RECRUITING

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)

Conditions

Nontuberculous Mycobacterium Infection Cystic Fibrosis Gallium Nitrate IV Gallium Nontuberculous mycobacterium NTM Mycobacterium abscessus mycobacterium avium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD)

Official Title

A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)

Quick Facts

Study Start:2021-06-17

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04294043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent obtained from subject or subject's legal representative 2. Be willing and able to adhere to the study visit schedule and other protocol requirements 3. All sexes ≥ 18 years of age at Visit 1 4. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype. 5. Documentation of persistently positive NTM culture results that are positive for the same species or sub-species (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus). Persistently positive cultures are those which meet ONE of the following criteria, after first ignoring any negative culture results that occur within 7 days of a positive culture: 1. The two most recent NTM culture results from sputum or bronchoalveolar lavage (BAL) taken at least 28 days apart are positive. 2. At least one NTM culture result in the previous 4 months from sputum or BAL is positive. If there are four or more cultures in the last 12-months at least 3 out of the 4 most recent cultures must be positive for NTM. If there are three or fewer cultures in the past 12 months, then at least 2 of the 3 most recent cultures must be positive for NTM even if some of those cultures are more than 12 months ago. 6. Current NTM species or subspecies has never been treated or previous treatment was associated with clearance of NTM and completed \> 2 years prior to Day 1 7. forced expiratory volume at one second (FEV1) ≥ 25 % of predicted value at Screening 8. Able to expectorate sputum 9. Clinically stable with no significant changes in health status within 7 days prior to Day 1 10. Enrolled in the CFF Patient Registry (CFF PR) 11. Willing to discontinue chronic azithromycin use for the duration of the study	1. Any of the following abnormal lab values at screening: * Hemoglobin \<10g/dL * Platelets \<100,000/mm3 * Absolute neutrophil count \< 1500/mm3 * Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) ≥3 x upper limit of normal * Serum creatinine \> 2.0 mg/dl and ≥1.5 x upper limit of normal * Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal) 2. History of solid organ or hematological transplantation 3. Use of bisphosphonates within 7 days prior to Day 1 4. Known sensitivity to gallium 5. Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1 6. In the opinion of the Investigator, features of active NTM disease are present (e.g., clinical worsening is likely due to NTM disease despite definitive treatment of co-pathogens and/or acute exacerbations) 7. Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months 8. Current diagnosis of osteoporosis 9. For people of childbearing potential: * Positive pregnancy test at Visit 1 or * Lactating or * Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study 10. For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study 11. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives 12. New initiation of chronic therapy (e.g., cystic fibrosis transmembrane conductance regulator (CFTR) modulators, ibuprofen, azithromycin, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1) 13. Use of azithromycin within 14 days prior to the screening visit.

Inclusion Criteria

Exclusion Criteria

1. Written informed consent obtained from subject or subject's legal representative
2. Be willing and able to adhere to the study visit schedule and other protocol requirements
3. All sexes ≥ 18 years of age at Visit 1
4. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype.
5. Documentation of persistently positive NTM culture results that are positive for the same species or sub-species (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus). Persistently positive cultures are those which meet ONE of the following criteria, after first ignoring any negative culture results that occur within 7 days of a positive culture:
1. The two most recent NTM culture results from sputum or bronchoalveolar lavage (BAL) taken at least 28 days apart are positive.
2. At least one NTM culture result in the previous 4 months from sputum or BAL is positive. If there are four or more cultures in the last 12-months at least 3 out of the 4 most recent cultures must be positive for NTM. If there are three or fewer cultures in the past 12 months, then at least 2 of the 3 most recent cultures must be positive for NTM even if some of those cultures are more than 12 months ago.
6. Current NTM species or subspecies has never been treated or previous treatment was associated with clearance of NTM and completed \> 2 years prior to Day 1
7. forced expiratory volume at one second (FEV1) ≥ 25 % of predicted value at Screening
8. Able to expectorate sputum
9. Clinically stable with no significant changes in health status within 7 days prior to Day 1
10. Enrolled in the CFF Patient Registry (CFF PR)
11. Willing to discontinue chronic azithromycin use for the duration of the study

1. Any of the following abnormal lab values at screening:
* Hemoglobin \<10g/dL
* Platelets \<100,000/mm3
* Absolute neutrophil count \< 1500/mm3
* Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) ≥3 x upper limit of normal
* Serum creatinine \> 2.0 mg/dl and ≥1.5 x upper limit of normal
* Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)
2. History of solid organ or hematological transplantation
3. Use of bisphosphonates within 7 days prior to Day 1
4. Known sensitivity to gallium
5. Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1
6. In the opinion of the Investigator, features of active NTM disease are present (e.g., clinical worsening is likely due to NTM disease despite definitive treatment of co-pathogens and/or acute exacerbations)
7. Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months
8. Current diagnosis of osteoporosis
9. For people of childbearing potential:
* Positive pregnancy test at Visit 1 or
* Lactating or
* Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study
10. For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study
11. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
12. New initiation of chronic therapy (e.g., cystic fibrosis transmembrane conductance regulator (CFTR) modulators, ibuprofen, azithromycin, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)
13. Use of azithromycin within 14 days prior to the screening visit.

Contacts and Locations

Study Contact

Natallia Cameron

CONTACT

206-884-7550

Natallia.Cameron@seattlechildrens.org

Principal Investigator

Christopher H. Goss, MD, MSc

PRINCIPAL_INVESTIGATOR

University of Washington, Seattle Children's Hospital

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

National Jewish Health

Denver, Colorado, 80206

United States

Johns Hopkins University

Baltimore, Maryland, 21205

United States

The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, 55455

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

University of Texas Southwestern

Dallas, Texas, 75390

United States

University of Vermont Medical Center

Burlington, Vermont, 05401

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Chris Goss

Christopher H. Goss, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Washington, Seattle Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-17

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-06-17

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Cystic Fibrosis
Gallium Nitrate
IV Gallium
Nontuberculous mycobacterium
NTM
Mycobacterium abscessus
mycobacterium avium

Additional Relevant MeSH Terms

Nontuberculous Mycobacterium Infection