Acute Lymphoblastic LeukemiaPhase 4NCT00797810
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
A Phase 4 study testing Rituximab in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma
- What is being tested?
- Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2006to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute of Haematology "L. e A. Seragnoli"
Bologna
Giovanni Martinelli, MD
About this study
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.
- Being tested
- Rituximab
- Keywords
- Acute lymphoblastic leukemia of the mature B-cell type, High-grade non-Hodgkin's lymphoma
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF
| Study group | Role | What they receive |
|---|---|---|
| therapy | Experimental | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of the tolerability and efficacy of new therapy elements to improve remission
Rates, overall survival and remission duration
Administration of anti-CD20 (rituximab ®) together with combination chemotherapy
Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)
Prophylactic administration of G-CSF after every cycle of chemotherapy
Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor
Secondary outcomes (4)
Test of the age-adapted therapy stratification according to biological age
(18< age <55)
Definition of prognostic factors
Setting up of a central reference pathology panel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Martinelli, MD, Principal investigator, Institute of Haematology "L.e A. Seragnoli" Bologne-Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797810
- Sponsor's protocol ID
- HEMOS ALL1105
- Status last verified
- Sep 2009
- First submitted
- 24 Nov 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
- ClinicalTrials.gov ID
- NCT00797810
- Acronym / sponsor ID
- HEMOS ALL1105
- Keywords
- Acute lymphoblastic leukemia of the mature B-cell type, High-grade non-Hodgkin's lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Dec 2006
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy | Experimental | Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acute lymphoblastic leukemia of the mature B-cell type (L3-ALL)
- High-grade non-Hodgkin's lymphoma of the following subtypes (WHO classification)
- Age = 18 years
- Patient's Informed Consent
Key exclusion criteria (14 listed)
- Serious complications caused by leukemia/ lymphoma or by a second illness: e.g.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF | Drug | therapy |
Primary outcome
Test of the tolerability and efficacy of new therapy elements to improve remission
Rates, overall survival and remission duration
Administration of anti-CD20 (rituximab ®) together with combination chemotherapy
Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)
Prophylactic administration of G-CSF after every cycle of chemotherapy
Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor
4 secondary outcomes
Test of the age-adapted therapy stratification according to biological age
(18< age <55)
Definition of prognostic factors
Setting up of a central reference pathology panel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Martinelli, MD principal investigator
Institute of Haematology "L.e A. Seragnoli" Bologne-Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rituximab in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Martinelli, MD (0516363829, gmartino@alma.unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of the tolerability and efficacy of new therapy elements to improve remission. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009; AzTrials last refreshed its copy on 8 Nov 2026.