NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
2 other identifiers
interventional
23
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2012
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 13, 2011
CompletedStudy Start
First participant enrolled
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2021
CompletedResults Posted
Study results publicly available
May 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJune 28, 2022
June 1, 2022
9 years
August 17, 2011
March 24, 2022
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Probability of Event-free Survival (EFS)
For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method. Please note the unit of measurement of probabilities are percentages.
Two years post therapy.
Secondary Outcomes (3)
Probability of Overall Survival (OS)
Two years post therapy.
Minimal Disseminated Disease (MDD)
At Diagnosis
Minimal Residual Disease (MRD)
Day 8
Study Arms (1)
Treatment
EXPERIMENTALPatients will undergo treatment as described in the intervention section. Interventions include: * Remission induction: prednisone, vincristine, daunorubicin, PEG-asparaginase (or Erwinia asparaginase), IT-MHA (Methotrexate, hydrocortisone, and cytarabine), cyclophosphamide, cytarabine, thioguanine * Consolidation: PEG-asparaginase, High-dose methotrexate (HD-MTX), mercaptopurine * Postremission continuation: Dexamethasone, doxorubicin, vincristine, mercaptopurine, PEG-asparaginase, cyclophosphamide, cytarabine, methotrexate * Reintensification: dexamethasone, cytarabine, etoposide, PEG-asparaginase, clofarabine, cyclophosphamide * All patients receive IT-MHA on days 1 and 15. Some patients also receive additional IT-MHA on days 8 and 22.
Interventions
Given intramuscularly (IM) or IV.
Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.
Given IV.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hiroto Inaba, MD, PhD
- Organization
- St. Jude Children's Research Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroto Inaba, MD,PhD
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2011
First Posted
October 13, 2011
Study Start
May 25, 2012
Primary Completion
May 8, 2021
Study Completion
May 31, 2022
Last Updated
June 28, 2022
Results First Posted
May 23, 2022
Record last verified: 2022-06