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

RecruitingPhase 1Ages any - 39 YearsAllNew York Medical College
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 0-39yrs * T-cell ALL in second or subsequent remission (โ‰ค 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 โ‰ฅ 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
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What it tests

  • Daratumumab
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Where

16 sites
Phoenix Children's Hospital
Phoeniz, United States
Loma Linda University Children's Hospital
Loma Linda, United States
University of California
Los Angeles, United States
University of California
San Francisco, United States
Children's Hospital Colordao
Aurora, United States
Children's National Medical Center
Washington D.C., United States
University of Florida
Gainsville, United States
John Hopkins All Children's Hospital
St. Petersburg, United States

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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