Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01193933|
Recruitment Status : Unknown
Verified March 2018 by Elena N.Parovichnikova, National Research Center for Hematology, Russia.
Recruitment status was: Active, not recruiting
First Posted : September 2, 2010
Last Update Posted : March 7, 2018
- 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
|Condition or disease||Intervention/treatment||Phase|
|Ph-negative Adult Acute Lymphoblastic Leukemia||Procedure: autologous HSCT||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||321 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2021|
- Procedure: autologous HSCT
T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support
- Proportion of adult ALL patients who tolerated the non-interrupted treatment [ Time Frame: 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
- Toxicity of prolonged L-asparaginase in adult patients [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193933
|Russian Acute Lymphoblastic Leukemia Study group|
|Moscow, Russian Federation|
|Study Chair:||Valeri G Savchenko, Professor||National Research Center for Hematology|