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Leukemia, Myeloid, AcutePhase 2NCT05583175

Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies

A Phase 2 study testing Venetoclax plus RIC in people with Leukemia, Myeloid, Acute and MDS, run by Xianmin Song, MD 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a single center, single arm, prospective, phase II clinical study to evaluate the efficacy and safety of Venatoclax combined with reduced intensity conditioning regimen allo-HSCT in the treatment of high-risk myeloid malignancies in the elderly patients. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Venetoclax plus RIC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Nov 2022to 1 Nov 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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 55 years old;
  • High risk myeloid malignancies： 1）No hematological remission(NR) after induction/re-induction treatment for AML; 2）Morphological remission but with persistent positive minimal resident disease(MRD) (Flow cytometry>0.01% and/or fusion gene positive and/or digital polymerase chain reaction(PCR) positive）; 3）High risk acute myeloid leukemia(AML) according to 2022 European Leukemia Net(ELN) risk stratification； 4）High risk myelodysplastic syndrome(MDS): IPSS-R score ≥ middle risk-2; therapy-related MDS; MDS with mutation of ASXL1, EZH2, RUNX1, SRSF2, U2AF1, STAG2, NRAS, ZRSR2, or TP53； 5）High risk chronic myelomonocytic leukemia(CMML), MDS/MPN.
  • Patients must have appropriate donor:
  • 1）Related donor must be HLA-A, - B, - C, - DQB1 and - DRB1 matched at least 5/10; 2）Unrelated donor must be HLA-A, - B, - C, - DQB1 and - DRB1 matched at least 8/10; 4. Hematopoietic cell transplantation-comorbidity Index(HCT-CI) score ≤ 4。 5. Eastern Cooperative Oncology Group(ECOG) score 0-2。 6. Liver, kidney and cardiopulmonary functions meet the following requirements:
  • Creatinine≤1.5×ULN;
  • Left ventricular ejection fraction >50%;
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  • Baseline oxygen saturation>92%;
  • Total bilirubin≤1.5×ULN；ALT and AST≤2.0×ULN；
  • DLCO≥ 40% and FEV1 ≥ 50%。 7. Able to understand and sign the Informed Consent Document.

Who cannot join

  • Patients with Venetoclax ineffectiveness;
  • Malignant tumors other than acute myeloid leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection；
  • ECOG socre>2;
  • HCT-CI score> 4。
  • Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 3 months prior to screening), myocardial infarction (within 3 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease; patients with pulmonary hypertension
  • Uncontrolled infection during screening period; Hemodynamic instability associated with infection,a new infection or aggravation of the original infection;new lesions on imaging;fever of unknown cause;
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  • Patients with symptoms of central nervous system;greater than grade 2 requiring treatment,paralysis,aphasia,acute cerebral infarction,severe traumatic brain injury,schizophrenia;
  • HIV infection;
  • Patients with active hepatitis B virus (HBV) and active hepatitis C virus (HCV) need antiviral treatment; Patients at risk of HBV activation refer to patients with positive HBsAg or HBeAb but not receiving anti-HBV treatment;
  • History of autoimmune disease；
  • Pregnant or lactating women；
  • Fertile men and women who are unwilling to use contraceptive technology during the treatment period and within 12 months after treatment.

Trial locations and contacts

1 site in 1 country.

Jie Gao contact

+86177882248225

siberia77@qq.com

Xianmin Song contact

+862163240090

shongxm@139.com

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Xianmin Song, M.D., 86-21-63240090 ext. 3172, shongxm@sjtu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Study of Venetoclax and Reduced-intensity Conditioning Regimen(RIC) for Allogeneic Stem Cell Transplantation(Allo-HSCT) in Elderly Patients With High-risk Myeloid Malignancies

This study is a single center, single arm, prospective, phase II clinical study to evaluate the efficacy and safety of Venatoclax combined with reduced intensity conditioning regimen allo-HSCT in the treatment of high-risk myeloid malignancies in the elderly patients.

