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4 cycles + 2 interphases +Hematopoietic Stem Cell Transplantation (SCT)

+ Post-SCT Maintenance

400 mg/12h per os D1 to D28 cycles 1-4 300 mg/12h per os D1-D14 interphase

1 g/m2 continuous Intravenous Infusion (CIV) D1 cycles 2 and 4 25 mg/m2 per os D1, D8 interphase

Age\<45 years: 3 mg/m2/12h D2, D3 cycles 2 and 4 Age\>=45 years: 1.5 mg/m2/12h D2, D3 cycles 2 and 4

Aracytine (Ara C)

5µg/kg/d (SC) D6 until neutrophils \> 1 G/L D15 cycles 1 and 3; D6 cycles 2 and 4

Granulocyte Colony-Stimulating Factor (G-CSF)

40 mg + methotrexate 15 mg + Aracytine (AraC) 40mg IT cycle 1: D1, D8, D15 IT cycles 2 and 4: D9 IT cycle 3: D1

Depomedrol

40 mg per os, D1-D2, D8-D9, D15-D16, D22-D23, cycles 1 and 3

2 mg total dose IV, D1 D8 D15 D22 cycles 1 and 3

300 mg/12h per os in post-SCT maintenance therapy for during at least 2 years

Imatinib

6 Mercaptopurine (6MP)

Hervé Dombret, MDPhD

Véronique Lhéritier

The Primary objective is to assess the non-inferiority of the experimental arm (arm B) compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the 4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL)

A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults

A Phase III Study, Randomized, to Evaluate the Reduction of Chemotherapy Intensity in Association With Nilotinib (Tasigna®) in Philadelphia Chromosome-positive (Ph+) ALL of Young Adults (18-59 Years Old) (GRAAPH-2014)

defined as a breakpoint cluster region (BCR)-Abelson (ABL) ratio \< 0.1% in the bone marrow sample of MRD4

mutations will be assessed by Reverse transcription Quantitative Polymerase Chain Reaction (RQ-PCR) sequencing in case of progression or relapse

Assistance Publique - Hôpitaux de Paris

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults	NCT02611492	Philadelphia Ch...	Nilotinib Methotrexate Aracytine (Ara ... Granulocyte Col... Depomedrol Dexamethasone Vincristine Imatinib 6 Mercaptopurin...	18 Years - 59 Years	Assistance Publique - Hôpitaux de Paris
A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults	NCT02611492	Philadelphia Ch...	Nilotinib Methotrexate Aracytine (Ara ... Granulocyte Col... Depomedrol Dexamethasone Vincristine Imatinib 6 Mercaptopurin...	18 Years - 59 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for depomedrol

Every month we try and update this database with for depomedrol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for depomedrol

Every month we try and update this database with for depomedrol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for depomedrol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.