Hodgkin LymphomaPhase 1AVD-RevNCT01056679
Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients
A Phase 1 study testing Doxorubicine, DTIC and Lenalidomide in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Doxorubicine, DTIC and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Feb 2016
- Phase
- Phase 1
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hodgkin Lymphoma, intermediate or advanced stage
- Age >60 and <75 years
- ECOG 2 or better
- No major organ dysfunction
- Ability to take aspirin or LMW Heparin
Who cannot join
- HL as composite lymphoma
- Prior use of lenalidomide
- Prior use of chemo- or radiotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
1st Dept. of Medicine, Cologne University Hospital
Cologne, North Rhine-Westphalia, 50924
About this study
Official title: Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Doxorubicine, DTIC, Lenalidomide, Vinblastine
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicineDrug
50mg/m2 day 1 + 15
DTICDrug
375mg/m2 day 1 + 15
LenalidomideDrug
day 1 - 21
VinblastineDrug
6mg/m2 day 1 + 15
| Study group | Role | What they receive |
|---|---|---|
| AVD-Rev | Experimental | Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results Receives: Drug: Doxorubicine; Drug: DTIC; Drug: Lenalidomide; Drug: Vinblastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLT)
Secondary outcomes (2)
Overall response rate (ORR)
Progression free survival (PFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2014
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Engert, University of Cologne
- Investigators
- Andreas Engert, Prof., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056679
- Sponsor's protocol ID
- AVD-Rev
- Acronym
- AVD-Rev
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2009
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
- ClinicalTrials.gov ID
- NCT01056679
- Acronym / sponsor ID
- AVD-Rev / AVD-Rev
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Jan 2010 (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.
The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVD-Rev | Experimental | Drug: Doxorubicine, Drug: DTIC, Drug: Lenalidomide, Drug: VinblastinePatients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hodgkin Lymphoma, intermediate or advanced stage
- Age >60 and <75 years
- ECOG 2 or better
- No major organ dysfunction
- Ability to take aspirin or LMW Heparin
Key exclusion criteria (3 listed)
- HL as composite lymphoma
- Prior use of lenalidomide
- Prior use of chemo- or radiotherapy
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 |
|---|---|---|
| Doxorubicine50mg/m2 day 1 + 15 | Drug | AVD-Rev |
| DTIC375mg/m2 day 1 + 15 | Drug | AVD-Rev |
| Lenalidomideday 1 - 21 | Drug | AVD-Rev |
| Vinblastine6mg/m2 day 1 + 15 | Drug | AVD-Rev |
Primary outcome
Dose limiting toxicities (DLT)
2 secondary outcomes
Overall response rate (ORR)
Progression free survival (PFS)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Related InfoLink provided by the sponsor.
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Andreas Engert, Prof. principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxorubicine, DTIC and Lenalidomide in people with Hodgkin Lymphoma, run by University of Cologne at 1 site 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (DLT). 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 22 Mar 2018.