Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma (CARMEN)

Andres J. M. Ferreri

Status and phase: Completed; Phase 2

Conditions: HIV; Burkitt's Lymphoma

Treatments: Drug: Intensification phase; Drug: BEAM conditioning; Radiation: Consolidation radiotherapy; Drug: Consolidation Phase (on day +50); Drug: Induction Phase

Study type: Interventional

Funder types: Other

Identifiers

NCT01516593

CARMEN

Details and patient eligibility

About

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.

Full description

The activity of feasibility of the proposed program will be assessed in HIV+ patients with Burkitt lymphoma with the aim to improve tolerability, minimize source consuming and supporting treatment and redu ce late sequels. Available combinations in this setting are really source demanding and toxic combinations showing high rates of septic complication and a treatment-related mortality of near 20%.

Enrollment: 19 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 1 patient group

intensive short term immuno-chemotherapy

Experimental group

Description:

Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.

Treatment:

Drug: Consolidation Phase (on day +50)

Radiation: Consolidation radiotherapy

Drug: BEAM conditioning

Drug: Intensification phase

Drug: Induction Phase

Sponsor of this trial

Lead Sponsor

Andres J. M. Ferreri