Trial NCT04972942
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
- Phase
- Phase 1
- Sponsor
- New York Medical College
- Conditions
- T-cell Acute Lymphoblastic Leukemia; T-Cell Acute Lymphoblastic Lymphoma
- Ages
- 0–39 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* 0-39yrsAge
* 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%Performance status
* 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 feedingPregnancy
* Seropositive for HIV, hepatitis B or hepatitis CHIV
* COPD
* Asthma
* Clinically significant cardiac diseaseCardiac
Restrictions found (5)
- AgeOutrightinclusion
age <= 39
Show in the text - CardiacConditionalexclusionShow in the text
- HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
performance status >= 60%
Show in the text - PregnancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Boston Children's Hospital · Boston, Suffolk County