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Acute Lymphoblastic LeukemiaPhase 1/2NCT06087419

A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Venetoclax in RR Ph-ALL and B-cell Lymphoma Patients

A Phase 1/2 study testing chidamide, Venetoclax Oral Tablet and Inotuzumab Ozogamicin in people with Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 multicenter, prospective, interventional clinical trial aimed at recruiting relapsed/refractory Ph-ALL patients at multiple stem cell transplantation centers, including the Stem Cell Transplantation Center of the Chinese Academy of Medical Sciences Hematology Hospital. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
chidamide, Venetoclax Oral Tablet and Inotuzumab Ozogamicin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
30 Oct 2023to 30 Dec 2025
Phase
Phase 1/2
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

  • Confirmed diagnosis of acute lymphoblastic leukemia/lymphoblastic lymphoma with negative Ph chromosome or BCR/ABL fusion gene, and surface expression of CD22 on leukemic cells. First relapse, multiple relapses, or failure to achieve hematological remission after at least 3 cycles of intensive chemotherapy.
  • Age greater than or equal to 18 years.
  • Must have adequate organ function: Renal function and liver function as follows: AST, ALT, and ALP levels less than 2 times the upper limit of normal, total bilirubin level less than 1.5 times the upper limit of normal; Creatinine clearance greater than 50 mL/min; Pancreatic function: Serum amylase not higher than 1.5 times the upper limit of normal, serum lipase not higher than 1.5 times the upper limit of normal; Normal cardiac function: Ejection fraction (EF) > 60%, pulmonary artery systolic pressure ≤ 50 mmHg.
  • HIV negative, HBV and HCV negative.
  • Eastern Cooperative Oncology Group performance status assessment (ECOG-PS) score of 0-2.
  • Informed consent must be signed before the start of the study. For participants aged 18 and above, the informed consent should be signed by the patient or their immediate family member. Considering the patient's condition, if it is not favorable for the patient to sign, the informed consent may be signed by a legal guardian or immediate family member of the patient.

Who cannot join

  • Lack of CD22 expression on the surface of leukemia cells.
  • Mixed lineage leukemia.
  • Patients with concomitant malignancies; patients assessed to have accompanying diseases that pose a severe risk to patient's life or would interfere with the completion of this study.
  • Patients with a severe (≥ Grade 3) allergy to the components and excipients of obinutuzumab, idarubicin, and venetoclax.
  • Clinically significant liver disease, such as a history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); severe/uncontrolled liver disease, such as cirrhosis, decompensated liver disease, acute or chronic hepatitis.
  • Active cardiac disease, defined as any of the following: history of any cardiac or vascular disease; uncontrolled or symptomatic history of angina pectoris; myocardial infarction within 6 months prior to study entry; history of clinically significant arrhythmia requiring medication or with severe clinical symptoms; uncontrolled or symptomatic congestive heart failure (> NYHA class 2); ejection fraction below the lower limit of normal range; pulmonary artery systolic pressure > 50 mmHg on echocardiography or clinical symptoms related to pulmonary arterial hypertension.
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  • Known positive serological reaction for HIV or active hepatitis C virus.
  • Presence of psychiatric disorders or other conditions that would hinder compliance with study treatment and monitoring requirements.
  • Inability or unwillingness to sign the informed consent form.
  • Pregnant or lactating females.
  • Patients deemed ineligible due to other specific circumstances as assessed by the investigator.

About this study

Official title: A Prospective, Single-arm Clinical Study of Bridging Allogeneic Stem Cell Transplantation After Treatment With Obinutuzumab in Combination With Chidamide and Venetoclax in Relapsed/Refractory Ph-ALL and B-cell Lymphoma Patients

This study is a multicenter, prospective, interventional clinical trial aimed at recruiting relapsed/refractory Ph-ALL patients at multiple stem cell transplantation centers, including the Stem Cell Transplantation Center of the Chinese Academy of Medical Sciences Hematology Hospital. The anticipated enrollment is 42 subjects. The enrolled patients are planned to receive a treatment regimen of chidamide in combination with venetoclax and obinutuzumab. Patients who achieve remission will undergo allogeneic stem cell transplantation, followed by continued oral maintenance therapy with chidamide for one year post-transplantation based on the disease condition.

Read the detailed description

Relapsed/refractory Ph-ALL patients who meet the inclusion criteria and provide informed consent will be enrolled in the study. They will receive combination chemotherapy with chidamide, venetoclax, and obinutuzumab. After one treatment cycle, if the patient achieves complete remission (CR) and minimal residual disease (MRD) negativity, they will proceed to the preparatory phase for allogeneic stem cell transplantation. In cases where MRD remains positive after one cycle of chemotherapy, the same regimen will be repeated for an additional cycle, followed by re-evaluation. Once MRD negativity is achieved, the patient will enter the preparatory phase for allogeneic stem cell transplantation. After successful hematopoietic recovery post-transplantation (neutrophil count >0.5×10^9/L, platelet count >50×10^9/L), chidamide 10mg qd will be added for maintenance therapy, which will be continued for one year post-transplantation.

Being tested
chidamide, Venetoclax Oral Tablet, Inotuzumab Ozogamicin
Keywords
acute lymphoblastic leukemia, chidamide
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • chidamideDrug

    30mg twice weekly (BIW) for induction phase (cycle1-2,28 days per cycle)

  • Venetoclax Oral TabletDrug

    400mg daily d1-14 induction phase (cycle1-2, 28 days per cycle)

  • Inotuzumab OzogamicinDrug

    0.6 mg/m2 on day 1 of cycle 1-2(28 days per cycle)

Study groups in NCT06087419
Study groupRoleWhat they receive
combination drug groupExperimentalNot described
Receives: Drug: chidamide; Drug: Venetoclax Oral Tablet; Drug: Inotuzumab Ozogamicin

What is being measured

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

  1. Overall survival

    One-year overall survival rate (OS) after allogeneic stem cell transplantation.

    Measured: 24months

Secondary outcomes (6)

  1. Complete remission

    Complete remission (CR) rate following treatment with obinutuzumab in combination with chidamide and venetoclax.

    Measured: 24months

  2. relapse-free survival

    One-year relapse-free survival (RFS) after allogeneic stem cell transplantation.

    Measured: 24months

  3. Incidence of graft-versus-host disease

    Incidence of graft-versus-host disease (GVHD) following allogeneic stem cell transplantation.

    Measured: 24months

  4. Engraftment rate

    Engraftment rate post-transplantation.

    Measured: 24months

  5. Minimal residual disease rate

    Minimal residual disease (MRD) clearance rate following chemotherapy.

    Measured: 24months

  6. Bridging transplant rate.

    Bridging transplant rate.

    Measured: 24months

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 2023
  2. Study start30 Oct 2023 (estimated)
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2025 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087419
Sponsor's protocol ID
CD22-HDACi-VEN-2023
Status last verified
Nov 2023
First submitted
11 Oct 2023
Last updated
2 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing chidamide, Venetoclax Oral Tablet and Inotuzumab Ozogamicin in people with Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, 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 11 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 2 Nov 2023. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 24months). 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 NCT06087419.

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 2 Nov 2023.

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