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

Sponsor

National Research Center for Hematology, Russia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01193933

Collaborator

(none)

321

Enrollment

Location

157

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ph-negative Adult Acute Lymphoblastic Leukemia	Procedure: autologous HSCT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

321 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Nov 1, 2008

Actual Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Russian Acute Lymphoblastic Leukemia Study group	Moscow		Russian Federation

Sponsors and Collaborators

National Research Center for Hematology, Russia

Investigators

Study Chair: Valeri G Savchenko, Professor, National Research Center for Hematology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elena N.Parovichnikova, MD PhD, National Research Center for Hematology, Russia

ClinicalTrials.gov Identifier:

NCT01193933

Other Study ID Numbers:

ALL-2009

First Posted:

Sep 2, 2010

Last Update Posted:

Mar 7, 2018

Last Verified:

Mar 1, 2018

Keywords provided by Elena N.Parovichnikova, MD PhD, National Research Center for Hematology, Russia

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Mar 7, 2018