Precursor Lymphoid NeoplasmsPhase 2NCT01665001
Personalized Therapy of Precursor Lymphoid Neoplasms
A Phase 2 study testing Treatment strategy: induction, consolidation, HSCT, maintenance in people with Precursor Lymphoid Neoplasms, run by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice at 1 site in Poland.
Trial summary
The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precursor Lymphoid Neoplasms
- What is being tested?
- Treatment strategy: induction, consolidation, HSCT, maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2012to Aug 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of PLN according to WHO 2008 classification
- Age ≥18 years
- Biological status allowing administration of induction therapy
- Informed patient consent form signed
Who cannot join
- Pregnancy
- Psychiatric diseases
- History of other malignancies
- HIV infection
- Active hepatitis
- Hypersensitivity to drugs used in induction
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, 44-101
Sebastian Giebel, MD, 0048322788523, sgiebel@io.gliwice.pl
About this study
Official title: Optimization of the Treatment of Adults With Precursor Lymphoid Neoplasms With Adjustment of the Type and Intensity of the Therapy for Age, Status of Minimal Residual Disease, Genetic and Phenotypic Features
The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms
Read the detailed description
Between 1997-2010 the PALG run three prospective studies. In the most recent PLAG 5-2007 protocol attempts have been made to individualize treatment. In particular, stratification to high and standard risk group was based on both conventional clinical criteria and the level of MRD after induction and consolidation. Patients with unsatisfactory response were referred for allogeneic hematopoietic stem cell transplantation (alloHSCT). Interim analysis showed significant improvement compared to previous PALG 4-2002 protocol with regard to both overall survival and leukemia-free survival. The reasons of failure were relapses and non-relapse mortality (NRM) associated with alloHSCT.
In the current protocol we intend to further adjust the therapy for individual patients needs. We assume that this way we will be able to reduce the risk of relapse and NRM and improve the cure rate. All patients will receive multiagent induction and consolidation chemotherapy. The type and intensity of the therapy, as well as indications for allogeneic and autologous HSCT will depend on age, status of MRD, immunophenotype and the presence of BCR/ABL fusion gene.
- Conditions
- Precursor Lymphoid Neoplasms
- Being tested
- Treatment strategy: induction, consolidation, HSCT, maintenance
- Keywords
- Acute lymphoblastic leukemia, Induction, Consolidation, Minimal residual disease, Hematopoietic stem cell transplantation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment strategy: induction, consolidation, HSCT, maintenanceOther
Patients <55 years Ph-neg.: induction (daunorubicin, prednisone, vincristin, PEG-asparaginase), 2nd induction (if non-remission or MRD>0.1%; FLAM, MiniFLAM or FLAM-CAMP dependent on age and phenotype), consolidation (methotrexate, etoposide, cytarabine, cyclophosphamide, PEG-asparaginase). If MRD <0.01%: autoHSCT + maintenance (mercaptopurine, methotrexate) or multiagent maintenance (additionally daunorubicin, vincristin, prednisone); remaining patients: alloHSCT. Prophylaxis of leptomeningeal involvement: liposomal cytarabine intrathecally.
Patients >55 years, Ph-neg.: as above, reduced doses. AlloHSCT with reduced conditioning.
Patients Ph-pos.: as above, reduced doses in combination with continues imatinib. All intended for alloHSCT.
| Study group | Role | What they receive |
|---|---|---|
| Multiagent induction-consolidation | Experimental | Induction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms Receives: Other: Treatment strategy: induction, consolidation, HSCT, maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: three years
Secondary outcomes (1)
Leukemia-free survival
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2016 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Precursor Lymphoid NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Adult Leukemia Group
- Responsible party
- Sponsor
- Investigators
- Sebastian Giebel, MD, Principal investigator, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665001
- Sponsor's protocol ID
- PALG ALL6
- Status last verified
- Aug 2012
- First submitted
- 11 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holowiecki J, Krawczyk-Kulis M, Giebel S, Jagoda K, Stella-Holowiecka B, Piatkowska-Jakubas B, Paluszewska M, Seferynska I, Lewandowski K, Kielbinski M, Czyz A, Balana-Nowak A, Krol M, Skotnicki AB, Jedrzejczak WW, Warzocha K, Lange A, Hellmann A. Status of minimal residual disease after induction predicts outcome in both standard and high-risk Ph-negative adult acute lymphoblastic leukaemia. The Polish Adult Leukemia Group ALL 4-2002 MRD Study. Br J Haematol. 2008 Jun;142(2):227-37. doi: 10.1111/j.1365-2141.2008.07185.x. Epub 2008 May 19.
PubMed 18492099
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Treatment of Adults With Precursor Lymphoid Neoplasms With Adjustment of the Type and Intensity of the Therapy for Age, Status of Minimal Residual Disease, Genetic and Phenotypic Features
- ClinicalTrials.gov ID
- NCT01665001
- Acronym / sponsor ID
- PALG ALL6
- Conditions
- Precursor Lymphoid Neoplasms
- Keywords
- Acute lymphoblastic leukemia, Induction, Consolidation, Minimal residual disease, Hematopoietic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, GliwiceUniversity, hospital or other
- Collaborators
- Polish Adult Leukemia Group
- Study start
- Aug 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 15 Aug 2012 (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.
The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms
Detailed description
Between 1997-2010 the PALG run three prospective studies. In the most recent PLAG 5-2007 protocol attempts have been made to individualize treatment. In particular, stratification to high and standard risk group was based on both conventional clinical criteria and the level of MRD after induction and consolidation. Patients with unsatisfactory response were referred for allogeneic hematopoietic stem cell transplantation (alloHSCT). Interim analysis showed significant improvement compared to previous PALG 4-2002 protocol with regard to both overall survival and leukemia-free survival. The reasons of failure were relapses and non-relapse mortality (NRM) associated with alloHSCT.
In the current protocol we intend to further adjust the therapy for individual patients needs. We assume that this way we will be able to reduce the risk of relapse and NRM and improve the cure rate. All patients will receive multiagent induction and consolidation chemotherapy. The type and intensity of the therapy, as well as indications for allogeneic and autologous HSCT will depend on age, status of MRD, immunophenotype and the presence of BCR/ABL fusion gene.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiagent induction-consolidation | Experimental | Other: Treatment strategy: induction, consolidation, HSCT, maintenanceInduction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- New diagnosis of PLN according to WHO 2008 classification
- Age ≥18 years
- Biological status allowing administration of induction therapy
- Informed patient consent form signed
Key exclusion criteria (6 listed)
- Pregnancy
- Psychiatric diseases
- History of other malignancies
- HIV infection
- Active hepatitis
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 |
|---|---|---|
| Treatment strategy: induction, consolidation, HSCT, maintenancePatients <55 years Ph-neg.: induction (daunorubicin, prednisone, vincristin, PEG-asparaginase), 2nd induction (if non-remission or MRD>0.1%; FLAM, MiniFLAM or FLAM-CAMP dependent on age and phenotype), consolidation (methotrexate, etoposide, cytarabine, cyclophosphamide, PEG-asparaginase). If MRD <0.01%: autoHSCT + maintenance (mercaptopurine, methotrexate) or multiagent maintenance (additionally daunorubicin, vincristin, prednisone); remaining patients: alloHSCT. Prophylaxis of leptomeningeal involvement: liposomal cytarabine intrathecally. Patients >55 years, Ph-neg.: as above, reduced doses. AlloHSCT with reduced conditioning. Patients Ph-pos.: as above, reduced doses in combination with continues imatinib. All intended for alloHSCT. | Other | Multiagent induction-consolidation |
Primary outcome
Overall survival
Time frame: three years
1 secondary outcome
Leukemia-free survival
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
- Background: PubMed 18492099Holowiecki J, Krawczyk-Kulis M, Giebel S, Jagoda K, Stella-Holowiecka B, Piatkowska-Jakubas B, Paluszewska M, Seferynska I, Lewandowski K, Kielbinski M, Czyz A, Balana-Nowak A, Krol M, Skotnicki AB, Jedrzejczak WW, Warzocha K, Lange A, Hellmann A. Status of minimal residual disease after induction predicts outcome in both standard and high-risk Ph-negative adult acute lymphoblastic leukaemia. The Polish Adult Leukemia Group ALL 4-2002 MRD Study. Br J Haematol. 2008 Jun;142(2):227-37. doi: 10.1111/j.1365-2141.2008.07185.x. Epub 2008 May 19.
- The Polish Adult Leukemia GoupLink provided by the sponsor.
Related trials for Precursor Lymphoid Neoplasms
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
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.
Sebastian Giebel, MD principal investigator
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment strategy: induction, consolidation, HSCT, maintenance in people with Precursor Lymphoid Neoplasms, run by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice at 1 site in Poland.
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 6 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 17 Aug 2012. 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 Poland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sebastian Giebel, MD (0048322788523, sgiebel@io.gliwice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: three 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 NCT01665001, which also lists 1 linked publication.
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 17 Aug 2012.