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Auto/Allo Tandem Transplant for Relapsed B-NHL

Sponsor
New York Medical College (Other)
Overall Status
Unknown status
CT.gov ID
NCT03205657
Collaborator
(none)
40
Enrollment
43
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: auto transplant followed by allo transplant

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2019

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events related to study treatment (safety) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 29 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • New York Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
New York Medical College
ClinicalTrials.gov Identifier:
NCT03205657
Other Study ID Numbers:
  • L 11,813
First Posted:
Jul 2, 2017
Last Update Posted:
Jun 21, 2018
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Jun 21, 2018