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Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma


Phase 2
15 Years
N/A
Open (Enrolling)
Both
Burkitt Lymphoma, B-Cell Acute Lymphoblastic Leukemia

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Trial Information

Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma


Cycle A1: prednisone-cyclophosphamide pre-phase (5 days), Rituximab on day 0, chemotherapy
on days 1-5 (dexamethasone, iphosphamide, vincristine, high-dose methotrexate, triple
intrathecal therapy).

Cycle B1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vincristine,
cyclophosphamide, high-dose methotrexate, adriamycin, triple intrathecal therapy) Cycle C1:
Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vindesine, high-dose
methotrexate, etoposide, high-dose cytarabine).

Cycle A2: like cycle A1, without pre-phase. Cycle B2: like cycle B1. Cycle C2: like cycle
C1. Cycle C2 is followed by two additional Rituximab injections.

Notes:

1. patients with stage I-II disease without mediastinal tumor or extranodal involvement
receive only the first 4 cycles (A1 to A2).

2. patients aged >55 years do not receive cycles C (sequence: A1, B1, A2, B2, A3, B3 or
A1, B1, A2, B2 if limited stage, with reduced-dose methotrexate).


Inclusion Criteria:



- Burkitt's leukemia or lymphoma (new diagnosis)

- Written informed consent

- Age > 15 years

Exclusion Criteria:

- pre-treated Burkitt's leukemia or lymphoma

- psychiatric disorders

- active second malignancy

- pregnancy

- absence of patient's written informed consent

- participation in other studies that interfere with the study therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Description:

Percentage of patients alive without disease at 5 years from date of diagnosis

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Renato Bassan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC Ematologia Ospedali Riuniti di Bergamo

Authority:

Italy: Ministry of Health

Study ID:

NILG 2009-012950-19

NCT ID:

NCT01290120

Start Date:

November 2002

Completion Date:

December 2012

Related Keywords:

  • Burkitt Lymphoma
  • B-cell Acute Lymphoblastic Leukemia
  • Burkitt Lymphoma
  • B-ALL
  • Adult patients
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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