Clinical trial NCT01468740: Prospective Study on HIV-related Hodgkin Lymphoma
Official title: A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV-associated Hodgkin Lymphoma
Lead sponsor: Harlachinger Krebshilfe e.V.
Sponsor class: OTHER
Collaborators: name: Deutsche AIDS Gesellschaft e.V.
First posted: 2011-11-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
timeFrame: 30 days after termination of chemotherapy or radiotherapy
measure: Treatment related mortality
timeFrame: 30 days after termination of chemotherapy or radiotherapy
Secondary outcomes:
measure: Overall Survival
timeFrame: 12 months and 24 months after termination of chemotherapy or radiotherapy
measure: Progression-free survival
timeFrame: 12 months and 24 months after termination of chemotherapy or radiotherapy
measure: Complete remission rate
timeFrame: 30 days and 90 days after termination of chemotherapy or radiotherapy
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Auguste Victoria Klinikum
city: Berlin
country: Germany
facility: Ärzteforum Seestrasse
city: Bonn
country: Germany
facility: Universiy of Bonn
city: Cologne
country: Germany
facility: University of Cologne
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Hamburg
country: Germany
facility: Asklepios Klinikum St. Georg
city: Hamburg
country: Germany
facility: Infektionsmedizinisches Zentrum Hamburg
city: Munich
country: Germany
facility: Harlaching Hospital
Study officials:
affiliation: Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care
name: Marcus Hentrich, MD
role: PRINCIPAL_INVESTIGATOR
References: