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Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia (Interfant06)

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ClinicalTrials.gov Identifier: NCT00550992
Recruitment Status : Unknown
Verified February 2019 by Dutch Childhood Oncology Group.
Recruitment status was:  Recruiting
First Posted : October 30, 2007
Last Update Posted : July 30, 2019
BFM Germany
CORS Monza Italy
Associazione Italiana Ematologia Oncologia Pediatrica
Australian and New Zealand Children's Oncology Group
BFM Austria
CLCG France Belgium Portugal
COALL Germany
CPH, Czech republic
DFCI consortium USA
Hong Kong
MD Anderson USA
NOPHO Scandinavian countries
PINDA, Chile
Seattle USA
UKCCSG United Kingdom
Information provided by (Responsible Party):
Dutch Childhood Oncology Group

Brief Summary:

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia.

PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: anti-thymocyte globulin Drug: asparaginase Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: melphalan Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: pegaspargase Drug: prednisolone Drug: prednisone Drug: therapeutic hydrocortisone Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: umbilical cord blood transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia
Actual Study Start Date : January 2006
Estimated Primary Completion Date : December 2020

Primary Outcome Measures :
  1. Disease-free survival

Secondary Outcome Measures :
  1. Survival
  2. Event-free survival
  3. Event-free survival within each risk group (i.e., low-risk, medium-risk, or high-risk)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Inclusion criteria:

  • 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 criteria:

  • 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


  • See Disease Characteristics


  • More than 4 weeks since prior systemic corticosteroids

    • Corticosteroids by aerosol are allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550992

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United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lewis B. Silverman, MD    617-632-5285      
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Clinical Trials Office - St. Jude Children's Research Hospital    901-595-4644      
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U    713-792-3245      
United States, Washington
Children's Hospital and Regional Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Blythe Thomson, MD    206-987-2106      
St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Georg Mann, MD    43-1-4017-1250      
Hopital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Alice Ferster, MD    32-2-477-2678    aferster@ulb.ac.be   
University Hospital Motol Recruiting
Prague, Czechia, 150 06
Contact: Jan Stary, MD    420-2-2443-6401    jan.stary@lfmotol.cuni.cz   
CHR Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Francoise Mechinaud, MD    33-1-4249-9046      
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Gritta Janka-Schaub    49-404-2803-2580      
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, D-30625
Contact: Martin Schrappe, MD, PhD    49-511-532-6713      
Nuovo Ospedale San Gerardo at University of Milano-Bicocca Recruiting
Monza, Italy, 20052
Contact: Andrea Biondi, MD    39-039-233-3661    biondi@galactica.it   
Erasmus MC - Sophia Children's Hospital Recruiting
Rotterdam, Netherlands, 3015 GJ
Contact: Rob Pieters, MD, MSC, PhD    31-88-97 26003    rpieters@prinsesmaximacentrum.nl   
United Kingdom
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Phil Ancliff, MD    44-20-7829-8831      
Sponsors and Collaborators
Dutch Childhood Oncology Group
BFM Germany
CORS Monza Italy
Associazione Italiana Ematologia Oncologia Pediatrica
Australian and New Zealand Children's Oncology Group
BFM Austria
CLCG France Belgium Portugal
COALL Germany
CPH, Czech republic
DFCI consortium USA
Hong Kong
MD Anderson USA
NOPHO Scandinavian countries
PINDA, Chile
Seattle USA
UKCCSG United Kingdom
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Study Chair: Rob Pieters, MD, MSC, PhD Prinses Maxima Centrum voor kinderoncologie Utrecht
Study Chair: Martin Schrappe, MD, PhD University Hospital Schleswig-Holstein
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dutch Childhood Oncology Group
ClinicalTrials.gov Identifier: NCT00550992    
Other Study ID Numbers: CDR0000570260
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: February 2019
Keywords provided by Dutch Childhood Oncology Group:
untreated childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
acute undifferentiated leukemia
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs