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

Launched by NEW YORK MEDICAL COLLEGE · Jul 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for children, adolescents, and young adults who have high-risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Specifically, the trial is looking at the safety of a targeted immunotherapy drug called daratumumab (DARA) given after total body irradiation (TBI) and a type of stem cell transplant known as allogeneic hematopoietic cell transplantation (HCT). The goal is to see how well this treatment works and to understand how the immune system responds during and after the therapy.

To be eligible for this trial, participants need to be between 0 and 39 years old and have specific types of T-cell leukemia or lymphoma that are in remission or have responded well to previous treatments. They should be planning to undergo a stem cell transplant and have fully recovered from any side effects of past treatments. Throughout the study, participants will have their health monitored closely, including their immune system's recovery and any changes in their condition after receiving DARA. It's important to note that individuals with certain health conditions or previous transplants may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion 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 (including secondary malignancy)
• • 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
• Exclusion Criteria:
• • 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