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

Ph-negative Adult Acute Lymphoblastic Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01193933
• Other study ID #: ALL-2009
• Status: Active, not recruiting
• Phase: N/A
• First received: August 31, 2010
• Last updated: March 6, 2018
• Start date: November 2008
• Est. completion date: December 2021

Study information

• Verified date: March 2018
• Source: National Research Center for Hematology, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 321
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Ph-negative Adult Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Procedure:
• autologous HSCT
T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support

Locations

Country	Name	City	State
Russian Federation	Russian Acute Lymphoblastic Leukemia Study group	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Hematology, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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