Prospective Study on HIV-related Hodgkin Lymphoma

HIV-associated Hodgkin Lymphoma Clinical Trial

Official title:

A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01468740
• Other study ID #: HIV-HL 2004
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 2011
• Last updated: November 7, 2011
• Start date: March 2004
• Est. completion date: July 2012

Study information

• Verified date: November 2011
• Source: Harlachinger Krebshilfe e.V.
• Contact: Marcus Hentrich, MD
• Phone: 0049 89 6210 2663
• Email: marcus.hentrich[@]klinikum-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV-associated Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

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.
• 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.
• 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
• 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
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Ärzteforum Seestrasse	Berlin
Germany	Vivantes Auguste Victoria Klinikum	Berlin
Germany	Universiy of Bonn	Bonn
Germany	University of Cologne	Cologne
Germany	University of Frankfurt	Frankfurt
Germany	Asklepios Klinikum St. Georg	Hamburg
Germany	Infektionsmedizinisches Zentrum Hamburg	Hamburg
Germany	Harlaching Hospital	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Harlachinger Krebshilfe e.V.	Deutsche AIDS Gesellschaft e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity		30 days after termination of chemotherapy or radiotherapy	Yes
Primary	Treatment related mortality		30 days after termination of chemotherapy or radiotherapy	Yes
Secondary	Overall Survival		12 months and 24 months after termination of chemotherapy or radiotherapy	No
Secondary	Progression-free survival		12 months and 24 months after termination of chemotherapy or radiotherapy	No
Secondary	Complete remission rate		30 days and 90 days after termination of chemotherapy or radiotherapy	No