Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Bacterial Infections

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Communicable Diseases

Mycoses

Neutropenia

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Granulocytopenia

Acute Graft Versus Host Disease

The Control Arm will receive standard of care (SOC) chemotherapy without the infusion of NLA101. SOC chemotherapy will be determined by local PI and must be a standard regimen for untreated de novo or secondary AML that will result in moderate to severe myelosuppression and will be given with curative intent.

The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.

The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.

The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.

NLA101 is a universal donor "off-the-shelf" ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use.

NLA101

The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.

Standard of Care (SOC) chemotherapy

Martin S Tallman, MD

Naval G Daver, MD

Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.

Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced neutropenia (CIN) in adult subjects with AML.

Eligible subjects with untreated de novo or secondary AML and per local institutional standards planned to receive at least two cycles of chemotherapy with curative intent will be enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of Care \[SOC\] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC chemotherapy).

Subjects randomized to an Investigational Arm will be eligible to receive a single fixed assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle). Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy.

All subjects will be followed for 84 days following randomization, or 30 days post final infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control Arm, whichever is longer.

Subjects will be randomized to 1 of 3 Investigational Arms or a Control Arm in a 1:1:1:1 ratio.

NLA101 in Adults Receiving High Dose Chemotherapy for AML

A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia

Nohla Therapeutics, Inc.

Immune System Diseases

Recurrence

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Agammaglobulinemia

Disease Attributes

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Bacterial Infections and Mycoses

Blood Protein Disorders

Syndrome

Immunologic Deficiency Syndromes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Immunologic Factors

Participants will receive a loading dose of 150 milligrams per kilograms per day (mg/kg/day) (Week 1, Days 1 to 5) subcutaneously (SC) for 5 consecutive daily doses followed by weekly infusions of 150 mg/kg starting Week 2 (Day 8) through Week 53 (end of Treatment Phase).

The SMT will include the antileukemic treatments and the other supportive treatments that the participants will need during their participation.

Participants will receive sterile 0.9 percent Sodium Chloride Injection, United States Pharmacopeia (USP) or equivalent starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by weekly infusions starting at Week 2 (Day 8) through Week 53.

The SMT will include the antileukemic treatments and the other supportive treatments that the participants will need during their participation.

Xembify

Placebo

Terra Stockwell

Marina Acosta Enslen

The primary purpose of the study is to evaluate whether weekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in participants with hypogammaglobulinemia (HGG) associated with B-cell chronic lymphocytic leukemia (CLL) in comparison to the Placebo plus SMT group.

A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia

A Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia

Grifols Therapeutics LLC

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Virus Diseases

Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Antineoplastic Agents

Inotuzumab Ozogamicin

Paola Fazi

Enrico Crea

Luana Fianchi

Livio Pagano

The goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The main question it aims to answer is:

• incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment

The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin (INO) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).

Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO

Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)

To estimate the rate of clinically or microbiologically documented infectious complications (bacterial, fungal, viral) in acute lymphoblastic leukemia patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered).

Gruppo Italiano Malattie EMatologiche dell'Adulto

Respiratory Tract (Lung and Bronchial) Diseases

Pneumonia

Escherichia coli Infections

Klebsiella Infections

Gram-Positive Bacterial Infections

Enterobacteriaceae Infections

Gram-Negative Bacterial Infections

Klebsiella Infection

Anti-Infective Agents

Tazobactam

Piperacillin

Piperacillin, Tazobactam Drug Combination

Anti-Bacterial Agents

beta-Lactamase Inhibitors

Enzyme Inhibitors

piperacillin-tazobactam

Medical Monitor

To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units

Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units

Effects of Piperacillin-Tazobactam Use on the Prevalence Rate of Extended-Spectrum Beta-Lactamase (ESBL) Producing Escherichia Coli and Klebsiella Pneumoniae in Hematology and Oncology Units.

Wyeth is now a wholly owned subsidiary of Pfizer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NLA101 in Adults Receiving High Dose Chemotherapy for AML	NCT03301597	Leukemia, Myelo...	NLA101 Standard of Car...	18 Years -	Nohla Therapeutics, Inc.
A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia	NCT05645107	Hypogammaglobul... Bacterial Infec... B-cell Chronic ...	Xembify Placebo	18 Years -	Grifols Therapeutics LLC
Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO	NCT06025682	Acute Lymphobla... Infections Bacterial Infec... Viral Infection Fungal Infectio... Acute Lymphobla... Acute Lymphobla...		18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units	NCT00167999	Gram-Positive B... Escherichia Col... Klebsiella Infe...	piperacillin-ta...	15 Years -	Wyeth is now a wholly owned subsidiary of Pfizer

Spots Global Cancer Trial Database for bacterial infections