Read the detailed description

Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation. The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or untreated MDS), 400mg/d, - 8d~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d~-2d (5d), Cytarabine: 1g/m2/d, - 6d~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d~-5d (2d), total body irradiation(TBI): 3 Gray, - 1d.

Primary end point: 1 year and 2 year progression free survival (PFS) after transplantation. Secondary end point: incidence of acute GVHD within 180 days after transplantation; cumulative rate of relapse, overall survival(OS), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), non-relapse mortality(NRM), and incidence of chronic GVHD at 1 and 2 years after transplantation; The reactivation rate of cytomegalovirus(CMV) and Epstein-Barr virus (EBV) within 1 year after transplantation.

Being tested
Venetoclax plus RIC
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.

  • Venetoclax plus RICDrug

    Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation. The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or untreated MDS), 400mg/d, - 8d~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d~-2d (5d), Cytarabine: 1g/m2/d, - 6d~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d~-5d (2d), TBI: 3 Gray, - 1d.

Study groups in NCT05583175
Study groupRoleWhat they receive
Venetoclax plus RICExperimentalAdministration with oral Venetoclax plus RIC regimen for allo-HSCT in the elderly patients with myeloid malignancies.
Receives: Drug: Venetoclax plus RIC

What is being measured

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

  1. PFS

    Progression free survival for all patients enrolled

    Measured: 1- year PFS

  2. PFS

    Progression free survival for all patients enrolled

    Measured: 2- year PFS

Secondary outcomes (10)

  1. OS

    Overall survival for all patients enrolled

    Measured: 1- year OS

  2. OS

    Overall survival for all patients enrolled

    Measured: 2- year OS

  3. aGVHD rate

    The incidence rate of acute GVHD after transplantation

    Measured: 180 days after transplantation

  4. cGVHD rate

    The incidence rate of chronic GVHD after transplantation

    Measured: 1 year after transplantation

  5. cGVHD rate

    The incidence rate of chronic GVHD after transplantation

    Measured: 2 years after transplantation

  6. Relapse rate

    Cumulative relapse rate after transplantation

    Measured: 1 year after transplantation

  7. NRM

    Non relapse mortality after transplantation

    Measured: 2 years after transplantation

  8. GVHD-free relapse-free survival(GRFS)

    Time from transplantation to the diagnosis of chronic GVHD or relapse

    Measured: 2 years after transplantation

  9. Reactivation rate of EBV and CMV

    Reactivation rate of Epstein-Barr virus and cytomegalovirus after transplantation

    Measured: 1 year after transplantation

  10. Reactivation rate of EBV and CMV

    Reactivation rate of Epstein-Barr virus and cytomegalovirus after transplantation

    Measured: 2 years after transplantation

Timeline

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

  1. First posted17 Oct 2022
  2. Study start1 Nov 2022
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Nov 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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05583175
Sponsor's protocol ID
SHSYXY-202202-VEN-RIC
Status last verified
Nov 2023
First submitted
9 Oct 2022
Last updated
28 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia JS, Kim HT, Murdock HM, Cutler CS, Brock J, Gooptu M, Ho VT, Koreth J, Nikiforow S, Romee R, Shapiro R, Loschi F, Ryan J, Fell G, Karp HQ, Lucas F, Kim AS, Potter D, Mashaka T, Stone RM, DeAngelo DJ, Letai A, Lindsley RC, Soiffer RJ, Antin JH. Adding venetoclax to fludarabine/busulfan RIC transplant for high-risk MDS and AML is feasible, safe, and active. Blood Adv. 2021 Dec 28;5(24):5536-5545. doi: 10.1182/bloodadvances.2021005566.

    PubMed 34614506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax plus RIC in people with Leukemia, Myeloid, Acute and MDS, run by Xianmin Song, MD 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 9 inclusion and 12 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 28 Nov 2023. 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 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 Jie Gao (+86177882248225, siberia77@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 1- year PFS). The study lists 2 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 NCT05583175, 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 28 Nov 2023.

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