2025-522019-40-00招募中2 期
A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 25
研究概览
简要总结
The primary objective for Part 1 dose escalation is to determine the RP2D and the primary endpoints will be the incidence of DLTs and incidence of severity of AEs and laboratory safety findings. The primary objective for Part 2 dose expansion will be to assess complete remission rates at the end of cycle 1 and the primary endpoint will be proportion of CR evaluable Ph+ participants achieving CR at the end of cycle 1
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ≥1 year to ≤30 years of age at screening
- •Participants with documented history of either Ph+ ALL or ABL-class Ph-like ALL with ABL1 or ABL2 rearrangements. Genetic testing will be performed locally and eligible alterations confirmed by treating investigators; central confirmation will not be performed as part of the study. (Of note, participants with T315I mutations are eligible for inclusion in Part 1 and Part 2).
- •Active B-Cell ALL at screening defined by MFC or IG/TCR PCR of ALL blasts >0.01% in participants with either: a. Primary refractory disease (>0.01% ALL blasts present at the end of consolidation) OR b. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG/TCR PCR>0.01%) after at least one line of therapy
- •Participants with CNS1, CNS2, CNS3a or CNS3b at screening.
- •Documented history of CD19 expressing B-cell ALL (in peripheral blood or bone marrow by flow cytometry) a. For participants who received anti-CD19 targeted therapy (e.g CD19 CAR T cells or blinatumomab), CD19 expressing B-cell ALL must be documented after anti-CD19 therapy completion prior to cycle 1 day 1.
排除标准
- •Participants with >3 relapses of ALL at screening.
- •Extramedullary disease (non-CNS and/ or isolated CNS disease) at screening
- •Participants with CNS3c at screening (Clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome).
- •History of hematopoietic stem cell transplant within the prior 12 weeks
- •Presence of active acute or chronic graft-versus-host disease (GVHD). Hematopoietic stem cell transplant recipients receiving any agent to treat or prevent GVHD within 4 weeks are not eligible for this trial.
研究组 & 干预措施
DBL methotrexate injection
Auxiliary
干预措施: DBL methotrexate injection (Drug)
PREDNISOLONE ACETATE PH. EUR.
Auxiliary
干预措施: PREDNISOLONE ACETATE PH. EUR. (Drug)
VINCRISTINE SULFATE
Test
干预措施: VINCRISTINE SULFATE (Drug)
ASCIMINIB HYDROCHLORIDE, Asciminib
Test
干预措施: ASCIMINIB HYDROCHLORIDE (Drug)
HYDROCORTISONE
Auxiliary
干预措施: HYDROCORTISONE (Drug)
BLINATUMOMAB
Test
干预措施: BLINATUMOMAB (Drug)
METHOTREXATE
Auxiliary
干预措施: METHOTREXATE (Drug)
DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE
Test
干预措施: DEXAMETHASONE (Drug)
DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE
Test
干预措施: DEXAMETHASONE SODIUM PHOSPHATE (Drug)
ASCIMINIB HYDROCHLORIDE, Asciminib
Test
干预措施: Asciminib (Drug)
CYTARABINE
Auxiliary
干预措施: CYTARABINE (Drug)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (25)
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