Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
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ClinicalTrials.gov Identifier: NCT00002798 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : January 16, 2013
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: asparaginase Drug: daunorubicin hydrochloride Drug: fludarabine phosphate Drug: therapeutic hydrocortisone Procedure: allogeneic bone marrow transplantation Radiation: 3-dimensional conformal radiation therapy Biological: filgrastim Drug: cytarabine Drug: idarubicin Drug: dexamethasone Drug: thioguanine Drug: etoposide Drug: methotrexate Drug: cyclophosphamide Biological: aldesleukin Drug: busulfan | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 880 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS) |
Study Start Date : | August 1996 |
Actual Primary Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I (combination chemotherapy)
Patients receive treatment as in induction therapy, plus G-CSF SC beginning on day 16 and continuing until blood counts recover. If CSF is clear by day 10 of induction, patients receive cytarabine IT on days 0, 10, and 35. If CSF is not clear, patients receive triple intrathecal therapy (TIT; cytarabine, hydrocortisone, methotrexate) on days 0 and 10. See Detailed Description |
Drug: daunorubicin hydrochloride
Other Names:
Drug: therapeutic hydrocortisone Other Names:
Procedure: allogeneic bone marrow transplantation Other Names:
Biological: filgrastim Given SC
Other Names:
Drug: cytarabine Given IV or IT
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: thioguanine Given PO
Other Name: 6-TG Drug: etoposide Given IV
Other Names:
Drug: methotrexate Given IT
Other Names:
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Experimental: Arm II (combination chemotherapy)
Patients receive fludarabine IV over 24 hours on days 0 and 1, cytarabine IV over 72 hours on days 2-4, and idarubicin IV over 15 minutes on days 0-2. G-CSF begins on day 6 and continues until blood counts recover. Patients also receive TIT on days -1 and 7, if CSF is not clear on day 10 of induction. Patients on both arms are reassessed on day 35. Those patients with M1 marrow proceed to intensification; all others are removed from the study. Intensification: See Detailed Description |
Drug: asparaginase
Other Names:
Drug: fludarabine phosphate Other Names:
Drug: therapeutic hydrocortisone Other Names:
Procedure: allogeneic bone marrow transplantation Other Names:
Biological: filgrastim Given SC
Other Names:
Drug: cytarabine Given IV or IT
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: thioguanine Given PO
Other Name: 6-TG Drug: methotrexate Given IT
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: busulfan Other Names:
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Experimental: Arm III (combination chemotherapy, aldesleukin)
Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
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Drug: daunorubicin hydrochloride
Other Names:
Biological: filgrastim Given SC
Other Names:
Drug: cytarabine Given IV or IT
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: thioguanine Given PO
Other Name: 6-TG Drug: etoposide Given IV
Other Names:
Biological: aldesleukin Other Names:
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Active Comparator: Arm IV (combination chemotherapy)
No further treatment
|
Drug: daunorubicin hydrochloride
Other Names:
Biological: filgrastim Given SC
Other Names:
Drug: cytarabine Given IV or IT
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: thioguanine Given PO
Other Name: 6-TG Drug: etoposide Given IV
Other Names:
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Experimental: Arm V (combination chemotherapy, radiotherapy)
Patients undergo radiotherapy to the chloroma 5 days a week for 2 weeks.
|
Drug: daunorubicin hydrochloride
Other Names:
Radiation: 3-dimensional conformal radiation therapy Other Names:
Biological: filgrastim Given SC
Other Names:
Drug: cytarabine Given IV or IT
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: thioguanine Given PO
Other Name: 6-TG Drug: etoposide Given IV
Other Names:
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- Proportions of patients achieving remission rate during induction therapy [ Time Frame: Up to 42 days ]
- Proportion of patients dying or with residual disease during induction therapy [ Time Frame: Up to 42 days ]
- Time to marrow recovery (induction phase) [ Time Frame: Up to 42 days ]
- Frequency of toxicities, including infectious complications (induction phase) [ Time Frame: Up to 42 days ]
- Marrow status [ Time Frame: At 14 days ]
- Percent of blasts [ Time Frame: At the end of induction therapy ]
- Complete remission at the end of consolidation therapy [ Time Frame: Up to 5 years ]
- Survival following consolidation [ Time Frame: Up to 5 years ]
- Event-free survival following consolidation [ Time Frame: Up to 5 years ]
- Overall survival (intensification) [ Time Frame: Up to 5 years ]
- EFS (intensification) [ Time Frame: Up to 5 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Histologically confirmed previously untreated acute myeloid leukemia (AML) in patients 1 month to 21 years of age
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Infants under 1 month with progressive disease eligible
- Supportive care may be given to confirm that the leukemia is not regressing prior to entry
- No acute promyelocytic leukemia (FAB M3)
- No acute undifferentiated leukemia (FAB M0)
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Histochemical verification of AML required by the following stains:
- Wright or Giemsa
- Peroxidase
- PAS
- Chloroacetate esterase
- Sudan black
- Nonspecific esterase (NSE) with and without fluoride (NaF) inhibition
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Combined NSE/NaF and butyrate inhibition or diagnosis of megakaryoblasticleukemia (FAB M7) should be supported by one of the following:
- CD41 reactivity
- Glycoprotein 1b reactivity
- Factor VIII-related antigen reactivity
- Platelet peroxidase on electron microscopy
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The following are also eligible:
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Myelodysplastic syndromes, including:
- Refractory anemia (RA) *
- RA with ringed sideroblasts (RARS) *
- RA with excess blasts (RAEB)
- RAEB in transformation (RAEBt)
- Chronic myelomonocytic leukemia (CMML)
- AML with monosomy 7
- Granulocytic sarcoma (chloroma) with or without marrow involvement
- Mixed lineage leukemia with 2 morphologically defined populations provided the predominant population is myeloid
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- No Downs syndrome
- No juvenile chronic myelogenous leukemia
- No Fanconi's anemia
- No secondary AML
- Performance status - Not specified
- No prior anticancer chemotherapy
- Prior topical or inhaled steroids for nonmalignant conditions allowed
- No prior anticancer radiotherapy
- No prior antileukemic therapy

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): NCT00002798
United States, California | |
Children's Oncology Group | |
Arcadia, California, United States, 91006-3776 |
Principal Investigator: | Beverly Lange | Children's Oncology Group |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002798 |
Other Study ID Numbers: |
NCI-2012-01834 2961 U10CA098543 ( U.S. NIH Grant/Contract ) CDR0000064883 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | January 16, 2013 |
Last Verified: | January 2013 |
Leukemia Leukemia, Myeloid, Acute Preleukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Leukemia, Monocytic, Acute Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute Anemia Myelodysplastic Syndromes Anemia, Refractory Anemia, Refractory, with Excess of Blasts Syndrome |
Disease Pathologic Processes Neoplasms by Histologic Type Neoplasms Hematologic Diseases Bone Marrow Diseases Precancerous Conditions Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Cytarabine Aldesleukin Dexamethasone Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate |