Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
130 participants
INTERVENTIONAL
2004-03-31
2012-07-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Doxorubicin
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.
Bleomycin
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.
Vinblastine
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
Dacarbazine
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
Etoposide
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.
Cyclophosphamide
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.
Vincristine
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.
Procarbazine
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.
Prednisone
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.
Eligibility Criteria
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Inclusion Criteria
* proven infection with HIV 1 (Elisa and Western Blot)
* histology-proven newly diagnosed Hodgkin lymphoma
* written, informed consent.
Exclusion Criteria
* severe renal insufficiency (creatinine \> 2,0 mg/dl) not caused by lymphoma
* bone marrow failure, not caused by lymphoma or HAART (neutrophils \< 1000/µl, platelets \< 70.000/µl)
* uncontrolled infection
* uncontrolled drug addiction or psychiatric disease
* pregnancy or lactation period
* prior chemotherapy of Hodgkin lymphoma
* life expectancy \< 6 weeks
* HIV-related wasting-syndrome
* active secondary malignancy with cervix carcinoma in situ, basalioma and Kaposi's sarcoma being excepted
18 Years
75 Years
ALL
No
Sponsors
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Deutsche AIDS Gesellschaft e.V.
UNKNOWN
Harlachinger Krebshilfe e.V.
OTHER
Responsible Party
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Principal Investigators
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Marcus Hentrich, MD
Role: PRINCIPAL_INVESTIGATOR
Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care
Locations
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Vivantes Auguste Victoria Klinikum
Berlin, , Germany
Ärzteforum Seestrasse
Berlin, , Germany
Universiy of Bonn
Bonn, , Germany
University of Cologne
Cologne, , Germany
University of Frankfurt
Frankfurt, , Germany
Asklepios Klinikum St. Georg
Hamburg, , Germany
Infektionsmedizinisches Zentrum Hamburg
Hamburg, , Germany
Harlaching Hospital
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HIV-HL 2004
Identifier Type: -
Identifier Source: org_study_id