Precursor Cell Lymphoblastic Leukemia-LymphomaNCT03462095
De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)
A study testing Autologous HSCT in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial summary
No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- Autologous HSCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2017to 1 Dec 2022
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-55 yy, newly diagnosed non-treated Ph-negative ALL
Who cannot join
- age > 55 yy, Ph-positivity, relapsed|refractory ALL, pretreated ALL
Trial locations and contacts
1 site in 1 country.
Olga A Gavrilina, M.D. contact
Russia1 site, 1 recruiting
- Recruiting
National Research Center for Hematology
Moscow, 125167
Elena N Parovichnikova, MD PhD, +7(495)6124313, elenap@blood.ru
About this study
Official title: Non-intensive But Non-interruptive Treatment of Adult Ph-negative Acute Lymphoblastic Leukemia With Randomization for Maintenance or Autologous Hematopoietic Stem Cell Transplantation (HSCT) Followed by Maintenance in T-cell ALL Patients
No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.
Read the detailed description
- 7 days prednisolone prephase
- 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,
- instead of 2 Cph injections during induction,
- instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases
- After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT
- Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
- After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT
- Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning
- 2 years maintenance for all patients
- 21 TIT through the whole treatment with higher intensity during induction|consolidation
- Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT
- Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)
- Being tested
- Autologous HSCT
- 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
After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance
| Study group | Role | What they receive |
|---|---|---|
| no Auto-HSCT | No intervention | After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance |
| Auto-HSCT | Experimental | After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance Receives: Procedure: Autologous HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Impact of autologous HSCT on DFS in T-cell ALL patients
Measured: 5-years
Secondary outcomes (2)
MRD-negativity after consolidation
Minimal Residual Disease clearance on non-intensive but non-interruptive treatment
Measured: 6 months
Overall survival
Impact of de-escalated approach on OS
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study startJan 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor Cell Lymphoblastic Leukemia-LymphomaStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Valeriy V Savchenko, Academician, Study director, National Research Center for hematology, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462095
- Sponsor's protocol ID
- ALL--2016
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Each participating site has its on-line access to WEB-data base
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-intensive But Non-interruptive Treatment of Adult Ph-negative Acute Lymphoblastic Leukemia With Randomization for Maintenance or Autologous Hematopoietic Stem Cell Transplantation (HSCT) Followed by Maintenance in T-cell ALL Patients
- ClinicalTrials.gov ID
- NCT03462095
- Acronym / sponsor ID
- ALL--2016
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 12 Mar 2018 (actual)
- 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.
No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.
Detailed description
- 7 days prednisolone prephase
- 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,
- instead of 2 Cph injections during induction,
- instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases
- After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT
- Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
- After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT
- Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning
- 2 years maintenance for all patients
- 21 TIT through the whole treatment with higher intensity during induction|consolidation
- Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT
- Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no Auto-HSCT | No intervention | –After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance |
| Auto-HSCT | Experimental | Procedure: Autologous HSCTAfter completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-55 yy, newly diagnosed non-treated Ph-negative ALL
Key exclusion criteria (1 listed)
- age > 55 yy, Ph-positivity, relapsed|refractory ALL, pretreated ALL
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 HSCTAfter the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance | Procedure or surgery | Auto-HSCT |
Primary outcome
Disease-free survival
Time frame: 5-years
Impact of autologous HSCT on DFS in T-cell ALL patients
2 secondary outcomes
MRD-negativity after consolidation
Time frame: 6 months
Overall survival
Time frame: 5-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: Yes. Each participating site has its on-line access to WEB-data base
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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.
Olga A Gavrilina, M.D. contact
Valeriy V Savchenko, Academician study director
National Research Center for hematology, Moscow, Russia
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 Precursor Cell Lymphoblastic Leukemia-Lymphoma, 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 1 inclusion and 1 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 13 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?
Contact Elena N Parovichnikova, MD,PhD (+79161252623, elenap@blood.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2018.