Prospective Study on HIV-related Hodgkin Lymphoma
Overview[ - collapse ][ - ]
Purpose | 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). |
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Condition | HIV-associated Hodgkin Lymphoma |
Intervention | Drug: Doxorubicin Drug: Bleomycin Drug: Vinblastine Drug: Dacarbazine Drug: Etoposide Drug: Cyclophosphamide Drug: Vincristine Drug: Procarbazine Drug: Prednisone |
Phase | Phase 2 |
Sponsor | Harlachinger Krebshilfe e.V. |
Responsible Party | Harlachinger Krebshilfe e.V. |
ClinicalTrials.gov Identifier | NCT01468740 |
First Received | November 1, 2011 |
Last Updated | November 7, 2011 |
Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | November 1, 2011 |
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Last Updated Date | November 7, 2011 |
Start Date | March 2004 |
Estimated Primary Completion Date | July 2012 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Prospective Study on HIV-related Hodgkin Lymphoma |
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Official Title | A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma |
Brief 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). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | HIV-associated Hodgkin Lymphoma |
Intervention | Drug: 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. Drug: 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. Drug: 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 Drug: 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 Drug: 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. Drug: 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. Drug: 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. Drug: 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. Drug: 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. |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 130 |
Estimated Completion Date | July 2012 |
Estimated Primary Completion Date | February 2012 |
Eligibility Criteria | Inclusion Criteria: - age 18 - 75 years - proven infection with HIV 1 (Elisa and Western Blot) - histology-proven newly diagnosed Hodgkin lymphoma - written, informed consent. Exclusion Criteria: - severe cardiac, hepatic or pulmonary insufficiency - 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Marcus Hentrich, MD 0049 89 6210 2663 marcus.hentrich@klinikum-muenchen.de |
Location Countries | Germany |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01468740 |
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Other Study ID Numbers | HIV-HL 2004 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Harlachinger Krebshilfe e.V. |
Study Sponsor | Harlachinger Krebshilfe e.V. |
Collaborators | Deutsche AIDS Gesellschaft e.V. |
Investigators | Principal Investigator: Marcus Hentrich, MD Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care |
Verification Date | November 2011 |
Locations[ + expand ][ + ]
Ärzteforum Seestrasse | Berlin, Germany, 13347 Contact: Jan Siehl, MD | 0049 30 455095-0 | jan.siehl@aerzteforum-seestrasse.dePrincipal Investigator: Jan Siehl, MD Recruiting |
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Vivantes Auguste Victoria Klinikum | Berlin, Germany, 12157 Contact: Markus Müller, MD | 0049 30 130 20 2321 | Markus.Mueller2@vivantes.deSub-Investigator: Markus Müller, MD Recruiting |
Universiy of Bonn | Bonn, Germany, 53127 Contact: Juergen Rockstroh, MD | 0049 228 287 16558 | Rockstroh@uni-bonn.de;Principal Investigator: Jürgen Rockstroh, MD Recruiting |
University of Cologne | Cologne, Germany, 50924 Contact: Christoph Wyen, MD | 0049 221 478 88835 | christoph.wyen@uk-koeln.deSub-Investigator: Christoph Wyen, MD Recruiting |
University of Frankfurt | Frankfurt, Germany, 60590 Contact: Timo Wolf, MD | 0049 69 6301 5452 | Timo.Wolf@kgu.dePrincipal Investigator: Timo Wolf, MD Recruiting |
Asklepios Klinikum St. Georg | Hamburg, Germany, 20099 Contact: Maike Nickelsen, MD | 0049 40 18 18 85 20 05 | m.nickelsen@asklepios.comPrincipal Investigator: Maike Nickelsen, MD Recruiting |
Infektionsmedizinisches Zentrum Hamburg | Hamburg, Germany, 20146 Contact: Christian Hoffmann, MD | 0049 40 4132420 | hoffmann@ich-hamburg.de;Principal Investigator: Christian Hoffmann, MD Recruiting |
Harlaching Hospital | Munich, Germany, 81545 Contact: Marcus Hentrich, MD | 0049 89 6210 2663 or 2731 | marcus.hentrich@klinikum-muenchen.dePrincipal Investigator: Marcus Hentrich, MD Recruiting |