Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment

Study Overview
=================
Brief Summary
-----------------
evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more feasibility for adults of no interruptions protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance. tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU) feasibility and efficacy of autologous stem cell transplantation for T-cell ALL

Detailed Description
-----------------
The blast count in b/m after 7 days of prednisolone >25% was shown in 64% of patients. The substitution of prednisolone by dexamethasone did not influence survival. no interruptions induction was performed in 48% of patients. In 19% of patients the L-asparaginase therapy was stopped due to toxicity. Autologous stem cell transplantation was done in 20% of T-cell ALL patients.

Official Title
-----------------
Multicenter Clinical Trial for Adult Ph-negative ALL. Evaluation of the Impact of the Prolonged L-asparaginase Therapy During Continuous Treatment With Modification of Cytostatic Drugs Doses Depending on Myelosuppression Severity.

Conditions
-----------------
Ph-negative Adult Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Procedure: autologous HSCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ph-negative precursors ALL age 15-55 years nontreated Eastern Cooperative Oncology Group criterion status 0-3 Exclusion Criteria: B-mature ALL Ph-positivity pretreatment Eastern Cooperative Oncology Group criterion status 4

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: autologous HSCT|T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adult ALL patients who tolerated the non-interrupted treatment | Number of patients who finished the protocol without any deviation, who were off the protocol due to toxicity, in whom the treatment schedule was modified and respectively the antileukemia efficacy in those subgroups | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of prolonged L-asparaginase in adult patients | Number of patients who tolerated the scheduled L-asparaginase by dose and time sequence, proportion of patients shifted to PEG-asparaginase, in whom L-asparaginase was stopped and, respectively, the survival without leukemia of those patients | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult ALL, Ph-negative, dexamethasone, L-asparaginase