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Relapsed Acute Myeloid LeukemiaPhase 2NCT05362942

Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia

A Phase 2 study testing Venetoclax, Decitabine, Azacytidine, Cytarabine in people with Relapsed Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Beijing 302 Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Venetoclax, Decitabine, Azacytidine, Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
1 May 2022to 30 Apr 2024
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

  • Aged ≥18 years old, voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
  • The toxic and side effects caused by the last treatment should be recovered.
  • Eastern Cooperative Oncology Group score of 0 to 3 points.
  • The organ function is intact.
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (Upper Limit of Normal).
  • Creatinine≤1.5×ULN.
Show all 10Show fewer
  • Bilirubin≤1.5×ULN.
  • Karnofsky≥70.
  • The expected survival period is at least 12 weeks.
  • Non-pregnant, non-breastfeeding women.

Who cannot join

  • Suffering from other untreated or unrelieved malignant tumors within 2 years.
  • Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
  • Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association [NYHA] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
  • Patients who are unwilling or unable to comply with the protocol.
  • Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
  • Women who are pregnant or breastfeeding.

Trial locations and contacts

No sites are listed yet.

Xiao-ning Gao contact

+861066947169

gaoxn@263.net

Lei Xu contact

+861066947174

xulei800@hotmail.com

About this study

Official title: A Study of Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy in Patients With Acute Myeloid Leukemia Who Had Relapsed/Refractory Disease or Positive Minimal Residual Disease

Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. In this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.

Read the detailed description

Although the promising activity of venetoclax-based therapy is well demonstrated in the treatment of previously untreated elderly or unfit patients with acute myeloid leukemia, there are few data on the efficacy of venetoclax-based salvage therapy in relapsed/refractory patients, which can be difficult to treat. To date, data on venetoclax as monotherapy or in combination with hypomethylation agent or low-dose cytarabine as a salvage regimen in relapsed/refractory AML are scarce and heterogenous. In this study, the investigators aimed to assess safety and efficiency of a new triple-drug combination regimen, venetoclax + hypomethylation agent + low-dose cytarabine, in patients with relapsed/refractory acute myeloid leukemia or persistent positive minimal residual disease in the salvage setting.

Being tested
Venetoclax, Decitabine, Azacytidine, Cytarabine
Keywords
Venetoclax, Hypomethylation agent, Cytarabine
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasm, Residual

What participants receive

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

  • Venetoclax, Decitabine, Azacytidine, CytarabineDrug

    Also called Venetoclax (ABT-199, GDC-0199), Decitabine (Dacogen, 5-aza-2-deoxycytidine), Azacitidine (5-Azacytidine, Ladakamycin), Cytarabine (Cytarabine hydrochloride)

    Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days (n=3) or azacytidine (n=8) was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. Cytarabine was given at a dose of 10 mg/m2 twice daily for 7 days.

Study groups in NCT05362942
Study groupRoleWhat they receive
venetoclax + Hypomethylation agent + low-dose cytarabine treatment groupExperimentalpatients treated with venetoclax combined with decitabine/azacytidine and low-dose cytarabine
Receives: Drug: Venetoclax, Decitabine, Azacytidine, Cytarabine

What is being measured

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

  1. Complete remission rate

    percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)

    Measured: At the end of Cycle 2 (each cycle is 28 days)

  2. Complete minimal residual disease (MRD) Response Rate

    Percentage of subjects with MRD negative or MRD < 0.01%

    Measured: At the end of Cycle 2 (each cycle is 28 days)

  3. MRD Response Rate

    Percentage of subjects with MRD < 0.1% detectable by multicolor flow cytometry

    Measured: At the end of Cycle 2 (each cycle is 28 days)

Secondary outcomes (4)

