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).
ConditionHIV-associated Hodgkin Lymphoma
InterventionDrug: Doxorubicin
Drug: Bleomycin
Drug: Vinblastine
Drug: Dacarbazine
Drug: Etoposide
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Procarbazine
Drug: Prednisone
PhasePhase 2
SponsorHarlachinger Krebshilfe e.V.
Responsible PartyHarlachinger Krebshilfe e.V.
ClinicalTrials.gov IdentifierNCT01468740
First ReceivedNovember 1, 2011
Last UpdatedNovember 7, 2011
Last verifiedNovember 2011

Tracking Information[ + expand ][ + ]

First Received DateNovember 1, 2011
Last Updated DateNovember 7, 2011
Start DateMarch 2004
Estimated Primary Completion DateJuly 2012
Current Primary Outcome Measures
  • Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity [Time Frame: 30 days after termination of chemotherapy or radiotherapy] [Designated as safety issue: Yes]
  • Treatment related mortality [Time Frame: 30 days after termination of chemotherapy or radiotherapy] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • Overall Survival [Time Frame: 12 months and 24 months after termination of chemotherapy or radiotherapy] [Designated as safety issue: No]
  • Progression-free survival [Time Frame: 12 months and 24 months after termination of chemotherapy or radiotherapy] [Designated as safety issue: No]
  • Complete remission rate [Time Frame: 30 days and 90 days after termination of chemotherapy or radiotherapy] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleProspective Study on HIV-related Hodgkin Lymphoma
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHIV-associated Hodgkin Lymphoma
InterventionDrug: 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 StatusRecruiting
Estimated Enrollment130
Estimated Completion DateJuly 2012
Estimated Primary Completion DateFebruary 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Marcus Hentrich, MD
0049 89 6210 2663
marcus.hentrich@klinikum-muenchen.de
Location CountriesGermany

Administrative Information[ + expand ][ + ]

NCT Number NCT01468740
Other Study ID NumbersHIV-HL 2004
Has Data Monitoring CommitteeNot Provided
Information Provided ByHarlachinger Krebshilfe e.V.
Study SponsorHarlachinger Krebshilfe e.V.
CollaboratorsDeutsche 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 DateNovember 2011

Locations[ + expand ][ + ]

Ärzteforum Seestrasse
Berlin, Germany, 13347
Contact: Jan Siehl, MD | 0049 30 455095-0 | jan.siehl@aerzteforum-seestrasse.de
Principal Investigator: Jan Siehl, MD
Recruiting
Vivantes Auguste Victoria Klinikum
Berlin, Germany, 12157
Contact: Markus Müller, MD | 0049 30 130 20 2321 | Markus.Mueller2@vivantes.de
Sub-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.de
Sub-Investigator: Christoph Wyen, MD
Recruiting
University of Frankfurt
Frankfurt, Germany, 60590
Contact: Timo Wolf, MD | 0049 69 6301 5452 | Timo.Wolf@kgu.de
Principal 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.com
Principal 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.de
Principal Investigator: Marcus Hentrich, MD
Recruiting