Not currently recruiting at UCSF

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

a study on Acute Lymphoblastic Leukemia Leukemia Lymphoma Immunotherapy Traumatic Brain Injury

Summary

Eligibility
for people ages up to 39 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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)

Details

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)

Keywords

T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma, immunotherapy, children, adolescents, young adults, Lymphoma, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Daratumumab

Eligibility

You can join if…

Open to people ages up to 39 years

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California not yet accepting patients
    San Francisco California 94143 United States
  • University of California not yet accepting patients
    Los Angeles California 90095 United States
  • Loma Linda University Children's Hospital accepting new patients
    Loma Linda California 92354 United States
  • Riley Children's Hospital accepting new patients
    Indianapolis Indiana 46202 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
New York Medical College
ID
NCT04972942
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated