RecruitingPhase 1NCT04972942

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

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)


Sponsor

New York Medical College

Enrollment

30 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted immunotherapy approach after stem cell transplant in children, adolescents, and young adults with high-risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma that has come back or is not responding to treatment. **You may be eligible if...** - You are between 0 and 39 years old - You have T-cell ALL in second or later remission (less than 5% cancer cells remaining), or T-cell lymphoblastic lymphoma that has achieved a complete response after re-induction treatment - You have a matched donor identified for an allogeneic stem cell transplant - You have recovered from prior chemotherapy side effects - Your organ function meets the minimum requirements **You may NOT be eligible if...** - You have had a prior stem cell transplant (autologous or allogeneic) - You have an active, uncontrolled infection - You have known allergies to key study medications (such as mannitol, corticosteroids, or monoclonal antibodies) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

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: 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24) 3. Maintenance: DARA every 4 weeks (Stop at Day +270)


Locations(16)

Phoenix Children's Hospital

Phoeniz, Arizona, United States

Loma Linda University Children's Hospital

Loma Linda, California, United States

University of California

Los Angeles, California, United States

University of California

San Francisco, California, United States

Children's Hospital Colordao

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Florida

Gainsville, Florida, United States

John Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Riley Children's Hospital

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

New York Medical College

Vallhala, New York, United States

Nationwide Children's Hosptial

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04972942


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