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Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
HIV, Burkitt's Lymphoma

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Trial Information

Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma


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%.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

evaluation of activity of the induction phase in terms of complete remission rate

Outcome Description:

Objective lymphoma response achieved after the induction phase of the experimental treatment.

Outcome Time Frame:

at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days

Safety Issue:

Yes

Principal Investigator

Andrés JM Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Raffaele Scientific Institute, Milano, Italy

Authority:

Italy: Ethics Committee

Study ID:

CARMEN

NCT ID:

NCT01516593

Start Date:

November 2011

Completion Date:

August 2015

Related Keywords:

  • HIV
  • Burkitt's Lymphoma
  • HIV
  • Burkitt's lymphoma
  • intensive
  • short term
  • immuno-chemotherapy
  • HIV-positive patients with Burkitt's lymphoma
  • Burkitt Lymphoma
  • HIV Seropositivity
  • Lymphoma

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