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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
T-cell Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Valhalla

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 0-39yrs
  • * T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy
  • * Planned allogeneic stem cell transplantation with donor identified
  • * Performance status ≥ 60%
  • * Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  • * Meet organ function requirements
  • * Signed IRB approved informed consent
  • * May not have had a prior autologous or allogenic stem cell transplant
  • * May not have uncontrolled, systemic infection at the time of enrollment
  • * Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients
  • * Must not be pregnant or actively breast feeding
  • * Seropositive for HIV, hepatitis B or hepatitis C
  • * COPD
  • * Asthma
  • * Clinically significant cardiac disease

Ages Eligible for Study

to 39 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2028-09