NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

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.

Conditions

• Lymphoblastic Lymphoma

Interventions

DRUG

Prednisone

Given orally (PO).

DRUG

Vincristine

Given intravenously (IV).

DRUG

Daunorubicin

Given IV.

DRUG

PEG-asparaginase

Given intramuscularly (IM) or IV.

DRUG

Erwinia asparaginase

Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.

DRUG

Doxorubicin

Given IV.

DRUG

Cyclophosphamide

Given IV.

DRUG

Cytarabine

Given IV or IT.

DRUG

Thioguanine

Given PO.

DRUG

Clofarabine

Given IV.

DRUG

Methotrexate

Given IV, IM or IT.

DRUG

Mercaptopurine

Given PO.

DRUG

Dexamethasone

Given PO or IV.

DRUG

Hydrocortisone

Given IT.

DRUG

Etoposide

Given IV.

Sponsors & Collaborators

• National University of Singapore

  collaborator OTHER

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Hiroto Inaba, MD,PhD · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-25

Primary Completion

2021-05-08

Completion

2022-05-31

FDA Drug

Yes

Countries

• United States

Study Locations