Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Summary

Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome

Conditions

• Childhood Acute Erythroleukemia (M6)
• Childhood Acute Megakaryocytic Leukemia (M7)
• Childhood Acute Monoblastic Leukemia (M5a)
• Childhood Acute Monocytic Leukemia (M5b)
• Childhood Acute Myeloblastic Leukemia With Maturation (M2)
• Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
• Childhood Acute Myelomonocytic Leukemia (M4)
• Childhood Myelodysplastic Syndromes
• Chronic Myelomonocytic Leukemia
• de Novo Myelodysplastic Syndromes
• Refractory Anemia
• Refractory Anemia With Excess Blasts
• Refractory Anemia With Excess Blasts in Transformation
• Refractory Anemia With Ringed Sideroblasts
• Secondary Myelodysplastic Syndromes
• Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

Interventions

DRUG

asparaginase

DRUG

daunorubicin hydrochloride

DRUG

fludarabine phosphate

DRUG

therapeutic hydrocortisone

PROCEDURE

allogeneic bone marrow transplantation

RADIATION

3-dimensional conformal radiation therapy

BIOLOGICAL

filgrastim

Given SC

DRUG

cytarabine

Given IV or IT

DRUG

idarubicin

Given IV

DRUG

dexamethasone

Given PO

DRUG

thioguanine

Given PO

DRUG

etoposide

Given IV

DRUG

methotrexate

Given IT

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

aldesleukin

DRUG

busulfan

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Beverly Lange · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1996-08-31

Primary Completion

2006-09-30

Countries

• United States

Study Locations