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

Summary

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.

Eligibility

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

Conditions3

Locations16 sites

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