Status:
COMPLETED
NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National University of Singapore
Conditions:
Lymphoblastic Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
This is a phase II clinical trial using risk-adapted therapy. The treatment is acute lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of induction, consolidation, and ...
Detailed Description
TREATMENT PLAN Treatment will consist of 3 main phases: remission induction, consolidation \[only for patients with any central nervous system (CNS) disease and/or testicular involvement\], and conti...
Eligibility Criteria
Inclusion
- Diagnosis of newly diagnosed lymphoblastic lymphoma (patients must have \<25% tumor cells in bone marrow by morphology)
- Age ≤ 21 years
- Limited prior therapy, including systemic glucocorticoids for 1 week or less, 1 dose of vincristine, emergency radiation therapy to the mediastinum, and 1 dose of IT chemotherapy. Other circumstances must be cleared by PI or co-PI.
- Written, informed consent and assent following guidelines of the Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP).
Exclusion
- Participants with prior therapy, other than therapy specified in 3 above.
- Participants who are pregnant or lactating.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Key Trial Info
Start Date :
May 25 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01451515
Start Date
May 25 2012
End Date
May 31 2022
Last Update
June 28 2022
Active Locations (2)
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1
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105