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Prospective Study on HIV-related Hodgkin Lymphoma

Primary Purpose

HIV-associated Hodgkin Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Doxorubicin
Bleomycin
Vinblastine
Dacarbazine
Etoposide
Cyclophosphamide
Vincristine
Procarbazine
Prednisone
Sponsored by
Harlachinger Krebshilfe e.V.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-associated Hodgkin Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vivantes Auguste Victoria KlinikumRecruiting
  • Ärzteforum SeestrasseRecruiting
  • Universiy of BonnRecruiting
  • University of CologneRecruiting
  • University of FrankfurtRecruiting
  • Asklepios Klinikum St. GeorgRecruiting
  • Infektionsmedizinisches Zentrum HamburgRecruiting
  • Harlaching HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival
Progression-free survival
Complete remission rate

Full Information

First Posted
November 1, 2011
Last Updated
November 7, 2011
Sponsor
Harlachinger Krebshilfe e.V.
Collaborators
Deutsche AIDS Gesellschaft e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01468740
Brief Title
Prospective Study on HIV-related Hodgkin Lymphoma
Official Title
A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harlachinger Krebshilfe e.V.
Collaborators
Deutsche AIDS Gesellschaft e.V.

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-associated Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Procarbazine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
Time Frame
30 days after termination of chemotherapy or radiotherapy
Title
Treatment related mortality
Time Frame
30 days after termination of chemotherapy or radiotherapy
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
12 months and 24 months after termination of chemotherapy or radiotherapy
Title
Progression-free survival
Time Frame
12 months and 24 months after termination of chemotherapy or radiotherapy
Title
Complete remission rate
Time Frame
30 days and 90 days after termination of chemotherapy or radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Hentrich, MD
Phone
0049 89 6210 2663
Email
marcus.hentrich@klinikum-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Hentrich, MD
Organizational Affiliation
Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vivantes Auguste Victoria Klinikum
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Müller, MD
Phone
0049 30 130 20 2321
Email
Markus.Mueller2@vivantes.de
First Name & Middle Initial & Last Name & Degree
Marcel Berger, MD
Phone
0049 30 130 20 2321
Email
Marcel.Berger@vivantes.de
First Name & Middle Initial & Last Name & Degree
Markus Müller, MD
First Name & Middle Initial & Last Name & Degree
Marcel Berger, MD
First Name & Middle Initial & Last Name & Degree
Keikawus Arasteh, MD
Facility Name
Ärzteforum Seestrasse
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Siehl, MD
Phone
0049 30 455095-0
Email
jan.siehl@aerzteforum-seestrasse.de
First Name & Middle Initial & Last Name & Degree
Jan Siehl, MD
Facility Name
Universiy of Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juergen Rockstroh, MD
Phone
0049 228 287 16558
Email
Rockstroh@uni-bonn.de;
First Name & Middle Initial & Last Name & Degree
Jürgen Rockstroh, MD
Facility Name
University of Cologne
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Wyen, MD
Phone
0049 221 478 88835
Email
christoph.wyen@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Gerd Fätkenheuer, MD
Phone
0049 221 478 4886
Email
g.faetkenheuer@uni-koeln.de
First Name & Middle Initial & Last Name & Degree
Christoph Wyen, MD
First Name & Middle Initial & Last Name & Degree
Gerd Fätkenheuer, MD
Facility Name
University of Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timo Wolf, MD
Phone
0049 69 6301 5452
Email
Timo.Wolf@kgu.de
First Name & Middle Initial & Last Name & Degree
Timo Wolf, MD
Facility Name
Asklepios Klinikum St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maike Nickelsen, MD
Phone
0049 40 18 18 85 20 05
Email
m.nickelsen@asklepios.com
First Name & Middle Initial & Last Name & Degree
Maike Nickelsen, MD
Facility Name
Infektionsmedizinisches Zentrum Hamburg
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Hoffmann, MD
Phone
0049 40 4132420
Email
hoffmann@ich-hamburg.de;
First Name & Middle Initial & Last Name & Degree
Christian Hoffmann, MD
Facility Name
Harlaching Hospital
City
Munich
ZIP/Postal Code
81545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Hentrich, MD
Phone
0049 89 6210 2663 or 2731
Email
marcus.hentrich@klinikum-muenchen.de
First Name & Middle Initial & Last Name & Degree
Marcus Hentrich, MD

12. IPD Sharing Statement

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Prospective Study on HIV-related Hodgkin Lymphoma

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