Clinical trial · Interventional
Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma
Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma. Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response. Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt's Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
| HIV | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEAM conditioning | Drug | — | UNRESOLVED |
| Consolidation Phase (on day +50) | Drug | — | UNRESOLVED |
| Consolidation radiotherapy | Radiation | — | UNRESOLVED |
| Induction Phase | Drug | — | UNRESOLVED |
| Intensification phase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intensive short term immuno-chemotherapy
- description
- Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
- interventionNames
- Drug: Induction Phase
- Drug: Consolidation Phase (on day +50)
- Drug: Intensification phase
- Drug: BEAM conditioning
- Radiation: Consolidation radiotherapy
Primary outcomes (1)
- measure
- evaluation of activity of the induction phase in terms of complete remission rate
- timeFrame
- at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days
- description
- Objective lymphoma response achieved after the induction phase of the experimental treatment.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of Burkitt's lymphoma (WHO 2008) * HIV sero-positivity * Age ≥18 and ≤60 years * ECOG-PS ≤3 Exclusion Criteria: * CNS parenchymal involvement * Absolute neutrophil count \<1.000 cells/μL and platelets count \<75 × 109/L (Burkitt unrelated) * Creatinine \>1,5N (Burkitt unrelated) * SGOT and/or SGTP \>2,5N (Burkitt unrelated) * Bilirubin \>2N (Burkitt unrelated) * Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance * Significant cardiac disease or acute myocardial infarction in the last 12 months * Severe active infection (except for HBV and/or HCV co-infection)
References
Publications (0)
Data not yet available