Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-30 @ 7:29 AM
Study NCT ID:
NCT01193933
Status:
UNKNOWN
Last Update Posted:
2018-03-07
First Post:
2010-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment
Sponsor:
National Research Center for Hematology, Russia
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: