Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia

NCT00550992 | Unknown DMC

• 4 other identifiers: CDR0000570260DCOG-INTERFANT-06EUDRACT-2005-004599-19CCLG-LK-2006-10
• Study Type: interventional
• Target: 445
• Locations: 9 countries
• Sites: 13

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.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia; acute undifferentiated leukemia

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (3)

• Survival

• Event-free survival

• Event-free survival within each risk group (i.e., low-risk, medium-risk, or high-risk)

Interventions

anti-thymocyte globulin BIOLOGICAL

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 DRUG

allogeneic bone marrow transplantation PROCEDURE

allogeneic hematopoietic stem cell transplantation PROCEDURE

umbilical cord blood transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Dutch Childhood Oncology Group: lead
• BFM Germany: collaborator
• CORS Monza Italy: collaborator
• Associazione Italiana Ematologia Oncologia Pediatrica: collaborator
• Australian and New Zealand Children's Oncology Group: collaborator
• BFM Austria: collaborator
• CLCG France Belgium Portugal: collaborator
• COALL Germany: collaborator
• CPH, Czech republic: collaborator
• DFCI consortium USA: collaborator
• FRALLE France: collaborator
• Hong Kong Government: collaborator
• MD Anderson USA: collaborator
• NOPHO Scandinavian countries: collaborator
• PINDA, Chile: collaborator
• PPLLSG Poland: collaborator
• Seattle USA: collaborator
• SJCRH USA: collaborator
• UKCCSG United Kingdom: collaborator

Study Sites (13)

Children's Hospital Boston

Boston, Massachusetts, 02215, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

RECRUITING

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

RECRUITING

St. Anna Children's Hospital

Vienna, A-1090, Austria

RECRUITING

Hopital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

University Hospital Motol

Prague, 150 06, Czechia

RECRUITING

CHR Hotel Dieu

Nantes, 44093, France

RECRUITING

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

RECRUITING

Nuovo Ospedale San Gerardo at University of Milano-Bicocca

Monza, 20052, Italy

RECRUITING

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

RECRUITING

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

Related Publications (2)

• Stutterheim J, van der Sluis IM, de Lorenzo P, Alten J, Ancliffe P, Attarbaschi A, Brethon B, Biondi A, Campbell M, Cazzaniga G, Escherich G, Ferster A, Kotecha RS, Lausen B, Li CK, Lo Nigro L, Locatelli F, Marschalek R, Meyer C, Schrappe M, Stary J, Vora A, Zuna J, van der Velden VHJ, Szczepanski T, Valsecchi MG, Pieters R. Clinical Implications of Minimal Residual Disease Detection in Infants With KMT2A-Rearranged Acute Lymphoblastic Leukemia Treated on the Interfant-06 Protocol. J Clin Oncol. 2021 Feb 20;39(6):652-662. doi: 10.1200/JCO.20.02333. Epub 2021 Jan 6.

  PMID: 33405950 DERIVED

• Pieters R, De Lorenzo P, Ancliffe P, Aversa LA, Brethon B, Biondi A, Campbell M, Escherich G, Ferster A, Gardner RA, Kotecha RS, Lausen B, Li CK, Locatelli F, Attarbaschi A, Peters C, Rubnitz JE, Silverman LB, Stary J, Szczepanski T, Vora A, Schrappe M, Valsecchi MG. Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol: Results From an International Phase III Randomized Study. J Clin Oncol. 2019 Sep 1;37(25):2246-2256. doi: 10.1200/JCO.19.00261. Epub 2019 Jul 8.

  PMID: 31283407 DERIVED

MeSH Terms

Conditions

Leukemia; Leukemia, Biphenotypic, Acute

Interventions

Antilymphocyte Serum; Asparaginase; Busulfan; Cyclophosphamide; Cyclosporine; Cytarabine; Daunorubicin; Etoposide; Leucovorin; Melphalan; Mercaptopurine; Methotrexate; Mitoxantrone; pegaspargase; Prednisolone; Prednisone; Hydrocortisone; Thioguanine; Vincristine; Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Sulfhydryl Compounds; Purines; Aminopterin; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Rob Pieters, MD, MSC, PhD

  Prinses Maxima Centrum voor kinderoncologie Utrecht

  STUDY CHAIR

• Martin Schrappe, MD, PhD

  University Hospital Schleswig-Holstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 30, 2007
• Study Start: January 1, 2006
• Primary Completion: December 1, 2020
• Last Updated: July 30, 2019

Record last verified: 2019-02

Locations

BE (1); CZ (1); FR (1); NL (1); DE (2); AU (1); US (4); GB (1); IT (1)