Auto/Allo Tandem Transplant for Relapsed B-NHL

Non Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205657
• Other study ID #: L 11,813
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2023
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 31, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 0 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Procedure:
• auto transplant followed by allo transplant
patients who got MAC conditioning with auto SCT followed by RIC followed by alloSCT for mature B-NHL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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