- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02072811
Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia (PALG-AML2012)
Evaluation of the Efficacy of Induction-consolidation Treatment Using a Double Induction in Patients With AML <60 Years Old, Depending on the Percentage of Blasts in the 14 Day, Residual Disease and Leukemic Hematopoietic Cells
In view of the diversity of the biology of acute myeloid leukemia (AML) therapy in individual patients must be individualized. One of the tools for this is molecular-cytogenetic stratification. It divides patients into five categories (prognostic groups): Favorable, Intermediate-1, Intermediate-2, Adverse and Very adverse risk. After remission proceedings are tailored depending on prognostic determined groups.
Research of PALG group in the application in the second line regimen CLAG and CLAG-M proved high effectiveness of this treatment with low toxicity. Considering experience of PALG groups, it seems that the use of the schema CLAG early as the second induction therapy is a viable treatment option.
Study Overview
Status
Conditions
Detailed Description
Patients with AML with one of 5 prognostic categories based on modified cytogenetic-molecular stratification (European Leukemia Net Prognostic System - ENL)
Favorable risk
t(8;21)(q22;q22); RUNX1-RUNX1T1 inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 Mutated NPM1 without FLT3-ITD (NK) Mutated CEBPA (NK)
Intermediate I risk
Mutated NPM1 with FLT3-ITD (NK) Wild-type NPM1 and FLT3-ITD (NK) Wild-type NPM1 without FLT3-ITD (NK)
Intermediate II risk
t(9;11)(p22;q22); MLLT3-MLL cytogenic abnormalities other than favorable or adverse
Adverse risk
Inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN-EVI1
Very adverse risk monosomal karyotype (MK): -5 or del(5q); -7; abnl(17p); complex karyotype
Goals:
- Evaluation of the impact of therapy tailored to the risk factors on outcome of AML patients aged ≤ 60.
- Evaluation of the possibility to improve the results of induction therapy through the use of early 2nd induction in patients with persistent leukemic infiltration of the bone marrow at the 14th day,
- Evaluation of the impact of the minimal residual disease (MRD) presence assessed by Immunophenotyping method, on the results of treatment of AML patients aged ≤ 60,
- Assessing the significance of monitoring the number of leukemic stem cells (LSC) in bone marrow and peripheral blood and their influence on clinical course and outcome of AML treatment,
- Assessment of the LSC determination usefulness in MRD monitoring in patients with AML,
- Evaluation of the prognostic significance of the expression of CXCR-4 on the surface of leukemic cells and their impact on the clinical course and outcome of AML - trying to select a group of patients who potentially would benefit from the use of chemosensitization with plerixafor,
- Evaluation of autologous HSCT effectiveness in consolidation therapy in AML patients from 3 following cytogenetic-molecular risk groups: Favorable, Intermediate I, Intermediate II,
- Comparison of the overall survive (OS) and leukemia-free survival after autologous and allogeneic HSCT in AML patients from Intermediate I and Intermediate II cytogenetic-molecular risk groups (biological randomization donor vs. donor).
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Agnieszka Wierzbowska, dr hab.n.med.
- Phone Number: +48426895191
- Email: agawierzbowska@wp.pl
Study Contact Backup
- Name: Agnieszka Pluta, dr n.med.
- Phone Number: +48426895191
- Email: agnieszka.pluta@op.pl
Study Locations
-
-
-
Lodz, Poland, 93-510
- Recruiting
- Copernicus Memorial Hospital
-
Principal Investigator:
- Agnieszka Wierzbowska, Dr hab. n. med.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult acute myeloid leukemia
- Age: ≥18 and ≤ 60
- Clinical condition of the patient allows to carry out induction therapy: ECOG performance status: ≤ 2 and the Hematopoietic Cell Transplant-Co-morbidity Index (HCT-I): ≤3
- Informed consent to participate in the study (ICF signed)
- The second early induction start criteria is in addition to the listed above, the percentage of the blasts on the level >10% on 7th day.
