Prospective Study on HIV-related Hodgkin Lymphoma

Sponsor

Harlachinger Krebshilfe e.V. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01468740

Collaborator

Deutsche AIDS Gesellschaft e.V. (Other)

130

Enrollment

Locations

100

Duration (Months)

16.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma

Study Start Date :

Mar 1, 2004

Anticipated Primary Completion Date :

Feb 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Vivantes Auguste Victoria Klinikum	Berlin	Germany	12157
2	Ärzteforum Seestrasse	Berlin	Germany	13347
3	Universiy of Bonn	Bonn	Germany	53127
4	University of Cologne	Cologne	Germany	50924
5	University of Frankfurt	Frankfurt	Germany	60590
6	Asklepios Klinikum St. Georg	Hamburg	Germany	20099
7	Infektionsmedizinisches Zentrum Hamburg	Hamburg	Germany	20146
8	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