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Prospective Study on HIV-related Hodgkin Lymphoma

Information source: Harlachinger Krebshilfe e.V.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-associated Hodgkin Lymphoma

Intervention: Doxorubicin (Drug); Bleomycin (Drug); Vinblastine (Drug); Dacarbazine (Drug); Etoposide (Drug); Cyclophosphamide (Drug); Vincristine (Drug); Procarbazine (Drug); Prednisone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Harlachinger Krebshilfe e.V.

Official(s) and/or principal investigator(s):
Marcus Hentrich, MD, Principal Investigator, Affiliation: Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care

Overall contact:
Marcus Hentrich, MD, Phone: 0049 89 6210 2663, Email: marcus.hentrich@klinikum-muenchen.de

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).

Clinical Details

Official title: A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity

Treatment related mortality

Secondary outcome:

Overall Survival

Progression-free survival

Complete remission rate

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Marcus Hentrich, MD, Phone: 0049 89 6210 2663, Email: marcus.hentrich@klinikum-muenchen.de

Vivantes Auguste Victoria Klinikum, Berlin 12157, Germany; Recruiting
Markus Müller, MD, Phone: 0049 30 130 20 2321, Email: Markus.Mueller2@vivantes.de
Marcel Berger, MD, Phone: 0049 30 130 20 2321, Email: Marcel.Berger@vivantes.de
Markus Müller, MD, Sub-Investigator
Marcel Berger, MD, Sub-Investigator
Keikawus Arasteh, MD, Principal Investigator

Ärzteforum Seestrasse, Berlin 13347, Germany; Recruiting
Jan Siehl, MD, Phone: 0049 30 455095-0, Email: jan.siehl@aerzteforum-seestrasse.de
Jan Siehl, MD, Principal Investigator

Universiy of Bonn, Bonn 53127, Germany; Recruiting
Juergen Rockstroh, MD, Phone: 0049 228 287 16558, Email: Rockstroh@uni-bonn.de;
Jürgen Rockstroh, MD, Principal Investigator

University of Cologne, Cologne 50924, Germany; Recruiting
Christoph Wyen, MD, Phone: 0049 221 478 88835, Email: christoph.wyen@uk-koeln.de
Gerd Fätkenheuer, MD, Phone: 0049 221 478 4886, Email: g.faetkenheuer@uni-koeln.de
Christoph Wyen, MD, Sub-Investigator
Gerd Fätkenheuer, MD, Principal Investigator

University of Frankfurt, Frankfurt 60590, Germany; Recruiting
Timo Wolf, MD, Phone: 0049 69 6301 5452, Email: Timo.Wolf@kgu.de
Timo Wolf, MD, Principal Investigator

Asklepios Klinikum St. Georg, Hamburg 20099, Germany; Recruiting
Maike Nickelsen, MD, Phone: 0049 40 18 18 85 20 05, Email: m.nickelsen@asklepios.com
Maike Nickelsen, MD, Principal Investigator

Infektionsmedizinisches Zentrum Hamburg, Hamburg 20146, Germany; Recruiting
Christian Hoffmann, MD, Phone: 0049 40 4132420, Email: hoffmann@ich-hamburg.de;
Christian Hoffmann, MD, Principal Investigator

Harlaching Hospital, Munich 81545, Germany; Recruiting
Marcus Hentrich, MD, Phone: 0049 89 6210 2663 or 2731, Email: marcus.hentrich@klinikum-muenchen.de
Marcus Hentrich, MD, Principal Investigator

Additional Information

Starting date: March 2004
Last updated: November 7, 2011

Page last updated: August 23, 2015

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