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Leukemia, Myeloid, Acute

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GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older

GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older

GMI-1271

Daniel DeAngelo, MD, PhD

This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.

Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML

A Phase I/II, Open-label Multicenter Trial to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia

Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment

Time from date of first dose to first documentation of response

Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first

Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first

The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug

GlycoMimetics Incorporated

Symptoms and General Pathology

Immune System Diseases

Neoplasm Metastasis

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Methotrexate

Rituximab

Antineoplastic Agents, Immunological

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Escalating doses of oral ATG-010 weekly in a 3+3 design. ATG-010 dose level (DL) 1, 2 and 3 are 60, 80 and 100mg respectively respectively on day 1,8,15,22 for 28-days cycle.and the phase 2 expansion at the recommended dose level based on phase 1b trial. And，

Methotrexate 3.5 g/m2, d1 and Rituximab 375 mg/m2, d0, 28-days cycle.The total 6 cycles, 28 days per cycle.

Selinexor dose escalation: 60,80,100mg respectively on day 1,8,15,22 for 28 days cycles, and dose expansion at the RP2D of Selinexor.

PR patients after induction treatment will continue ATG-010 maintenance up to 1 year or until disease progression, intolerable toxicity, death.

Selinexor

Rituximab 375 mg/m2 intravenous infusion d1, every 28 days for 6 cycles during combination induction treatment.

high-dose Methotrexate 3.5 g/m2 intravenous infusion d1, every 28 days for 6 cycles during combination induction treatment.

Tong Chen, Ph.D

Yuan Yan, Ph.D

Jian Ge, Ph.D

Wenbin Li, Ph.D

Zhiyong Zeng, Ph.D

Mingzhi Zhang, PhD

Tong Chen

Yan Yuan

This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.

In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen （Methotrexate 3.5 g/m2, d1; Rituximab 375 mg/m2, d0）and escalating doses of oral ATG-010 weekly in a 3+3 design. ATG-010 dose level (DL) 1, 2 and 3 are 60, 80 and 100mg respectively respectively on day 1,8,15,22 for 28-days cycle.

The phase 2 expansion at the recommended dose level based on phase 1b trial. The total 6 cycles, 28 days per cycle . And, Subjects participating in the study will undergo a screening period（up to 21days）, a treatment period, and a follow-up period. The screening period is a maximum of 21 days before treatment period, And will be followed by 6 cycles of combination treatment（28 days per cycle）.

partial remission(PR) patients after induction treatment will continue ATG-010 maintenance up to 1 year or until disease progression, intolerable toxicity, death.

Selinexor in Combination With MTX+Ritu to Treat R/R CNSL

Selinexor in Combination With Methotrexate and Rituximab for Relapsed /Refractory Central Nervous System (CNS) Lymphoma

The types of gene mutations and frequency of tumor are measured by whole exon sequencing via NGS(next-generation sequencing).

The levels of cytokines will be analyzed by flow cytometry

The levels of ctDNA will be analyzed by next-generation sequencing.

The MTD will be determined by study definition as the highest dose level without significant safety and tolerability concern.

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy data collected during the dose escalation portion of the study

ORR is defined as the proportion of patients with a best response of Complete remission (CR) or Unconfirmed(CRu), or PR during induction therapy

Duration from the first observation of at least PR to time of progressive disease(PD), or deaths due to disease progression,whichever occurs first

Duration from start of study treatment to PD or death (regardless of cause), whichever comes first

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML	NCT02306291	Leukemia, Myelo...	GMI-1271 Mitoxantrone Etoposide Cytarabine Idarubicin	18 Years -	GlycoMimetics Incorporated
Selinexor in Combination With MTX+Ritu to Treat R/R CNSL	NCT05698147	Central Nervous...	Selinexor Rituximab Methotrexate	18 Years - 75 Years	Huashan Hospital

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