Prospective Study on HIV-related Hodgkin Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
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

November 1, 2011
November 7, 2011
March 2004
February 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01468740 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-associated Hodgkin Lymphoma
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
July 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Marcus Hentrich, MD 0049 89 6210 2663 marcus.hentrich@klinikum-muenchen.de
Germany
 
NCT01468740
HIV-HL 2004
Not Provided
Harlachinger Krebshilfe e.V.
Harlachinger Krebshilfe e.V.
Deutsche AIDS Gesellschaft e.V.
Principal Investigator: Marcus Hentrich, MD Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care
Harlachinger Krebshilfe e.V.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP