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Prospective Study on HIV-related Hodgkin Lymphoma

This study is currently recruiting participants.
Verified November 2011 by Harlachinger Krebshilfe e.V.
Sponsor:
Collaborator:
Deutsche AIDS Gesellschaft e.V.
Information provided by (Responsible Party):
Harlachinger Krebshilfe e.V.
ClinicalTrials.gov Identifier:
NCT01468740
First received: November 1, 2011
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  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).

Condition Intervention Phase
HIV-associated Hodgkin Lymphoma
 Drug: Doxorubicin
Drug: Bleomycin
Drug: Vinblastine
Drug: Dacarbazine
Drug: Etoposide
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Procarbazine
Drug: Prednisone
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harlachinger Krebshilfe e.V.:

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 ]

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 ]

Estimated Enrollment: 130
Study Start Date: March 2004
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468740

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

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

No publications provided

Responsible Party: Harlachinger Krebshilfe e.V.
ClinicalTrials.gov Identifier: NCT01468740     History of Changes
Other Study ID Numbers: HIV-HL 2004
Study First Received: November 1, 2011
Last Updated: November 7, 2011
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Etoposide phosphate
Cyclophosphamide
Dacarbazine
Etoposide
Prednisone
 Procarbazine
Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on June 18, 2013