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Trial Title:
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
NCT ID:
NCT06087419
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Venetoclax
Inotuzumab Ozogamicin
Conditions: Keywords:
acute lymphoblastic leukemia
chidamide
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
chidamide
Description:
30mg twice weekly (BIW) for induction phase (cycle1-2,28 days per cycle)
Arm group label:
combination drug group
Intervention type:
Drug
Intervention name:
Venetoclax Oral Tablet
Description:
400mg daily d1-14 induction phase (cycle1-2, 28 days per cycle)
Arm group label:
combination drug group
Intervention type:
Drug
Intervention name:
Inotuzumab Ozogamicin
Description:
0.6 mg/m2 on day 1 of cycle 1-2(28 days per cycle)
Arm group label:
combination drug group
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Age greater than or equal to 18 years.
3. 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.
4. HIV negative, HBV and HCV negative.
5. Eastern Cooperative Oncology Group performance status assessment (ECOG-PS) score of
0-2.
6. 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.
Exclusion Criteria:
1. Lack of CD22 expression on the surface of leukemia cells.
2. Mixed lineage leukemia.
3. 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.
4. Patients with a severe (≥ Grade 3) allergy to the components and excipients of
obinutuzumab, idarubicin, and venetoclax.
5. 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.
6. 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.
7. Known positive serological reaction for HIV or active hepatitis C virus.
8. Presence of psychiatric disorders or other conditions that would hinder compliance
with study treatment and monitoring requirements.
9. Inability or unwillingness to sign the informed consent form.
10. Pregnant or lactating females.
11. Patients deemed ineligible due to other specific circumstances as assessed by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 30, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06087419
