NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Conditions
Lymphoblastic Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
Lymphoblastic lymphoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Prednisone Type: Drug
Name: Vincristine Type: Drug
Name: Daunorubicin Type: Drug
Name: PEG-asparaginase Type: Drug
Name: Erwinia asparaginase Type: Drug
Name: Doxorubicin Type: Drug
Name: Cyclophosphamide Type: Drug
Name: Cytarabine Type: Drug
Name: Thioguanine Type: Drug
Name: Clofarabine Type: Drug
Name: Methotrexate Type: Drug
Name: Mercaptopurine Type: Drug
Name: Dexamethasone Type: Drug
Name: Hydrocortisone Type: Drug
Name: Etoposide Type: Drug
Overall Status
Recruiting
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
Detailed Description
TREATMENT PLAN

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)

TREATMENT SCHEME

T lymphoblastic lymphoma: bone marrow/peripheral blood (BM/PB) involvement (MDD/MRD): Diagnosis: less than 1%; Day 8: +/− (Stratum 1)

- Induction

- Single dose of Cyclophosphamide

- Steroid: prednisone

- Continuation: 98 weeks

T lymphoblastic lymphoma: BM/PB involvement (MDD/MRD): Diagnosis: equal to or greater than 1%; Day 8: − (Stratum 2)

- Induction

- Fractionated Cyclophosphamide

- Steroid: prednisone

- Continuation : 98 weeks

T lymphoblastic lymphoma: BM/PB involvement (MDD/MRD): Diagnosis: equal to or greater than 1%; Day 8: + (Stratum 3)

- Induction

- Fractionated Cyclophosphamide

- Steroid: prednisone and dexamethasone

- Continuation: 120 weeks

B lymphoblastic lymphoma: Stage I-III (Stratum 1)

- Induction

- Single dose of Cyclophosphamide

- Steroid: prednisone

- Continuation: 98 weeks

B lymphoblastic lymphoma: Stage IV or testicular (Stratum 2)

- Induction

- Fractionated Cyclophosphamide

- Steroid: prednisone

- Continuation: 98 weeks

Patients with CNS or testicular involvement will receive Consolidation therapy prior to continuation therapy and receive extended maintenance therapy (120 weeks).

Any patient with detectable disease (MRD, bone marrow or biopsy of residual mass) at the end of induction may be considered for reintensification and/or hematopoietic stem cell transplantation (HSCT).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 21 Years
Minimum Age: N/A
Gender: Both
Criteria: 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.
Locations
Rady Children's Hospital San Diego
San Diego, California, United States
Status: Recruiting
Contact: Catherine E. Madigan, MD - 858-966-5811 - cmadigan@rchsd.org
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Status: Recruiting
Contact: Hiroto Inaba, MD,Ph.D - 866-278-5833 - info@stjude.org
Start Date
May 2012
Completion Date
May 2027
Sponsors
St. Jude Children's Research Hospital
Source
St. Jude Children's Research Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page