Exclusion Criteria:
- No informed consent for participation in the study, mental illness, which don't allow to obtain informed consent and conduct the treatment according to the protocol
- Pregnancy
- HIV infection
- Active cancer
- Active hepatitis virus infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Induction, DAC
The first stage of treatment. First DAC induction cycle is common to all patients (regardless of risk group). After completion of induction I occurs early assessment of bone marrow on the +14 day after the start of treatment (+7 day after completion of chemotherapy). |
Other Names:
|
Other: II early induction, CLAG
Patients with blasts in the bone marrow in D14> 10% receive early second induction (CLAG) which start form +16 day. Patients with blasts in the bone marrow in D14 ≤ 10% do not receive early second induction and are qualified to assess the response times on +28 day or after full morphology recovery (if it occurs before the +28 day |
Other Names:
|
Other: Consolidation, I HAM cycle
I induction cycle starts after complete remission (CR). - After I consolidation, patients from Intermediate I an Intermediate II group (ELN prognostic system): If compatible donor is present - allogeneic HSCT qualification after I or II consolidation. If compatible donor for allogeneic HSCT is not present - attempt to CD34+ mobilization for autologous SCT after II consolidation - After I consolidation, patients from Adverse risk group (ELN prognostic system): If compatible donor is present - immediate qualification for allogeneic HSCT. - Finding a donor should be initiated in all patients, at the latest after the end of I induction. In the first place, it should be checked whether the patient has a donor family, if not - searching start for an unrelated donor. For patients with no compatible donor for allogeneic HSCT - need to start searching for an alternative donor |
Other Names:
|
Other: II Consolidation HiDAraC
Patients from all 5 risk group receive second after first consolidation [Ara-C] Patient from Very adverse risk receive Ara-C + CLA (Cladribine). If it is needed - more intensive consolidation treatment with 2-Cda. Patients form Very adverse risk receive Maintenance treatment: Decitabine 20 mg/m2 60 min infusion iv (Intravenous injection) for 5 days every 6 weeks. Patients from Favorable, - Intermediate I an Intermediate II risk groups: CD34+ mobilization (HSCT qualification). |
• Ara-C 3g/m2 every 12h; 3h infusion iv on 1,3,5 days (+ mobilization of CD34+)
Other Names:
|
Other: Consolidation, III HiDAraC cycle
Patients from Favorable, Intermediate I an Intermediate II risk groups receive III consolidation or autologous HSCT (depends on results of mobilization). Patients from Adverse risk receive III Consolidation HiDAraC + Cladribina (CLA) If no CR: CLAG-M reinduction therapy and after CR - treatment according to protocol. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission after induction
Time Frame: 28 days
|
Outcome measure after induction: At +28 day after treatment or after full morphology recovery (if it occurs before the +28 day) Complete remission, according to Cheson's CR criteria:
After induction treatment, patients are qualified for one of the pro-remission treatment options, which is associated with cytogenetic-molecular risk groups, according to the modification of the molecular ELN / MDACC. Therapeutic decisions are being made according to cytogenetic-molecular stratification: Favorable, Intermediate-1, Intermediate-2, Adverse and Very adverse risk. |
28 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Adjuvants, Immunologic
- Antibiotics, Antineoplastic
- Lenograstim
- Cytarabine
- Daunorubicin
- Mitoxantrone
- Cladribine
Other Study ID Numbers
- PALG-AML2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myeloid Leukemia
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
Kronos BioActive, not recruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States, Spain
-
Massachusetts General HospitalExelixisCompletedRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
Clinical Trials on DAC
-
CopharosUnknownBreast CancerUnited States
-
CopharosUnknownCarcinoma, Non-Small-Cell Lung | Lung Neoplasms | Brain Neoplasms | Metastases, NeoplasmUnited States
-
National Institute of Neurological Disorders and...CompletedMultiple Sclerosis | Multiple Sclerosis, Relapsing-RemittingUnited States
-
Waisenmedizin e. V. Promoting Access to Essential...University of Freiburg; Waisenmedzin eV PACEM non-profit German NGO; German Medical... and other collaboratorsCompletedWound HealingAfghanistan
-
Universidad Autónoma de BucaramangaInstituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) and other collaboratorsUnknown
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruiting
-
University of LouisvilleWithdrawnAcute Myelogenous LeukemiaUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...ZonMw: The Netherlands Organisation for Health Research and DevelopmentTerminated
-
Shanghai Jiao Tong University School of MedicineCompleted
-
BiogenAbbVieCompletedRelapsing-Remitting Multiple SclerosisCzech Republic, Poland, Russian Federation, United Kingdom, Hungary, Ukraine, Germany, India