  1. Relapse-Free Survival

    Time interval from leukemia free state to the first recurrence or death

    Measured: 24 months

  2. Overall Survival

    Time interval from start of treatment until death or last follow-up

    Measured: 24 months

  3. Duration of response

    Time interval from morphologic/MRD response to loss of response or death

    Measured: 24 months

  4. Adverse events

    Number of subjects with adverse events

    Measured: start of treatment to 2 weeks after end of treatment

Timeline

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

  1. First posted5 May 2022
  2. Study start1 May 2022 (estimated)
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Apr 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05362942
Sponsor's protocol ID
VAA-RR&MRD2022V1.0
Status last verified
May 2022
First submitted
20 Apr 2022
Last updated
5 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burnett AK. Acute myeloid leukemia: treatment of adults under 60 years. Rev Clin Exp Hematol. 2002 Mar;6(1):26-45; discussion 86-7. doi: 10.1046/j.1468-0734.2002.00058.x.

    PubMed 12060482

  • Breems DA, Van Putten WL, Huijgens PC, Ossenkoppele GJ, Verhoef GE, Verdonck LF, Vellenga E, De Greef GE, Jacky E, Van der Lelie J, Boogaerts MA, Lowenberg B. Prognostic index for adult patients with acute myeloid leukemia in first relapse. J Clin Oncol. 2005 Mar 20;23(9):1969-78. doi: 10.1200/JCO.2005.06.027. Epub 2005 Jan 4.

    PubMed 15632409

  • Burnett A, Wetzler M, Lowenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011 Feb 10;29(5):487-94. doi: 10.1200/JCO.2010.30.1820. Epub 2011 Jan 10.

    PubMed 21220605

  • Roboz GJ, Rosenblat T, Arellano M, Gobbi M, Altman JK, Montesinos P, O'Connell C, Solomon SR, Pigneux A, Vey N, Hills R, Jacobsen TF, Gianella-Borradori A, Foss O, Vetrhusand S, Giles FJ. International randomized phase III study of elacytarabine versus investigator choice in patients with relapsed/refractory acute myeloid leukemia. J Clin Oncol. 2014 Jun 20;32(18):1919-26. doi: 10.1200/JCO.2013.52.8562. Epub 2014 May 19.

    PubMed 24841975

  • DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, Frankfurt O, Konopleva M, Wei AH, Kantarjian HM, Xu T, Hong WJ, Chyla B, Potluri J, Pollyea DA, Letai A. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25.

    PubMed 30361262

  • Wei AH, Strickland SA Jr, Hou JZ, Fiedler W, Lin TL, Walter RB, Enjeti A, Tiong IS, Savona M, Lee S, Chyla B, Popovic R, Salem AH, Agarwal S, Xu T, Fakouhi KM, Humerickhouse R, Hong WJ, Hayslip J, Roboz GJ. Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J Clin Oncol. 2019 May 20;37(15):1277-1284. doi: 10.1200/JCO.18.01600. Epub 2019 Mar 20.

    PubMed 30892988

  • DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

    PubMed 32786187

  • Bewersdorf JP, Giri S, Wang R, Williams RT, Tallman MS, Zeidan AM, Stahl M. Venetoclax as monotherapy and in combination with hypomethylating agents or low dose cytarabine in relapsed and treatment refractory acute myeloid leukemia: a systematic review and meta-analysis. Haematologica. 2020 Nov 1;105(11):2659-2663. doi: 10.3324/haematol.2019.242826. No abstract available.

    PubMed 33131256

  • Qin T, Youssef EM, Jelinek J, Chen R, Yang AS, Garcia-Manero G, Issa JP. Effect of cytarabine and decitabine in combination in human leukemic cell lines. Clin Cancer Res. 2007 Jul 15;13(14):4225-32. doi: 10.1158/1078-0432.CCR-06-2762.

    PubMed 17634552

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax, Decitabine, Azacytidine, Cytarabine in people with Relapsed Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Beijing 302 Hospital.

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 10 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 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Xiao-ning Gao (+861066947169, gaoxn@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate (time frame: At the end of Cycle 2 (each cycle is 28 days)). 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 NCT05362942, which also lists 9 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 5 May 2022.

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