NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Information source: St. Jude Children's Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoblastic Lymphoma
Intervention: 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 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: St. Jude Children's Research Hospital Official(s) and/or principal investigator(s):
Hiroto Inaba, MD,PhD, Principal Investigator, Affiliation: St. Jude Children's Research Hospital
Overall contact:
Hiroto Inaba, MD,PhD, Phone: 1-866-278-5833, Email: info@stjude.org
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
Clinical Details
Official title: NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Event-free survival (EFS).
Secondary outcome: Overall survival (OS).Percentage of lymphoblastic cells in bone marrow at diagnosis (MDD) and at day 8 of therapy (MRD).
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).
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): 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 and Contacts
Hiroto Inaba, MD,PhD, Phone: 1-866-278-5833, Email: info@stjude.org
Rady Children's Hospital San Diego, San Diego, California 92123, United States; Recruiting
Catherine E. Madigan, MD, Phone: 858-966-5811, Email: cmadigan@rchsd.org
Catherine E. Madigan, MD, Principal Investigator
St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States; Recruiting
Hiroto Inaba, MD,Ph.D, Phone: 866-278-5833, Email: info@stjude.org
Hiroto Inaba, MD,Ph.D, Principal Investigator
Additional Information
St. Jude Children's Research Hospital Clinical Trials Open at St. Jude
Starting date: May 2012
Last updated: March 31, 2015
|
