Prospective Study on HIV-related Hodgkin Lymphoma

A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma

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 Overview

• Status: Unknown
• Conditions: HIV-associated Hodgkin Lymphoma
• Intervention / Treatment: Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Procarbazine; Drug: Prednisone

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marcus Hentrich, MD; Phone Number: 0049 89 6210 2663; Email: marcus.hentrich@klinikum-muenchen.de

Study Locations

• Germany
  • Berlin, Germany, 12157
    • Recruiting
    • Vivantes Auguste Victoria Klinikum
    • Contact: Markus Müller, MD; Phone Number: 0049 30 130 20 2321; Email: Markus.Mueller2@vivantes.de
    • Contact: Marcel Berger, MD; Phone Number: 0049 30 130 20 2321; Email: Marcel.Berger@vivantes.de
    • Sub-Investigator: Markus Müller, MD
    • Sub-Investigator: Marcel Berger, MD
    • Principal Investigator: Keikawus Arasteh, MD
  • Berlin, Germany, 13347
    • Recruiting
    • Ärzteforum Seestrasse
    • Contact: Jan Siehl, MD; Phone Number: 0049 30 455095-0; Email: jan.siehl@aerzteforum-seestrasse.de
    • Principal Investigator: Jan Siehl, MD
  • Bonn, Germany, 53127
    • Recruiting
    • Universiy of Bonn
    • Contact: Juergen Rockstroh, MD; Phone Number: 0049 228 287 16558; Email: Rockstroh@uni-bonn.de;
    • Principal Investigator: Jürgen Rockstroh, MD
  • Cologne, Germany, 50924
    • Recruiting
    • University of Cologne
    • Principal Investigator: Gerd Fatkenheuer, MD
    • Contact: Christoph Wyen, MD; Phone Number: 0049 221 478 88835; Email: christoph.wyen@uk-koeln.de
    • Contact: Gerd Fätkenheuer, MD; Phone Number: 0049 221 478 4886; Email: g.faetkenheuer@uni-koeln.de
    • Sub-Investigator: Christoph Wyen, MD
  • Frankfurt, Germany, 60590
    • Recruiting
    • University of Frankfurt
    • Contact: Timo Wolf, MD; Phone Number: 0049 69 6301 5452; Email: Timo.Wolf@kgu.de
    • Principal Investigator: Timo Wolf, MD
  • Hamburg, Germany, 20099
    • Recruiting
    • Asklepios Klinikum St. Georg
    • Contact: Maike Nickelsen, MD; Phone Number: 0049 40 18 18 85 20 05; Email: m.nickelsen@asklepios.com
    • Principal Investigator: Maike Nickelsen, MD
  • Hamburg, Germany, 20146
    • Recruiting
    • Infektionsmedizinisches Zentrum Hamburg
    • Contact: Christian Hoffmann, MD; Phone Number: 0049 40 4132420; Email: hoffmann@ich-hamburg.de;
    • Principal Investigator: Christian Hoffmann, MD
  • Munich, Germany, 81545
    • Recruiting
    • Harlaching Hospital
    • Contact: Marcus Hentrich, MD; Phone Number: 0049 89 6210 2663 or 2731; Email: marcus.hentrich@klinikum-muenchen.de
    • Principal Investigator: Marcus Hentrich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity	30 days after termination of chemotherapy or radiotherapy
Treatment related mortality	30 days after termination of chemotherapy or radiotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	12 months and 24 months after termination of chemotherapy or radiotherapy
Progression-free survival	12 months and 24 months after termination of chemotherapy or radiotherapy
Complete remission rate	30 days and 90 days after termination of chemotherapy or radiotherapy

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2011
• Last Update Submitted That Met QC Criteria: November 7, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Etoposide; Prednisone; Doxorubicin; Vincristine; Dacarbazine; Bleomycin; Vinblastine; Procarbazine
• Other Study ID Numbers: HIV-HL 2004