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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
The four-drug ABVD chemotherapy regimen and the seven-drug BEACOPP-baseline chemotherapy regimen contain doxorubicin. * Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation or 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation * Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. 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.
The four-drug ABVD chemotherapy regimen and the seven-drug BEACOPP-baseline chemotherapy regimen contain bleomycin. * Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation or 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation * Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. 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.
The four-drug ABVD chemotherapy regimen contains vinblastine * Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation
The four-drug ABVD chemotherapy regimen contains dacarbazine * Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation
The seven-drug BEACOPP-baseline chemotherapy regimen contains etoposide. * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation * Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. 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.
The seven-drug BEACOPP-baseline chemotherapy regimen contains cyclophosphamide. * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation * Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. 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.
The seven-drug BEACOPP-baseline chemotherapy regimen contains vincristine. * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation * Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. 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.
The seven-drug BEACOPP-baseline chemotherapy regimen contains procarbazine. * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation * Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. 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.
The seven-drug BEACOPP-baseline chemotherapy regimen contains prednisone. * Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation * Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. 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.
Vivantes Auguste Victoria Klinikum
Berlin, Germany
RECRUITINGÄrzteforum Seestrasse
Berlin, Germany
RECRUITINGUniversiy of Bonn
Bonn, Germany
RECRUITINGUniversity of Cologne
Cologne, Germany
RECRUITINGUniversity of Frankfurt
Frankfurt, Germany
RECRUITINGAsklepios Klinikum St. Georg
Hamburg, Germany
RECRUITINGInfektionsmedizinisches Zentrum Hamburg
Hamburg, Germany
RECRUITINGHarlaching Hospital
Munich, Germany
RECRUITINGNumber of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
Time frame: 30 days after termination of chemotherapy or radiotherapy
Treatment related mortality
Time frame: 30 days after termination of chemotherapy or radiotherapy
Overall Survival
Time frame: 12 months and 24 months after termination of chemotherapy or radiotherapy
Progression-free survival
Time frame: 12 months and 24 months after termination of chemotherapy or radiotherapy
Complete remission rate
Time frame: 30 days and 90 days after termination of chemotherapy or radiotherapy
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