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NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Lymphoblastic Lymphoma

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Trial Information

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma


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).


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival (EFS).

Outcome Description:

Kaplan-Meier survival curve estimate.

Outcome Time Frame:

Two years post therapy.

Safety Issue:

No

Principal Investigator

Hiroto Inaba, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

NHL16

NCT ID:

NCT01451515

Start Date:

May 2012

Completion Date:

October 2024

Related Keywords:

  • Lymphoblastic Lymphoma
  • Lymphoblastic lymphoma
  • Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794