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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Dutch Childhood Oncology Group.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
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
FRALLE France
Hong Kong
MD Anderson USA
NOPHO Scandinavian countries
PINDA, Chile
PPLLSG Poland
Seattle USA
SJCRH USA
UKCCSG United Kingdom
Information provided by (Responsible Party):
Dutch Childhood Oncology Group
ClinicalTrials.gov Identifier:
NCT00550992
First received: October 22, 2007
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia

Resource links provided by NLM:


Further study details as provided by Dutch Childhood Oncology Group:

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Event-free survival within each risk group (i.e., low-risk, medium-risk, or high-risk) [ Designated as safety issue: No ]

Estimated Enrollment: 445
Study Start Date: June 2007
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Year   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior systemic corticosteroids

    • Corticosteroids by aerosol are allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550992

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02215
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Austria
St. Anna Children's Hospital
Vienna, Austria, A-1090
Belgium
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium, 1020
Czech Republic
University Hospital Motol
Prague, Czech Republic, 150 06
France
CHR Hotel Dieu
Nantes, France, 44093
Germany
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Italy
Nuovo Ospedale San Gerardo at University of Milano-Bicocca
Monza, Italy, 20052
Netherlands
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands, 3015 GJ
United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
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
FRALLE France
Hong Kong
MD Anderson USA
NOPHO Scandinavian countries
PINDA, Chile
PPLLSG Poland
Seattle USA
SJCRH USA
UKCCSG United Kingdom
Investigators
Study Chair: Rob Pieters, MD, MSC, PhD Erasmus MC - Sophia Children's Hospital
Study Chair: Martin Schrappe, MD, PhD University of Schleswig-Holstein
  More Information

Additional Information:
Responsible Party: Dutch Childhood Oncology Group
ClinicalTrials.gov Identifier: NCT00550992     History of Changes
Other Study ID Numbers: CDR0000570260  DCOG-INTERFANT-06  EUDRACT-2005-004599-19  CCLG-LK-2006-10 
Study First Received: October 22, 2007
Last Updated: February 14, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Prednisone
Prednisolone
Hydrocortisone
Pegaspargase
Cyclophosphamide
Etoposide
Cytarabine
Vincristine
Methotrexate
Melphalan
Busulfan
Daunorubicin
Asparaginase
Mitoxantrone
6-Mercaptopurine
Thioguanine
Cyclosporins
Cyclosporine
Antilymphocyte Serum
Levoleucovorin
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on December 02, 2016