Ph-negative Adult Acute Lymphoblastic LeukemiaNCT01193933
Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment
A study testing autologous HSCT in people with Ph-negative Adult Acute Lymphoblastic Leukemia, run by National Research Center for Hematology, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Ph-negative Adult Acute Lymphoblastic Leukemia
- What is being tested?
- autologous HSCT
- Type of treatment
- Surgery or procedure
- How many people
- 321 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2008to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ph-negative precursors ALL
- age 15-55 years
- nontreated
- Eastern Cooperative Oncology Group criterion status 0-3
Who cannot join
- B-mature ALL
- Ph-positivity
- pretreatment
- Eastern Cooperative Oncology Group criterion status 4
Trial locations and contacts
1 site in 1 country.
About this study
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.
- 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
Read the 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.
- Being tested
- autologous HSCT
- Keywords
- adult ALL, Ph-negative, dexamethasone, L-asparaginase
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous HSCTProcedure or surgery
T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2016
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ph-negative Adult Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Elena N.Parovichnikova, National Research Center for Hematology, Russia
- Investigators
- Valeri G Savchenko, Professor, Study chair, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193933
- Sponsor's protocol ID
- ALL-2009
- Status last verified
- Mar 2018
- First submitted
- 31 Aug 2010
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33676165Parovichnikova 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.
PubMed 31597157Piskunova 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.
PubMed 30701920Parovichnikova 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.
PubMed 28766535Parovichnikova 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.
PubMed 26390721
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01193933
- Acronym / sponsor ID
- ALL-2009
- Keywords
- adult ALL, Ph-negative, dexamethasone, L-asparaginase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- Nov 2008
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Ph-negative precursors ALL
- age 15-55 years
- nontreated
- Eastern Cooperative Oncology Group criterion status 0-3
Key exclusion criteria (4 listed)
- B-mature ALL
- Ph-positivity
- pretreatment
- Eastern Cooperative Oncology Group criterion status 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous HSCTT-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Toxicity of prolonged L-asparaginase in adult patients
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 33676165Parovichnikova 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.
- Derived from this study: PubMed 31597157Parovichnikova 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.
- Derived from this study: PubMed 30701920Piskunova 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.
- Derived from this study: PubMed 28766535Parovichnikova 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.
- Derived from this study: PubMed 26390721Parovichnikova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeri G Savchenko, Professor study chair
National Research Center for Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous HSCT in people with Ph-negative Adult Acute Lymphoblastic Leukemia, run by National Research Center for Hematology, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adult ALL patients who tolerated the non-interrupted treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01193933, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.