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

NCT06087419 | Unknown Phase 1

• 1 other identifier: CD22-HDACi-VEN-2023
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemia; chidamide

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  24months

Secondary Outcomes (6)

• Complete remission

  24months

• relapse-free survival

  24months

• Incidence of graft-versus-host disease

  24months

• Engraftment rate

  24months

• Minimal residual disease rate

  24months

Study Arms (1)

combination drug group

EXPERIMENTAL

Drug: chidamide; Drug: Venetoclax Oral Tablet; Drug: Inotuzumab Ozogamicin

Interventions

chidamide DRUG

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

combination drug group

Venetoclax Oral Tablet DRUG

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

combination drug group

Inotuzumab Ozogamicin DRUG

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

combination drug group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; venetoclax; Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-11