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NLA101 in Adults Receiving High Dose Chemotherapy for AML

NCT03301597 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2021-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

BIOLOGICAL

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.

DRUG

Standard of Care (SOC) chemotherapy

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.

Sponsors & Collaborators

  • Nohla Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin S Tallman, MD · Memorial Sloan Kettering Cancer Center

  • Naval G Daver, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2019-03-18
Completion
2019-03-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301597 on ClinicalTrials.gov