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AMLPhase 2/3NCT05175508

Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

A Phase 2/3 study testing Azacitidine and all trans retinoic acid in people with AML and MDS, run by The First Affiliated Hospital of Soochow University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
AML, MDS, Old Age; Debility
What is being tested?
Azacitidine and all trans retinoic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
1 May 2021to 1 May 2023
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL) and myelodysplastic syndromes(2017 edition)
  • Be at least 18 years of age on day of signing informed consent
  • Not suitable for newly diagnosed patients with intensive chemotherapy
  • Not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation
  • The proportion of blast cells was below 50% in bone marrow
  • Total white blood cell (WBC) count ≤10,000/µL；Must be able to swallow tablets

Who cannot join

  • Malignant neoplasms with other progression
  • Serious mental illness uncooperative
  • Refusal to join the study

Trial locations and contacts

1 site in 1 country.

Han Yue, Ph.D contact

(0086)51267781856

hanyue@suda.edu.cn

Wu Depei, Ph.D contact

(0086)51267781856

drwudepei@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Yue Han, professor, +86 13901551669, hanyuesz@163.com

    Recruiting

Other trials in China

About this study

Official title: Azacitidine in Combination With or Without All-trans Retinoic Acid in Newly Diagnosed Unfit Acute Myeloid Leukemia or Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS

Read the detailed description

Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.

Being tested
Azacitidine, all trans retinoic acid
Keywords
acute myeloid leukemia, myelodysplastic syndromes, all-trans retinoic acid, azacitidine
Medical subject headings
Frailty, Hematologic Neoplasms, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

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

  • AzacitidineDrug

    Also called AZA

    Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle 28 days

  • all trans retinoic acidDrug

    Also called ATRA

    ATRA 20mg tid by po on days 1-21 of every cycle 28 days

Study groups in NCT05175508
Study groupRoleWhat they receive
Azacytidine Combined With ARTAExperimentalAzacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days
Receives: Drug: Azacitidine; Drug: all trans retinoic acid
AzacytidineExperimentalAzacytidine 75mg/m2/d by IV on days 1-7 of every cycle
Receives: Drug: Azacitidine

What is being measured

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

  1. Overall Response Rate （ORR)

    Number of participants (responders) achieving ORR after the 6 cycle treatments，Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI).

    Measured: 6 months

  2. Overall survival (OS)

    time from randomization to death from any cause, or last known date to be alive.

    Measured: 24months

  3. Progression-free survival (PFS)

    Progression-free survival (PFS) will be measured from time of enrolling in the clinical trial to the date on which disease progresses or the date on which the patient dies, whichever comes first.

    Measured: 24 months

Secondary outcomes (2)

  1. Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline

    TI is when the participants who were transfusion dependent on RBC and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, the initiation of post-treatment therapy, or death, whichever is earliest.

    Measured: 6 months

  2. Incidence of systemic infections

    Incidence of systemic infections

    Measured: 6 months

Timeline

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

  1. First posted3 Jan 2022
  2. Study start1 May 2021
  3. Primary completion1 May 2022 (estimated)
  4. Study completion1 May 2023 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05175508
Sponsor's protocol ID
SOOCHOW-HY-2021-03
Status last verified
Apr 2021
First submitted
1 Nov 2021
Last updated
3 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chinese Society of Hematology, Chinese Medical Association. [Chinese guidelines for diagnosis and treatment of myelodysplastic syndromes (2019)]. Zhonghua Xue Ye Xue Za Zhi. 2019 Feb 14;40(2):89-97. doi: 10.3760/cma.j.issn.0253-2727.2019.02.001. No abstract available. Chinese.

    PubMed 30831622

  • Leukemia & Lymphoma Group, Chinese Society of Hematology, Chinese Medical Association. [Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2017)]. Zhonghua Xue Ye Xue Za Zhi. 2017 Mar 14;38(3):177-182. doi: 10.3760/cma.j.issn.0253-2727.2017.03.001. No abstract available. Chinese.

    PubMed 28395438

  • Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.

    PubMed 25987659

  • Delia M, Carluccio P, Buquicchio C, Vergine C, Greco G, Amurri B, Melpignano A, Melillo L, Cascavilla N, Guarini A, Capalbo S, Tarantini G, Mazza P, Pavone V, Di Renzo N, Specchia G. Azacitidine in the treatment of older patients affected by acute myeloid leukemia: A report by the Rete Ematologica Pugliese (REP). Leuk Res. 2015 Aug 20:S0145-2126(15)30358-1. doi: 10.1016/j.leukres.2015.08.005. Online ahead of print.

    PubMed 26364798

  • Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.

    PubMed 19230772

  • Pappa V, Anagnostopoulos A, Bouronikou E, Briasoulis E, Kotsianidis I, Pagoni M, Zikos P, Tsionos K, Viniou N, Meletis J, Papadaki H, Kioumi A, Galanopoulos A, Vervessou EC, Poulakidas E, Karmas P, Karvounis K, Symeonidis A. A retrospective study of azacitidine treatment in patients with intermediate-2 or high risk myelodysplastic syndromes in a real-world clinical setting in Greece. Int J Hematol. 2017 Feb;105(2):184-195. doi: 10.1007/s12185-016-2115-y. Epub 2016 Nov 4.

    PubMed 27815858

  • Xiang L, Zhou J, Gu W, Wang R, Wei J, Qiu G, Cen J, Xie X, Chen Z. Changes in expression of WT1 during induced differentiation of the acute myeloid leukemia cell lines by treatment with 5-aza-2'-deoxycytidine and all-trans retinoic acid. Oncol Lett. 2016 Feb;11(2):1521-1526. doi: 10.3892/ol.2015.4052. Epub 2015 Dec 23.

    PubMed 26893773

  • Xiang L, Wang R, Wei J, Qiu G, Cen J, Hu S, Xie X, Chen Z, Gu W. Retinoic acid receptor-beta gene reexpression and biological activity in SHI-1 cells after combined treatment with 5-aza-2'-deoxycytidine and all-trans retinoic acid. Acta Haematol. 2015;133(3):279-86. doi: 10.1159/000367586. Epub 2014 Nov 20.

    PubMed 25413479

  • Xiang L, Dong W, Wang R, Wei J, Qiu G, Cen J, Chen Z, Zheng X, Hu S, Xie X, Cao X, Gu W. All-trans retinoic acid enhances the effect of 5-aza-2'-deoxycytidine on p16INK4a demethylation, and the two drugs synergistically activate retinoic acid receptor beta gene expression in the human erythroleukemia K562 cell line. Oncol Lett. 2014 Jul;8(1):117-122. doi: 10.3892/ol.2014.2133. Epub 2014 May 12.

    PubMed 24959230

  • Wu W, Lin Y, Xiang L, Dong W, Hua X, Ling Y, Li H, Yan F, Xie X, Gu W. Low-dose decitabine plus all-trans retinoic acid in patients with myeloid neoplasms ineligible for intensive chemotherapy. Ann Hematol. 2016 Jun;95(7):1051-7. doi: 10.1007/s00277-016-2681-3. Epub 2016 Apr 26.

    PubMed 27116384

  • Lubbert M, Grishina O, Schmoor C, Schlenk RF, Jost E, Crysandt M, Heuser M, Thol F, Salih HR, Schittenhelm MM, Germing U, Kuendgen A, Gotze KS, Lindemann HW, Muller-Tidow C, Heil G, Scholl S, Bug G, Schwaenen C, Giagounidis A, Neubauer A, Krauter J, Brugger W, De Wit M, Wasch R, Becker H, May AM, Duyster J, Dohner K, Ganser A, Hackanson B, Dohner H; DECIDER Study Team. Valproate and Retinoic Acid in Combination With Decitabine in Elderly Nonfit Patients With Acute Myeloid Leukemia: Results of a Multicenter, Randomized, 2 x 2, Phase II Trial. J Clin Oncol. 2020 Jan 20;38(3):257-270. doi: 10.1200/JCO.19.01053. Epub 2019 Dec 3.

    PubMed 31794324

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Azacitidine and all trans retinoic acid in people with AML and MDS, run by The First Affiliated Hospital of Soochow University at 1 site in China.

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 6 inclusion and 3 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 3 Jan 2022. 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 China. 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 combined 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.

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 Han Yue, Ph.D ((0086)51267781856, hanyue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate （ORR) (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05175508, which also lists 11 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 3 Jan 2022.

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