NHL16: Study for Newly Diagnosed Patients with Acute Lymphoblastic Lymphoma

Combination Chemotherapy in Treating Younger Patients with Newly Diagnosed Acute Lymphoblastic Lymphoma

Categories:

Leukemia / Lymphoma

Phase I/II

Diseases Treated:

Acute lymphoblastic leukemia

Eligibility Overview:

  • 21 years of age or younger
  • Newly diagnosed lymphoblastic lymphoma
  • Has received one week or less prior treatment for lymphoblastic lymphoma
  1. Brief Summary

    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.

    Primary Objective

    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.

    Trial Outline

    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)

    Study Arms

    Experimental: Treatment

    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
    • 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.

    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

    Study Design

    • Endpoint Classification: Safety/Efficacy Study
    • Intervention Model: Single Group Assignment
    • Masking: Open Label
    • Primary Purpose: Treatment
  2. 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).

    Treatment

    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.   

    Eligibility overview

    • 21 years of age or younger
    • Newly diagnosed lymphoblastic lymphoma
    • Has received one week or less prior treatment for  lymphoblastic lymphoma
  3. NHL16  Quick View

    Sponsor

    St. Jude Children’s Research Hospital

    Collaborator

    National University, Singapore

    ClinicalTrials.gov identifier

    NCT01451515

    Trial start date

    May 2012

    Estimated enrollment

    72

    Study type

    Interventional

    Study phase

    Phase 2

    Conditions

    Lymphoblastic Lymphoma

    Ages

    Up to 21 years

    Principal investigator

    Hiroto Inaba, MD, PhD

    Study sites

    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
    1-888-226-4343
    referralinfo@stjude.org

Contact

Hiroto Inaba, MD, PhD

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

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

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.