NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by St. Jude Children's Research Hospital
National University, Singapore
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
First received: August 17, 2011
Last updated: September 22, 2015
Last verified: September 2015

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

Resource links provided by NLM:

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Event-free survival (EFS). [ Time Frame: Two years post therapy. ] [ Designated as safety issue: No ]
    Kaplan-Meier survival curve estimate.

Secondary Outcome Measures:
  • Overall survival (OS). [ Time Frame: Two years post therapy. ] [ Designated as safety issue: No ]
    Kaplan-Meier survival curve estimate.

  • Percentage of lymphoblastic cells in bone marrow at diagnosis (MDD) and at day 8 of therapy (MRD). [ Time Frame: Two years post day 8. ] [ Designated as safety issue: No ]
    Cox regression modeling of EFS with MRD and MDD as explanatory variables.

Estimated Enrollment: 72
Study Start Date: May 2012
Estimated Study Completion Date: May 2027
Estimated Primary Completion Date: May 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 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 or IT.
Other Names:
  • MTX
  • Hihg-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®

  Show Detailed Description


Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451515

Contact: Hiroto Inaba, MD,PhD 1-866-278-5833 referralinfo@stjude.org

United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Catherine E. Madigan, MD    858-966-5811    cmadigan@rchsd.org   
Principal Investigator: Catherine E. Madigan, MD         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Hiroto Inaba, MD,Ph.D    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Hiroto Inaba, MD,Ph.D         
Sponsors and Collaborators
St. Jude Children's Research Hospital
National University, Singapore
Principal Investigator: Hiroto Inaba, MD,PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01451515     History of Changes
Other Study ID Numbers: NHL16, NCI-2012-00496
Study First Received: August 17, 2011
Last Updated: September 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Lymphoblastic lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
BB 1101
Cortisol succinate
Dexamethasone 21-phosphate
Dexamethasone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on October 13, 2015