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CompletedNCT03205657Updated Nov 7, 2023

Auto/Allo Tandem Transplant for Relapsed B-NHL

An observational study in Non Hodgkin Lymphoma, sponsored by New York Medical College. Completed. Open to participants aged 0 Years to 29 Years. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by New York Medical College · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
12
Ages
0 Years to 29 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Non Hodgkin Lymphoma
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In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's enrollment of 12 is below the median of 150 across 159 observational studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

New York Medical College is the lead sponsor of 69 studies on the registry; 23 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 29 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • None
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • Procedureauto transplant followed by allo transplant

    patients who got MAC conditioning with auto SCT followed by RIC followed by alloSCT for mature B-NHL

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What researchers measure

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.

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 36260003 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03205657
Lead sponsor
New York Medical College
Responsible party
Sponsor
First posted
Jul 2, 2017
Start date
Jun 1, 2016
Primary completion
Dec 31, 2021
Completion
Aug 31, 2022
Last update
Nov 7, 2023

Study contacts

Mitchell Cairo, MD
principal investigator · New York Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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