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Spots Global Cancer Trial Database for Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

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Trial Identification

Brief Title: Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

Official Title: Young Adult With Acute Lymphoblastic Leukemia (ALL) : a Multicentric Protocol. GRAALL 2005 : T ALL or B ALL Non Ph GRAALL 2005 R : B ALL Non Ph CD20+ GRAAPH 2005 : ALL Ph

Study ID: NCT00327678

Study Description

Brief Summary: This study is a multicenter trial of treatment for young ALL patients. All ALL patients will receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then, patients will be included into 3 specific trials according to biological features (immunophenotype, cytogenetics, and molecular biology). Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005: * T ALL or B ALL non Ph (N=810 patients planned). * GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned). * GRAAPH 2005: ALL Ph+ (N=270 patients planned)

Detailed Description: GRAALL 2005: T ALL or B ALL non Ph Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification. (N=810 patients planned) GRAALL 2005 R: B ALL non Ph CD20+ Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification. Randomization between Mabthera (rituximab) or no Mabthera during all induction and consolidation courses.(N=220 patients planned) Allogenic transplantation will be performed depending on unfavourable risk factors. GRAAPH 2005: ALL Ph Randomization between an imatinib-based induction and a chemotherapy + imatinib induction. (N=270 patients planned) Allogenic transplantation will be systematically performed in the presence of related or unrelated donors. Autologous transplantation could be performed in the absence of a donor in case of Molecular Residual Disease (MRD) ≤ 10-4. Consolidation therapy will be performed in the absence of a donor in case of MRD \> 10-4.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL -, Lyon, , France

Contact Details

Name: HERVE DOMBRET, MD, PHD

Affiliation: GRAALL Group

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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