AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 3PALG-AML2012NCT02072811

Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia

A Phase 3 study testing DAC, CLAG and Consolidation, I HAM cycle in people with Acute Myeloid Leukemia, run by dr hab. n. med. Agnieszka Wierzbowska at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
DAC, CLAG and Consolidation, I HAM cycle
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 sitePoland
Study dates
Feb 2014to Feb 2018
Phase
Phase 3
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Agnieszka Wierzbowska, dr hab.n.med. contact

+48426895191

agawierzbowska@wp.pl

Agnieszka Pluta, dr n.med. contact

+48426895191

agnieszka.pluta@op.pl

Poland1 site, 1 recruiting

  • Copernicus Memorial Hospital

    Lodz, 93-510

    Agnieszka Wierzbowska, Dr hab. n. med.

    Recruiting

Other trials in Poland

About this study

Official title: 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.

Read the 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).
Being tested
DAC, CLAG, Consolidation, I HAM cycle, II Consolidation HiDAraC, Consolidation, III HiDAraC cycle
Keywords
AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DACDrug

    Also called - Cladribine, - Cytosine arabinoside [Ara-C], - Daunorubicin

    • DNR 60 mg/m2 0,5h infusion iv on 1-3 days
    • 2-CdA 5 mg/m2 2h. infusion iv on 1-5 days
    • Ara-C 200 mg/m2 12h infusion iv 2h after end of infusion with 2CdA on 1-7 days

  • CLAGDrug

    Also called - Granulocyte-colony stimulating factor [G-CSF], - Cladribine, - Mitoxantrone, - Cytosine arabinoside [Ara C]

    • G-CSF 30MU sc, on 0-5 days
    • Mitoxantrone 10mg/m2 30 min infusion iv, on 1-3 days
    • Cladribine 5mg/m2 in 2h infusion iv, on 1-5 days
    • Ara-C 2000mg/m2 4h infusion iv, infusion start after 2h of Cladribine infusion end, on 1-5 day

  • Consolidation, I HAM cycleDrug

    Also called - Mitoxantrone, - Cytosine arabinoside [Ara-C]

    • Ara-C 3g/m2; 3h infusion iv every 12h on 1,2,3 days
    • Mitoxantrone 10mg/m2; 0,5h infusion iv on 3,4,5 days

  • II Consolidation HiDAraCDrug

    Also called - Cytosine arabinoside [Ara-C], - Cladribine

    • Ara-C 3g/m2 every 12h; 3h infusion iv on 1,3,5 days (+ mobilization of CD34+)

  • Consolidation, III HiDAraC cycleDrug

    Also called - Cytosine arabinoside [Ara-C], - 2-CdA [Cladribine, 2-Chlorodeoxyadenosine]

    • Ara-C 3g/m2 every 12h; 3h infusion iv on 1,3,5 days
    • 2-CdA 5 mg/m2 2h infusion iv on 1,3,5 days, 2h before Ara-C
Study groups in NCT02072811
Study groupRoleWhat they receive
Induction, DACOtherThe 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).
Receives: Drug: DAC
II early induction, CLAGOtherPatients 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
Receives: Drug: CLAG
Consolidation, I HAM cycleOtherI 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
Receives: Drug: Consolidation, I HAM cycle
II Consolidation HiDAraCOtherPatients 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).
Receives: Drug: II Consolidation HiDAraC
Consolidation, III HiDAraC cycleOtherPatients 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.
Receives: Drug: Consolidation, III HiDAraC cycle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission after induction

    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:

    • Lack of extramedullary infiltration,
    • Platelet count> 100 G / L,
    • Neutrophil count> 1.0 G / L,
    • Lack of blast cells in the blood,
    • Bone marrow blasts <5% in the cytomorphology.

    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.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionFeb 2018 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02072811
Sponsor's protocol ID
PALG-AML2012
Acronym
PALG-AML2012
Status last verified
Feb 2014
First submitted
24 Feb 2014
Last updated
27 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Pluta A, Robak T, Brzozowski K, Stepka K, Wawrzyniak E, Krawczynska A, Czemerska M, Szmigielska-Kaplon A, Grzybowska-Izydorczyk O, Nowicki M, Stelmach P, Kuydowicz M, Gromek T, Hus M, Helbig G, Grosicki S, Bodzenta E, Razny M, Wojcik K, Bolkun L, Kloczko J, Knopinska-Posluszny W, Piekarska A, Hellman A, Sobas M, Wrobel T, Patkowska E, Lech-Maranda E, Warzocha K, Holowiecki J, Giebel S, Wierzbowska A. Early induction intensification with cladribine, cytarabine, and mitoxantrone (CLAM) in AML patients treated with the DAC induction regimen: a prospective, non-randomized, phase II study of the Polish Adult Leukemia Group (PALG). Leuk Lymphoma. 2020 Mar;61(3):588-603. doi: 10.1080/10428194.2019.1678151. Epub 2019 Oct 29.

    PubMed 31661339

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DAC, CLAG and Consolidation, I HAM cycle in people with Acute Myeloid Leukemia, run by dr hab. n. med. Agnieszka Wierzbowska 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 5 inclusion and 5 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 27 Feb 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Agnieszka Wierzbowska, dr hab.n.med. (+48426895191, agawierzbowska@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission after induction (time frame: 28 days). 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 NCT02072811, 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 27 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in