This is a phase 2 clinical trial using risk-adapted therapy. The treatment is acute lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens 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.
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.
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 continuation.
- Induction (6-7 weeks)
- Consolidation for participants with CNS involvement or those with testicular disease only (10 weeks)
- Reintensification - Participants with residual disease any time after induction therapy may receive 1-2 cycles of re-intensification therapy and may proceed to allogeneic stem cell transplant if suitable donor is available
- Continuation Therapy (98-120 weeks)
- Intrathecal Chemotherapy (Days 1 and 15; if needed also on Days 8 and 22)
- 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
- 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.
- 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)
- 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
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Single Group Assignment
- Masking: Open Label
- Primary Purpose: Treatment
About this clinical trial
NHL16 is a Phase II clinical trial aimed at treating your child’s newly diagnosed lymphoblastic lymphoma. Lymphoblastic lymphoma is a fast-growing form of non-Hodgkin lymphoma, a cancer that can affect the lymph nodes and white blood cells. These cells fight infection and help protect the body against disease. Effective treatment for lymphoblastic lymphoma, resulting in long-term remission (no signs or symptoms of disease), occurs when patients are treated with several strong chemotherapy drugs. In this trial, researchers will look at developing better treatments while trying to reduce some of the possible long-term side effects that are common with strong chemotherapy drugs.
Purpose of this clinical trial
The main goal is to try to improve the cure rate of children with lymphoblastic lymphoma. To do this, St. Jude researchers will provide treatment and watch your child’s response to treatment closely using special tests that will help decide if more therapy is needed (high-risk participants) to keep the lymphoblastic lymphoma from coming back after treatment and which participants will need less therapy (low-risk participants).
Your child’s specific lymphoblastic lymphoma diagnosis will determine the treatment plan that will be used. First, all participants will receive several tests to find out:
- What type of lymphoma cell is present (T cell or B cell)
- If lymphoma cells are in the blood, bone marrow, or spinal fluid at the time of diagnosis
Next, your child will be placed into one of three groups based on whether test results show your child’s disease has a high, standard or low risk of coming back after treatment.
Participants in all of the treatment groups will be given several strong chemotherapy drugs to get rid of lymphoma cells in the lymph nodes and bone marrow. This is called remission induction treatment. All participants will receive maintenance chemotherapy over several months to kill any leftover lymphoma cells that may still be present in the body after remission induction treatment and to keep their lymphoblastic lymphoma from coming back at a later time.
- 21 years of age or younger
- Newly diagnosed lymphoblastic lymphoma
- Has received one week or less prior treatment for lymphoblastic lymphoma
NHL16 Quick View
St. Jude Children’s Research Hospital
National University, Singapore
Trial start date
Up to 21 years
Hiroto Inaba, MD, PhD
St. Jude Children’s Research Hospital and Rady Children's Hospital San Diego
For a consultation or to discuss NHL16
St. Jude Physician/Patient Referral Office
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.