NCT03205657

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

5.6 years

First QC Date

May 11, 2017

Last Update Submit

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

Age0 Years - 29 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Mitchell Cairo, MD

    New York Medical College

    PRINCIPAL INVESTIGATOR

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