant ALL to try to improve the outcome for these very young children.The primary aim of the study is to assess the role of early intensification of two acute myeloid leukemia induction blocks versus standard IB protocol directly after induction, in a randomised way in MR and HR patients.The secondary aims of the study are:to assess the overall outcome of the Interfant-06 protocol compared to the historical control series, especially the Interfant-99, to assess the outcome of LR, MR and HR patients as compared to the historical control series in Interfant99, to study which factors have independent prognostic value and to assess the role of stem cell transplant (SCT) in HR patients.

Conditions

This trial is treating patients with Acute Lymphoblastic Leukaemia

Cancer

Blood Cancers Haematological

Age

People0 - 1

Phase

Unknown

Trial Acronym

Interfant 06

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Dutch Childhood Oncology Group

Scientific Title

International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukaemia (Other IDs: CDR0000570260, DCOG-INTERFANT-06, EudraCT 2005-004599-19, CCLG-LK-2006-10).

Eligibility

Inclusion

  • Diagnosis of acute lymphoblastic leukemia (ALL) or biphenotypic leukemia meeting the following criteria:

    • Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria
    • Newly diagnosed disease
    • Verified by morphology and confirmed by cytochemistry and immunophenotyping

      • Trephine biopsy is recommended (unless diagnosis can be confirmed by peripheral blood examination) in the event that bone marrow aspiration results in a "dry tap"
  • Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets 1 of the following risk criteria:

    • Low-risk disease, defined as all MLL germline cases
    • Medium-risk disease, defined by 1 of the following criteria:

      • MLL status unknown
      • MLL rearranged AND age > 6 months
      • MLL rearranged AND age < 6 months AND WBC < 300 x 10^9/L AND prednisone good response
    • High-risk disease, defined by MLL rearrangement AND meets the following criteria:

      • Age at diagnosis < 6 months (i.e., < 183 days)
      • WBC ≥ 300 x 10^9/L AND/OR prednisone poor response
  • Minimum donor and stem cell requirements for high-risk patients undergoing stem cell transplantation:

    • Donor meeting 1 of the following criteria:

      • HLA-identical sibling
      • Very well-matched related or unrelated donor
      • Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping
    • Stem cell source

      • Bone marrow (preferred source) OR peripheral blood stem cells of filgrastim [G-CSF]-stimulated donors OR cord blood

        • Highly-matched unrelated umbilical cord blood (UCB) (> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., > 1.5 x 10^7/kg recipient body weight [BW]) is cryopreserved
    • Must have ≥ 3 x 10^8 NCs/kg BW OR 3 x 10^6/kg BW CD34-positive cells available for transplantation
  • CNS or testicular leukemia at diagnosis allowed

Exclusion

  • Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL
  • Presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible)
  • Relapsed ALL
  • More than 4 weeks since prior systemic corticosteroids

    • Corticosteroids by aerosol are allowed

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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