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

  • Status
    Accepting Candidates
  • Age
    N/A - 39 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Description

Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor.

Daratumumab (DARA) treatment post-HCT:

Phase 1: 3 dose levels to determine safety (15 patients)

Dose expansion cohort (DEC): Further evaluation of PK and PD (correlative studies/exploratory endpoints) to guide future selection of RP2D (15 patients)

Treatment Schedule:

  1. Induction: DARA IV weekly x 8 doses (Weeks 1-8.

  2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24.

  3. Maintenance: DARA IV every 4 weeks (Stop at Day +270.

Details

Full study title A Phase 1 Trial of Targeted Immunotherapy with Daratumumab Following Myeloablative Total Body Irradiation (TBI)-Based Conditioning and Allogeneic Hematopoietic Cell Transplantation in Children, Adolescents and Young Adults with High-Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (T-ALL/T-LLy) (ALLO-T-DART)
Protocol number OCR45287
ClinicalTrials.gov ID NCT04972942
Phase Phase 1

Eligibility

Inclusion Criteria:

  • 0-39yrs

  • T-cell ALL in second or subsequent remission (鈮� 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 鈮� 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

Lead researcher

  • Jordan Milner, MD
    Pediatric Hematologist/Oncologist (Child Cancer Specialist)

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