Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00015873

First received: May 6, 2001

Last updated: November 11, 2010

Last verified: October 2006

History of Changes

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
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 3

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Chronic Lymphocytic Leukemia Leukemia Steroids

Drug Information available for: Dexamethasone Cyclophosphamide Prednisolone Mercaptopurine Prednisolone acetate Prednisone Methylprednisolone acetate Busulfan Methotrexate Methylprednisolone Prednisolone sodium phosphate Cytarabine Thioguanine Prednisolone phosphate Dexamethasone acetate Leucovorin calcium Prednisolone sodium succinate Vincristine sulfate Methylprednisolone sodium succinate Dexamethasone sodium phosphate Asparaginase Methotrexate sodium Daunorubicin Daunorubicin hydrochloride Etoposide Cyclosporine Levoleucovorin Etoposide phosphate Daunorubicin citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival at 3-4 years after diagnosis [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	May 1999

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Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of acute lymphoblastic leukemia (ALL)
- Newly diagnosed
- Morphological verification by cytochemistry and immunophenotyping
CNS or testicular leukemia at diagnosis allowed
Trisomy 21 allowed

PATIENT CHARACTERISTICS:

Age:

365 days or less

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for leukemia

Endocrine therapy:

At least 4 weeks since prior systemic corticosteroids
Prior inhaled steroids allowed

Radiotherapy:

No prior radiotherapy for leukemia

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015873

Show 33 Study Locations

Sponsors and Collaborators

Dutch Childhood Oncology Group

Investigators

Study Chair:

Rob Pieters, MD, MSC, PhD

Erasmus MC - Sophia Children's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Hempel G, Relling MV, de Rossi G, Stary J, De Lorenzo P, Valsecchi MG, Barisone E, Boos J, Pieters R. Pharmacokinetics of daunorubicin and daunorubicinol in infants with leukemia treated in the interfant 99 protocol. Pediatr Blood Cancer. 2010 Mar;54(3):355-60.

Mann G, Attarbaschi A, Schrappe M, De Lorenzo P, Peters C, Hann I, De Rossi G, Felice M, Lausen B, Leblanc T, Szczepanski T, Ferster A, Janka-Schaub G, Rubnitz J, Silverman LB, Stary J, Campbell M, Li CK, Suppiah R, Biondi A, Vora A, Valsecchi MG, Pieters R; Interfant-99 Study Group. Improved outcome with hematopoietic stem cell transplantation in a poor prognostic subgroup of infants with mixed-lineage-leukemia (MLL)-rearranged acute lymphoblastic leukemia: results from the Interfant-99 Study. Blood. 2010 Oct 14;116(15):2644-50. Epub 2010 Jun 30.

Lönnerholm G, Valsecchi MG, De Lorenzo P, Schrappe M, Hovi L, Campbell M, Mann G, Janka-Schaub G, Li CK, Stary J, Hann I, Pieters R; Interfant-99 study group. Pharmacokinetics of high-dose methotrexate in infants treated for acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 May;52(5):596-601.

van der Linden MH, Valsecchi MG, De Lorenzo P, Möricke A, Janka G, Leblanc TM, Felice M, Biondi A, Campbell M, Hann I, Rubnitz JE, Stary J, Szczepanski T, Vora A, Ferster A, Hovi L, Silverman LB, Pieters R. Outcome of congenital acute lymphoblastic leukemia treated on the Interfant-99 protocol. Blood. 2009 Oct 29;114(18):3764-8. Epub 2009 Aug 5.

Van der Velden VH, Corral L, Valsecchi MG, Jansen MW, De Lorenzo P, Cazzaniga G, Panzer-Grümayer ER, Schrappe M, Schrauder A, Meyer C, Marschalek R, Nigro LL, Metzler M, Basso G, Mann G, Den Boer ML, Biondi A, Pieters R, Van Dongen JJ; Interfant-99 Study Group. Prognostic significance of minimal residual disease in infants with acute lymphoblastic leukemia treated within the Interfant-99 protocol. Leukemia. 2009 Jun;23(6):1073-9. Epub 2009 Feb 12.

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.

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.

ClinicalTrials.gov Identifier:	NCT00015873 History of Changes
Other Study ID Numbers:	CDR0000068529, ICU-INTERFANT99, UKCCSG-LK-1999-05, EU-20063, EU-20588
Study First Received:	May 6, 2001
Last Updated:	November 11, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Busulfan
Cyclophosphamide

Cyclosporins
Cyclosporine
Asparaginase
Daunorubicin
Dexamethasone
Etoposide
Prednisolone
Methylprednisolone Hemisuccinate
Prednisone
Vincristine
BB 1101
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone

ClinicalTrials.gov processed this record on May 16, 2013

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