HIV-associated Hodgkin LymphomaPhase 2NCT01468740
Prospective Study on HIV-related Hodgkin Lymphoma
A Phase 2 study testing Doxorubicin, Bleomycin and Vinblastine in people with HIV-associated Hodgkin Lymphoma, run by Harlachinger Krebshilfe e.V. at 8 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV-associated Hodgkin Lymphoma
- What is being tested?
- Doxorubicin, Bleomycin and Vinblastine
- How many people
- 130 participants
- Where
- 8 sitesGermany
- Study dates
- Mar 2004to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 - 75 years
- proven infection with HIV 1 (Elisa and Western Blot)
- histology-proven newly diagnosed Hodgkin lymphoma
- written, informed consent.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites, 8 recruiting
- Recruiting
Vivantes Auguste Victoria Klinikum
Berlin, 12157
Markus Müller, MD, 0049 30 130 20 2321, Markus.Mueller2@vivantes.de
Marcel Berger, MD, 0049 30 130 20 2321, Marcel.Berger@vivantes.de
- Recruiting
Ärzteforum Seestrasse
Berlin, 13347
Jan Siehl, MD, 0049 30 455095-0, jan.siehl@aerzteforum-seestrasse.de
Jan Siehl, MD
- Recruiting
Universiy of Bonn
Bonn, 53127
Juergen Rockstroh, MD, 0049 228 287 16558, Rockstroh@uni-bonn.de;
Jürgen Rockstroh, MD
- Recruiting
University of Cologne
Cologne, 50924
Christoph Wyen, MD, 0049 221 478 88835, christoph.wyen@uk-koeln.de
Gerd Fätkenheuer, MD, 0049 221 478 4886, g.faetkenheuer@uni-koeln.de
- Recruiting
University of Frankfurt
Frankfurt, 60590
Timo Wolf, MD, 0049 69 6301 5452, Timo.Wolf@kgu.de
Timo Wolf, MD
- Recruiting
Asklepios Klinikum St. Georg
Hamburg, 20099
Maike Nickelsen, MD, 0049 40 18 18 85 20 05, m.nickelsen@asklepios.com
Maike Nickelsen, MD
- Recruiting
Infektionsmedizinisches Zentrum Hamburg
Hamburg, 20146
Christian Hoffmann, MD, 0049 40 4132420, hoffmann@ich-hamburg.de;
Christian Hoffmann, MD
- Recruiting
Harlaching Hospital
Munich, 81545
Marcus Hentrich, MD, 0049 89 6210 2663 or 2731, marcus.hentrich@klinikum-muenchen.de
Marcus Hentrich, MD
About this study
Official title: A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma
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).
- Conditions
- HIV-associated Hodgkin Lymphoma
- Being tested
- Doxorubicin, Bleomycin, Vinblastine, Dacarbazine, Etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
Measured: 30 days after termination of chemotherapy or radiotherapy
Treatment related mortality
Measured: 30 days after termination of chemotherapy or radiotherapy
Secondary outcomes (3)
Overall Survival
Measured: 12 months and 24 months after termination of chemotherapy or radiotherapy
Progression-free survival
Measured: 12 months and 24 months after termination of chemotherapy or radiotherapy
Complete remission rate
Measured: 30 days and 90 days after termination of chemotherapy or radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startMar 2004
- Primary completionFeb 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-associated Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harlachinger Krebshilfe e.V.
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche AIDS Gesellschaft e.V.
- Responsible party
- Sponsor
- Investigators
- Marcus Hentrich, MD, Principal investigator, Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468740
- Sponsor's protocol ID
- HIV-HL 2004
- Status last verified
- Nov 2011
- First submitted
- 1 Nov 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01468740
- Acronym / sponsor ID
- HIV-HL 2004
- Conditions
- HIV-associated Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Harlachinger Krebshilfe e.V.University, hospital or other
- Collaborators
- Deutsche AIDS Gesellschaft e.V.
- Study start
- Mar 2004
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 - 75 years
- proven infection with HIV 1 (Elisa and Western Blot)
- histology-proven newly diagnosed Hodgkin lymphoma
- written, informed consent.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinThe 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. | Drug | – |
| BleomycinThe 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. | Drug | – |
| VinblastineThe 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 | Drug | – |
| DacarbazineThe 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 | Drug | – |
| EtoposideThe 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. | Drug | – |
| CyclophosphamideThe 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. | Drug | – |
| VincristineThe 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. | Drug | – |
| ProcarbazineThe 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. | Drug | – |
| PrednisoneThe 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. | Drug | – |
Primary outcome
Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
Time frame: 30 days after termination of chemotherapy or radiotherapy
Treatment related mortality
Time frame: 30 days after termination of chemotherapy or radiotherapy
3 secondary outcomes
Overall Survival
Time frame: 12 months and 24 months after termination of chemotherapy or radiotherapy
Progression-free survival
Time frame: 12 months and 24 months after termination of chemotherapy or radiotherapy
Complete remission rate
Time frame: 30 days and 90 days after termination of chemotherapy or radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
Related trials for HIV-associated Hodgkin Lymphoma
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingObservational study
Natural History of KSHV-Associated Multicentric Castleman s Disease
Multicentric Castleman s Disease
RecruitingPhase 1/2
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
B-Cell Non-Hodgkin's Lymphoma (NHL), Lymphoma, Non-Hodgkins
Recruiting
New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
RecruitingPhase 1
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
Diffuse Large Cell Lymphoma, Non-Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Hentrich, MD principal investigator
Harlaching Hospital, Academic Teaching Hospital of the University of Munich, Department of Hematology, Oncology and Palliative Care
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxorubicin, Bleomycin and Vinblastine in people with HIV-associated Hodgkin Lymphoma, run by Harlachinger Krebshilfe e.V. at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Hentrich, MD (0049 89 6210 2663, marcus.hentrich@klinikum-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity (time frame: 30 days after termination of chemotherapy or radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011.