Auto/Allo Tandem Transplant for Relapsed B-NHL
MAC and autoHSCT, Targeted Immunotherapy and RIC alloHSCT in Children, Adolescents, and Young Adults (CAYA) With Poor-risk Refractory/Relapsed Mature B-NHL: A Retrospective Chart Review
1 other identifier
observational
12
0 countries
N/A
Brief Summary
The investigators plan to perform a retrospective review of patients with poor risk relapsed/refractory B-NHL having received HSCT and targeted immunotherapy at the Maria Fareri Children's Hospital between January 1, 2012 and June 1, 2015. The investigators will review the clinical records and collect the data with de-identified medical information from our HSCT clinical research database.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedNovember 7, 2023
November 1, 2023
5.6 years
May 11, 2017
November 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events related to study treatment (safety)
Adverse events (according to CTCAE 4.0) will be reviewed for all as well as outcome data retrospectively to determine if the treatment was equal or better than standard of care for relapse/refractory B-NHL in terms of the number of adverse events reported. Data reviewed will include laboratory values, radiology exams and disease evaluations.
3 years
Interventions
patients who got MAC conditioning with auto SCT followed by RIC followed by alloSCT for mature B-NHL
Eligibility Criteria
B-NHL patients who received MAC/AutoSCT and a RIC/AlloSCT
You may qualify if:
- This analysis will include all children, adolescents, and young adults less than 29 years old with a histologically confirmed diagnosis of B-NHL treated at the Maria Fareri Children's Hospital
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gardenswartz A, Mehta B, El-Mallawany NK, van de Ven C, Hochberg J, Flower A, Morris E, Harrison L, Chu Y, Basso J, Gerard P, Islam H, Ayello J, Baxter-Lowe LA, Cairo MS. Safety and efficacy of combinatorial therapy utilizing myeloablative conditioning and autologous stem cell transplantation, targeted immunotherapy, and reduced intensity conditioning and allogeneic stem cell transplantation in children, adolescents, and young adults with relapsed/refractory mature B-cell non-Hodgkin lymphoma. Leuk Lymphoma. 2023 Jan;64(1):234-237. doi: 10.1080/10428194.2022.2133542. Epub 2022 Oct 19. No abstract available.
PMID: 36260003BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Cairo, MD
New York Medical College
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
July 2, 2017
Study Start
June 1, 2016
Primary Completion
December 31, 2021
Study Completion
August 31, 2022
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share