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NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01451515
Recruitment Status : Active, not recruiting
First Posted : October 13, 2011
Last Update Posted : December 3, 2019
National University, Singapore
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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 determine event-free and overall survival
  • Investigate the relationship between Day 8 MRD and MDD results and EFS

Condition or disease Intervention/treatment Phase
Lymphoblastic Lymphoma Drug: 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Actual Study Start Date : May 25, 2012
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Treatment

Patients 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.
Drug: Prednisone
Given orally (PO).
Other Name: Prednisolone

Drug: Vincristine
Given intravenously (IV).
Other Names:
  • Oncovin®
  • Vincristine sulfate

Drug: Daunorubicin
Given IV.
Other Names:
  • Daunomycin
  • Cerubidine®

Drug: PEG-asparaginase
Given intramuscularly (IM) or IV.
Other Names:
  • Pegaspargase
  • Oncaspar®

Drug: Erwinia asparaginase
Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.
Other Name: Erwinase®

Drug: Doxorubicin
Given IV.
Other Name: Adriamycin®

Drug: Cyclophosphamide
Given IV.
Other Name: Cytoxan®

Drug: Cytarabine
Given IV or IT.
Other Names:
  • Ara-C
  • Cytosar-U®

Drug: Thioguanine
Given PO.
Other Name: Purine antimetabolite

Drug: Clofarabine
Given IV.
Other Names:
  • Cl-F-Ara-A
  • CAFdA
  • 2-Chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)-9H-purin-6-amine
  • Clofarex
  • Clolar^TM

Drug: Methotrexate
Given IV, IM or IT.
Other Names:
  • MTX
  • High-dose methotrexate (HD-MTX)

Drug: Mercaptopurine
Given PO.
Other Names:
  • 6-MP
  • Purinethol®

Drug: Dexamethasone
Given PO or IV.
Other Name: Decadron®

Drug: Hydrocortisone
Given IT.
Other Name: Cortef®

Drug: Etoposide
Given IV.
Other Names:
  • VP-16
  • Vepesid®

Primary Outcome Measures :
  1. Event-free survival (EFS). [ Time Frame: Two years post therapy. ]
    Kaplan-Meier survival curve estimate.

Secondary Outcome Measures :
  1. Overall survival (OS). [ Time Frame: Two years post therapy. ]
    Kaplan-Meier survival curve estimate.

  2. Percentage of lymphoblastic cells in bone marrow at diagnosis (MDD) and at day 8 of therapy (MRD). [ Time Frame: Two years post day 8. ]
    Cox regression modeling of EFS with MRD and MDD as explanatory variables.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of newly diagnosed lymphoblastic lymphoma (patients must have <25% tumor cells in bone marrow by morphology)
  2. Age ≤ 21 years
  3. 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.
  4. 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:

  1. Participants with prior therapy, other than therapy specified in 3 above.
  2. Participants who are pregnant or lactating.
  3. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451515

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United States, California
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
National University, Singapore
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Principal Investigator: Hiroto Inaba, MD,PhD St. Jude Children's Research Hospital
Additional Information:
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Responsible Party: St. Jude Children's Research Hospital Identifier: NCT01451515    
Other Study ID Numbers: NHL16
NCI-2012-00496 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Lymphoblastic lymphoma
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Immunosuppressive Agents
Immunologic Factors