Auto/Allo Tandem Transplant for Relapsed B-NHL

November 3, 2023 updated by: New York Medical College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will obtain the following information from the patient's medical records: clinical factors including age at presentation, gender, clinical presentation, laboratory and pathology data, lymphoma diagnosis, clinical staging criteria, anti-cancer therapy as well as supportive care medicines, complications of therapy (adverse events graded from CTCAE v4.0), and hematopoietic stem cell transplantation therapy (chemotherapy, donor source, cell dose), course (engraftment, GVHD, chimerism), and follow-up (disease status).

Study Type

Observational

Enrollment (Actual)

12

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.

Eligibility Criteria

Ages Eligible for Study

1 second to 29 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

B-NHL patients who received MAC/AutoSCT and a RIC/AlloSCT

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events related to study treatment (safety)
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Medical College

Investigators

  • Principal Investigator: Mitchell Cairo, MD, New York Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L 11,813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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