Phase 2
N=23
NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Lymphoblastic Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01451515 ↗Enrolled (actual)
23
Serious AEs
4.4%
Results posted
May 2022
Primary outcome: Primary: Probability of Event-free Survival (EFS) — 91.7; 71.4; 100; 86.96 percentage of event-free patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prednisone (Drug); Vincristine (Drug); Daunorubicin (Drug); PEG-asparaginase (Drug); Erwinia asparaginase (Drug); Doxorubicin (Drug); Cyclophosphamide (Drug); Cytarabine (Drug); Thioguanine (Drug); Clofarabine (Drug); Methotrexate (Drug); Mercaptopurine (Drug); Dexamethasone (Drug); Hydrocortisone (Drug); Etoposide (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Event-free Survival (EFS) |
91.7; 71.4; 100; 86.96 | — |
| SECONDARY Probability of Overall Survival (OS) |
91.7; 71.4; 100; 86.96 | — |
| SECONDARY Minimal Disseminated Disease (MDD) |
4; 2; 0; 1; 3; 4 | — |
| SECONDARY Minimal Residual Disease (MRD) |
8; 4; 0; 0; 1; 4 | — |
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 continuation (maintenance) phases delivered over 24-30 months. Participants will be classified into 3 treatment stratums, based on bone marrow/peripheral blood lymphoma cells involvement at diagnosis and day 8 for T-lymphoblastic lymphoma and bone marrow/peripheral blood lymphoma cells involvement at diagnosis for B-lymphoblastic lymphoma.
The Primary Objective of this study is:
To improve the outcome of children with lymphoblastic lymphoma (LL) who have minimal disseminated disease (MDD) equal to or more than 1% at diagnosis by using MDD- and minimal residual disease (MRD)- based risk-adapted therapy.
The Secondary Objectives of this study are:
* To estimate the event-free survival and overall survival of children with lymphoblastic lymphoma who are treated with MDD- or MRD-based risk- directed therapy.
* To evaluate the prognostic value of levels of MDD at diagnosis and MRD on day 8 of remission induction.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01451515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.