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

NCT ID: NCT01193933

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2021-12-31

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.

Conditions

Ph-negative Adult Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

autologous HSCT

T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Center for Hematology, Russia

NETWORK

Sponsor Role: lead

Responsible Party

Elena N.Parovichnikova

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valeri G Savchenko, Professor

Role: STUDY_CHAIR

National Research Center for Hematology

Locations

Russian Acute Lymphoblastic Leukemia Study group

Moscow, , Russia

Countries

Russia

References

Parovichnikova EN, Troitskaya VV, Gavrilina OA, Sokolov AN, Kokhno AV, Klyasova GA, Kuzmina LA, Galstyan GM, Makhinya SA, Latyshkevich OA, Kaporskaya TS, Lapin VA, Chabaeva YA, Kulikov SM, Savchenko VG; for Russian Acute Lymphoblastic Leukemia group. The outcome of Ph-negative acute lymphoblastic leukemia presenting during pregnancy and treated on the Russian prospective multicenter trial RALL-2009. Leuk Res. 2021 May;104:106536. doi: 10.1016/j.leukres.2021.106536. Epub 2021 Feb 14.

Reference Type: DERIVED

PMID: 33676165 (View on PubMed)

Parovichnikova E, Troitskaya V, Sokolov A, Gavrilina O, Akhmerzaeva Z, Kuzmina L, Kliasova G, Chabaeva J, Kulikov S, Bondarenko S, Baranova O, Samoilova O, Kaplanov K, Minaeva N, Savchenko V; Russian Acute Lymphoblastic Leukemia Group. Can Less Intensive Chemotherapy and an Autotransplant Cure Adult T-Cell Acute Lymphoblastic Leukemia? Acta Haematol. 2020;143(2):131-139. doi: 10.1159/000502435. Epub 2019 Oct 9.

Reference Type: DERIVED

PMID: 31597157 (View on PubMed)

Piskunova IS, Obukhova TN, Parovichnikova EN, Kulikov SM, Troitskaya VV, Gavrilina OA, Savchenko VG. Structure and significance of cytogenetic abnormalities in adult patients with Ph-negative acute lymphoblastic leukemia. Ter Arkh. 2018 Aug 17;90(7):30-37. doi: 10.26442/terarkh201890730-37.

Reference Type: DERIVED

PMID: 30701920 (View on PubMed)

Parovichnikova EN, Troitskaya VV, Sokolov AN, Bondarenko SN, Gavrilina OA, Baskhaeva GA, Biderman BV, Lukyanova IA, Kuz'mina LA, Klyasova GA, Kravchenko SK, Gribanova EO, Zvonkov EE, Akhmerzaeva ZK, Baranova OY, Kaporskaya TS, Ryltsova TV, Zotina EN, Zinina EE, Samoilova OS, Kaplanov KD, Gavrilova LV, Konstantinova TS, Lapin VA, Pristupa AS, Eluferyeva AS, Obukhova TN, Piskunova IS, Gal'tseva IV, Dvirnyk VN, Rusinov MA, Kulikov SM, Savchenko VG. [Adult B-cell acute lymphoblastic leukemias: Conclusions of the Russian prospective multicenter study ALL-2009]. Ter Arkh. 2017;89(7):10-17. doi: 10.17116/terarkh201789710-17. Russian.

Reference Type: DERIVED

PMID: 28766535 (View on PubMed)

Parovichnikova EN, Kuzmina LA, Mendeleeva LP, Klyasova GA, Troitskaya VV, Sokolov AN, Akhmerzaeva ZK, Kravchenko SK, Gribanova EO, Zvonkov EE, Bondarenko SN, Baranova OY, Ryltsova TV, Gavrilova LV, Zinina EE, Pristupa AS, Kaporskaya TS, Minaeva NV, Samoilova OS, Konstantinova TS, Lapin VA, Kaplanov KD, Kryuchkova IV, Nizamutdinova AS, Klimovich AV, Borisenkova EA, Moskov VI, Gaponova TV, Obukhova TV, Galtseva IV, Rusinov MA, Kulikov SM, Savchenko VG. [Autologous hematopoietic stem cell transplantation as late high-dose consolidation in adult patients with T-cell lymphoblastic leukemias: Results of a Russian multicenter study]. Ter Arkh. 2015;87(7):15-25. doi: 10.17116/terarkh201587715-25. Russian.

Reference Type: DERIVED

PMID: 26390721 (View on PubMed)

Other Identifiers

ALL-2009

Identifier Type: -

Identifier Source: org_study_id