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Status unknownNCT00797810Updated Sep 15, 2009

Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults

A Phase 4 interventional study of Rituximab in Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, sponsored by University of Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-15.

Sponsored by University of Bologna · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group

  • Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3).
  • Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement.
  • In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years
  • The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.
02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma

Keywords

  • Acute lymphoblastic leukemia of the mature B-cell type
  • High-grade non-Hodgkin's lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 25 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute lymphoblastic leukemia of the mature B-cell type (L3-ALL)

  • High-grade non-Hodgkin's lymphoma of the following subtypes (WHO classification)

    • Burkitt's lymphoma (including atypical Burkitt's lymphoma)
    • Precursor B-lymphoblastic lymphoma
    • Anaplastic large-cell lymphoma (Ki1+, B-, T- oder Null-cell-type)
    • Mediastinal large B-cell-lymphoma (subtype of diffuse large B-cell lymphoma)
  • Age = 18 years
  • Patient's Informed Consent

Exclusion criteria

Exclusion Criteria:

  • Serious complications caused by leukemia/ lymphoma or by a second illness: e.g.

    • Severe, unmanageable complications such as sepsis, pneumonia with oxygen deficiency,
    • Shock, hemorrhage at the time of diagnosis
    • Renal insufficiency from leukemia/lymphoma-unrelated causes
    • Severe cardiac or hepatic insufficiency
    • Severe obstructive or restrictive lung disease that would compromise patient's treatment with intensified chemotherapy
    • HIV infection
    • Secondary lymphoma following prior chemotherapy/ radiotherapy or an active second malignancy
    • Known severe allergy to foreign proteins
  • Cytostatic pretreatment for B-ALL/lymphoma (exceptions: short-term administration of steroids = 7 days, single administration of vincristine or cyclophosphamide, one cycle of CHOP, a single administration in an emergency of other cytostatic agents) for another malignant disease within the last 5 years
  • Pregnancy/ nursing period
  • Severe psychiatric illness or other circumstances giving ground to the assumption that a patient cannot give his consent to therapy or act co-operatively
  • Absence of patient's informed consent
  • Participation in another clinical study that would possibly interfere with study therapy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    therapy

    Drug: Rituximab

Interventions

  • DrugRituximab

    Also known as: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF

06

What researchers measure

Primary outcomes

  1. Test of the tolerability and efficacy of new therapy elements to improve remission

  2. Rates, overall survival and remission duration

  3. Administration of anti-CD20 (rituximab ®) together with combination chemotherapy

  4. Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)

  5. Prophylactic administration of G-CSF after every cycle of chemotherapy

  6. Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor

Secondary outcomes

  1. Test of the age-adapted therapy stratification according to biological age

  2. (18< age <55)

  3. Definition of prognostic factors

  4. Setting up of a central reference pathology panel

07

Study locations

1 of 1 sites recruiting
  • Institute of Haematology "L. e A. Seragnoli"
    Bologna, Italy
    • Giovanni Martinelli, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00797810
Lead sponsor
University of Bologna
First posted
Nov 25, 2008
Start date
Dec 2006
Last update
Sep 15, 2009

Study contacts

Giovanni Martinelli, MD
Contact
gmartino@alma.unibo.it
0516363829
Giovanni Martinelli, MD
principal investigator · Institute of Haematology "L.e A. Seragnoli" Bologne-Italy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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