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Prospective Study on HIV-related Hodgkin Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Harlachinger Krebshilfe e.V..
Recruitment status was:  Recruiting
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
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468740

Locations
Germany
Vivantes Auguste Victoria Klinikum
Berlin, Germany, 12157
Ärzteforum Seestrasse
Berlin, Germany, 13347
Universiy of Bonn
Bonn, Germany, 53127
University of Cologne
Cologne, Germany, 50924
University of Frankfurt
Frankfurt, Germany, 60590
Asklepios Klinikum St. Georg
Hamburg, Germany, 20099
Infektionsmedizinisches Zentrum Hamburg
Hamburg, Germany, 20146
Harlaching Hospital
Munich, Germany, 81545
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

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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Liposomal doxorubicin
Etoposide phosphate
Doxorubicin
Prednisone
Etoposide
Vincristine
Bleomycin
Procarbazine
Vinblastine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016