Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia

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

Interventions

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

Sponsors & Collaborators

• BFM Germany

  collaborator UNKNOWN

• CORS Monza Italy

  collaborator UNKNOWN

• Associazione Italiana Ematologia Oncologia Pediatrica

  collaborator OTHER

• Australian and New Zealand Children's Oncology Group

  collaborator OTHER

• BFM Austria

  collaborator UNKNOWN

• CLCG France Belgium Portugal

  collaborator UNKNOWN

• COALL Germany

  collaborator UNKNOWN

• CPH, Czech republic

  collaborator UNKNOWN

• DFCI consortium USA

  collaborator UNKNOWN

• FRALLE France

  collaborator UNKNOWN

• Hong Kong Government

  collaborator OTHER_GOV

• MD Anderson USA

  collaborator UNKNOWN

• NOPHO Scandinavian countries

  collaborator UNKNOWN

• PINDA, Chile

  collaborator UNKNOWN

• PPLLSG Poland

  collaborator UNKNOWN

• Seattle USA

  collaborator UNKNOWN

• SJCRH USA

  collaborator UNKNOWN

• UKCCSG United Kingdom

  collaborator UNKNOWN

• Dutch Childhood Oncology Group

  lead OTHER

Principal Investigators

• Rob Pieters, MD, MSC, PhD · Prinses Maxima Centrum voor kinderoncologie Utrecht

• Martin Schrappe, MD, PhD · University Hospital Schleswig-Holstein

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2020-12-31

Countries

• United States
• Austria
• Belgium
• Czechia
• France
• Germany
• Italy
• Netherlands
• United Kingdom

Study Locations