drugset / Trial / NCT01468740

Prospective Study on HIV-related Hodgkin Lymphoma

NCT01468740

NaSingle-groupOpen-labelTreatment

Summary

Standard therapy for HIV-related Hodgkin lymphoma (HIV-HL) has not been defined. This trial was initiated to investigate a risk adapted treatment strategy in patients (pts) with HIV-HL as established in HIV-negative patients with HL. Treatment schedule: * Early stage favorable Hodgkin Lymphoma (HL): 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 30 Gy involved field (IF) radiation * Early stage unfavorable HL: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline or 4 cycles of ABVD plus 30 Gy IF radiation * Advanced HL: 8 cycles of BEACOPP-baseline. BEACOPP should be replaced by ABVD in pts with far advanced HIV-infection. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation. * Primary outcome measure: tolerability, treatment-related mortality * Secondary outcome measure: complete remission rate, progression-free survival (PFS), overall survival (OS).

Timeline

Start
2004-03
Primary completion
2012-02
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown
Subject Cyclophosphamide Other / unclassified
Subject Dacarbazine Small molecule
Subject Doxorubicin Other / unclassified
Subject Etoposide Small molecule
Subject Prednisone Other / unclassified
Subject Vinblastine Small molecule
Subject Vincristine Small molecule
Subject procarbazine Small molecule

Indications