RECRUITING

Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.

Official Title

Phase I Trial of Targeted Immunotherapy With Daratumumab Following Myeloablative TBI-Based Conditioning and AlloHCT in Children, Adolescents and Young Adults With High Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (ALLO-T-DART)

Quick Facts

Study Start:2023-05-22
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04972942

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.

Ages Eligible for Study:Not specified to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 0-39yrs
  2. * T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy
  3. * Planned allogeneic stem cell transplantation with donor identified
  4. * Performance status ≥ 60%
  5. * Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  6. * Meet organ function requirements
  7. * Signed IRB approved informed consent
  1. * May not have had a prior autologous or allogenic stem cell transplant
  2. * May not have uncontrolled, systemic infection at the time of enrollment
  3. * Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients
  4. * Must not be pregnant or actively breast feeding
  5. * Seropositive for HIV, hepatitis B or hepatitis C
  6. * COPD
  7. * Asthma
  8. * Clinically significant cardiac disease

Contacts and Locations

Study Contact

Lauren Harrison, RN, MSN
CONTACT
6172857844
lauren_harrison@nymc.edu
Erin Morris, RN
CONTACT
7149645359
erin_morris@nymc.edu

Principal Investigator

Mitchell Cairo, MD
STUDY_CHAIR
New York Medical College
Troy Quigg, DO
STUDY_CHAIR
Helen DeVos Children's Hospital
Allyson Flower, MD
STUDY_CHAIR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

New York Medical College
Valhalla, New York, 10595
United States

Collaborators and Investigators

Sponsor: New York Medical College

  • Mitchell Cairo, MD, STUDY_CHAIR, New York Medical College
  • Troy Quigg, DO, STUDY_CHAIR, Helen DeVos Children's Hospital
  • Allyson Flower, MD, STUDY_CHAIR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2023-05-22
Study Completion Date2028-09

Study Record Updates

Study Start Date2023-05-22
Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

  • immunotherapy
  • children
  • adolescents
  • young adults

Additional Relevant MeSH Terms

  • T-cell Acute Lymphoblastic Leukemia
  • T-Cell Acute Lymphoblastic Lymphoma