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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06087419
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • chidamide — DRUG
    30mg twice weekly (BIW) for induction phase (cycle1-2,28 days per cycle)
  • Venetoclax Oral Tablet — DRUG
    400mg daily d1-14 induction phase (cycle1-2, 28 days per cycle)
  • Inotuzumab Ozogamicin — DRUG
    0.6 mg/m2 on day 1 of cycle 1-2(28 days per cycle)

Study Details

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.

Key Dates

Start date
Oct 30, 2023
Status verified
Nov 2023
Primary completion
Dec 30, 2024
Completion
Dec 30, 2025

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination drug group

Primary Outcome Measure

Overall survival [ Time Frame: 24months ]

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