NCT01468740

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

7.9 years

First QC Date

November 1, 2011

Last Update Submit

November 7, 2011

Conditions

HIV-associated Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Interventions

DoxorubicinDRUG

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.

BleomycinDRUG

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.

VinblastineDRUG

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

DacarbazineDRUG

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

EtoposideDRUG

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.

CyclophosphamideDRUG

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.

VincristineDRUG

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.

ProcarbazineDRUG

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.

PrednisoneDRUG

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 - 75 years
  • proven infection with HIV 1 (Elisa and Western Blot)
  • histology-proven newly diagnosed Hodgkin lymphoma
  • written, informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Vivantes Auguste Victoria Klinikum

Berlin, 12157, Germany

RECRUITING

Ärzteforum Seestrasse

Berlin, 13347, Germany

RECRUITING

Universiy of Bonn

Bonn, 53127, Germany

RECRUITING

University of Cologne

Cologne, 50924, Germany

RECRUITING

University of Frankfurt

Frankfurt, 60590, Germany

RECRUITING

Asklepios Klinikum St. Georg

Hamburg, 20099, Germany

RECRUITING

Infektionsmedizinisches Zentrum Hamburg

Hamburg, 20146, Germany

RECRUITING

Harlaching Hospital

Munich, 81545, Germany

RECRUITING

MeSH Terms

Interventions

DoxorubicinBleomycinVinblastineDacarbazineEtoposideCyclophosphamideVincristineProcarbazinePrednisone

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and ProteinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Marcus Hentrich, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Hentrich, MD

CONTACT

0049 89 6210 2663marcus.hentrich@klinikum-muenchen.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 9, 2011

Study Start

March 1, 2004

Primary Completion

February 1, 2012

Study Completion

July 1, 2012

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

DE(8)