Clinical trial · Interventional

Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia

AIEOP LLA 2000 Multicenter Study for the Diagnosis and Treatment of Childhood Acute Lymphoblastic Leukemia

NCT00613457CI-TRIAL-00016615AIEOP LLA 2000completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia. PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90

Interventions

Interventions (14)

Intervention	Type	Mapped drug	Match
asparaginase	Drug	Asparaginase	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
cytarabine	Drug	Cytarabine	ALIAS
daunorubicin	Drug	Daunorubicin	ALIAS
dexamethasone	Drug	Dexamethasone	ALIAS
doxorubicin	Drug	Doxorubicin	ALIAS
Etoposide	Drug	Etoposide	ALIAS
Ifosfamide	Drug	Ifosfamide	ALIAS

Design

Arms and outcomes

Arms (7)

type
EXPERIMENTAL
label
I
description
o Arm I (closed to accrual as of 6/30/2006): Patients receive prednisone (PRED) on days 8-28.
interventionNames
1. Drug: asparaginase
2. Drug: cyclophosphamide
3. Drug: cytarabine
4. Drug: daunorubicin
5. Drug: mercaptopurine
6. Drug: Methotrexate
7. Drug: prednisone
8. Drug: Vincristine
type
EXPERIMENTAL
label
II
description
o Arm II (closed to accrual as of 6/30/2006): Patients receive dexamethasone (DEXA) on days 8-28.
interventionNames
1. Drug: dexamethasone
2. Drug: asparaginase
3. Drug: cyclophosphamide
4. Drug: cytarabine
5. Drug: daunorubicin

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 1 Year
Maximum age: 17 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically confirmed acute lymphoblastic leukemia (ALL)
* No secondary ALL
* More than 4 weeks since prior chemotherapy
* More than 4 weeks since prior steroids

Exclusion Criteria:

* Prior disease that would preclude treatment with chemotherapy

References

Publications (8)

DERIVEDHeilmann J, Vieth S, Moricke A, Attarbaschi A, Barbaric D, Bodmer N, Colombini A, Dalla-Pozza L, Elitzur S, Izraeli S, Mann G, Niggli F, Silvestri D, Stary J, Rizzari C, Valsecchi MG, Zapotocka E, Zimmermann M, Cario G, Schrappe M, Conter V. Effect of two additional doses of intrathecal methotrexate during induction therapy on serious infectious toxicity in pediatric patients with acute lymphoblastic leukemia. Haematologica. 2023 Dec 1;108(12):3278-3286. doi: 10.3324/haematol.2022.281788. PMID 37021527
DERIVEDCario G, Leoni V, Conter V, Attarbaschi A, Zaliova M, Sramkova L, Cazzaniga G, Fazio G, Sutton R, Elitzur S, Izraeli S, Lauten M, Locatelli F, Basso G, Buldini B, Bergmann AK, Lentes J, Steinemann D, Gohring G, Schlegelberger B, Haas OA, Schewe D, Buchmann S, Moericke A, White D, Revesz T, Stanulla M, Mann G, Bodmer N, Arad-Cohen N, Zuna J, Valsecchi MG, Zimmermann M, Schrappe M, Biondi A. Relapses and treatment-related events contributed equally to poor prognosis in children with ABL-class fusion positive B-cell acute lymphoblastic leukemia treated according to AIEOP-BFM protocols. Haematologica. 2020 Jul;105(7):1887-1894. doi: 10.3324/haematol.2019.231720. Epub 2019 Oct 10. PMID 31601692
DERIVEDSchrappe M, Bleckmann K, Zimmermann M, Biondi A, Moricke A, Locatelli F, Cario G, Rizzari C, Attarbaschi A, Valsecchi MG, Bartram CR, Barisone E, Niggli F, Niemeyer C, Testi AM, Mann G, Ziino O, Schafer B, Panzer-Grumayer R, Beier R, Parasole R, Gohring G, Ludwig WD, Casale F, Schlegel PG, Basso G, Conter V. Reduced-Intensity Delayed Intensification in Standard-Risk Pediatric Acute Lymphoblastic Leukemia Defined by Undetectable Minimal Residual Disease: Results of an International Randomized Trial (AIEOP-BFM ALL 2000). J Clin Oncol. 2018 Jan 20;36(3):244-253. doi: 10.1200/JCO.2017.74.4946. Epub 2017 Nov 17. PMID 29148893
DERIVEDMoricke A, Zimmermann M, Valsecchi MG, Stanulla M, Biondi A, Mann G, Locatelli F, Cazzaniga G, Niggli F, Arico M, Bartram CR, Attarbaschi A, Silvestri D, Beier R, Basso G, Ratei R, Kulozik AE, Lo Nigro L, Kremens B, Greiner J, Parasole R, Harbott J, Caruso R, von Stackelberg A, Barisone E, Rossig C, Conter V, Schrappe M. Dexamethasone vs prednisone in induction treatment of pediatric ALL: results of the randomized trial AIEOP-BFM ALL 2000. Blood. 2016 Apr 28;127(17):2101-12. doi: 10.1182/blood-2015-09-670729. Epub 2016 Feb 17.