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| Sponsored by: |
Dutch Childhood Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00015873 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective for treating infants with acute lymphoblastic leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
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Leukemia |
Drug: asparaginase Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisolone Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation |
Phase III |
| MedlinePlus related topics: | Bone Marrow Transplantation Cancer Leukemia, Childhood |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic Leukemia |
| Estimated Enrollment: | 350 |
| Study Start Date: | May 1999 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations |
Show 33 Study Locations |
| Dutch Childhood Oncology Group |
| Study Chair: | Rob Pieters, MD, MSC, PhD | Erasmus MC - Sophia Children's Hospital |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Pieters R, Schrappe M, De Lorenzo P, Hann I, De Rossi G, Felice M, Hovi L, LeBlanc T, Szczepanski T, Ferster A, Janka G, Rubnitz J, Silverman L, Stary J, Campbell M, Li CK, Mann G, Suppiah R, Biondi A, Vora A, Valsecchi MG. A treatment protocol for infants younger than 1 year with acute lymphoblastic leukaemia (Interfant-99): an observational study and a multicentre randomised trial. Lancet. 2007 Jul 21;370(9583):240-50.
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Pieters R, Schrappe M, de Lorenzo P, et al.: Outcome of infants less than one year of age with acute lymphoblastic leukemia treated with the Interfant-99 protocol. [Abstract] Blood 108 (11): A-145, 2006.
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| Study ID Numbers: | CDR0000068529, ICU-INTERFANT99, UKCCSG-LK-1999-05, EU-20063, EU-20588 |
| First Received: | May 6, 2001 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00015873 |
| Health Authority: | United States: Federal Government |
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