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A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
HIV-associated Hodgkin Lymphoma

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Trial Information

A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

30 days after termination of chemotherapy or radiotherapy

Safety Issue:

Yes

Principal Investigator

Marcus Hentrich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care

Authority:

Germany: The Bavarian State Ministry of the Environment and Public Health

Study ID:

HIV-HL 2004

NCT ID:

NCT01468740

Start Date:

March 2004

Completion Date:

July 2012

Related Keywords:

  • HIV-associated Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma

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