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

Not Applicable

• Conditions: Ph-negative Adult Acute Lymphoblastic Leukemia

• Registration Number: NCT01193933
• Lead Sponsor: National Research Center for Hematology, Russia

Brief Summary

1. 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

2. feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance.

3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU)

4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL

Detailed Description

1. 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.

2. "no interruptions" induction was performed in 48% of patients.

3. In 19% of patients the L-asparaginase therapy was stopped due to toxicity.

4. Autologous stem cell transplantation was done in 20% of T-cell ALL patients.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2016-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 321

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of adult ALL patients who tolerated the non-interrupted treatment	3 years	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

Secondary Outcome Measures

Name	Time	Method
Toxicity of prolonged L-asparaginase in adult patients	3 years	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

Trial Locations

Locations (1)

Russian Acute Lymphoblastic Leukemia Study group; 🇷🇺 Moscow, Russian Federation