Hodgkin LymphomaPhase 1/2HD-R3iNCT01453504
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma
A Phase 1/2 study testing DHAP and Everolimus in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of this trial is 1. to determine the recommended dose of everolimus for a subsequent Phase II trial 2. to determine the efficacy of everolimus plus DHAP Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- DHAP and Everolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Mar 2019
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- relapsed or refractory Hodgkin Lymphoma
- age 18-60
- histology confirmed relapse
Who cannot join
- previous therapy with mTOR inhibitor
- current CNS involvement
- other primary malignant disease within the last 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
The purpose of this trial is
- to determine the recommended dose of everolimus for a subsequent Phase II trial
- to determine the efficacy of everolimus plus DHAP
- Conditions
- Hodgkin Lymphoma
- Being tested
- DHAP, Everolimus
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHAPDrug
Dexamethasone, Cytarabine, Cisplatin
EverolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Ever-DHAP | Active comparator | Combination of Everolimus and DHAP Receives: Drug: DHAP; Drug: Everolimus |
| Placebo-DHAP | Placebo comparator | Not described Receives: Drug: DHAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity Rate (DLT)
Phase I primary outcome measure
Measured: 4 weeks
Complete Remission Rate (CR)
Phase II primary outcome measure
Measured: 4 weeks
Secondary outcomes (3)
Adverse event rate
Phase I secondary outcome measure
Measured: 4 weeks
Tumor status (assessed by CT) after chemotherapy
Phase II secondary outcome measure
Measured: 4 weeks
Tumor status (assessed by PET) after chemotherapy
Phase II secondary outcome measure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startAug 2012
- Primary completionMar 2019
- Study completionMar 2019
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Peter Borchmann, University of Cologne
- Investigators
- Peter Borchmann, Prof., Study chair, University of Cologne, German Hodgkin Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453504
- Sponsor's protocol ID
- HD-R3i
- Acronym
- HD-R3i
- Status last verified
- Nov 2019
- First submitted
- 17 Oct 2011
- Last updated
- 8 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
- ClinicalTrials.gov ID
- NCT01453504
- Acronym / sponsor ID
- HD-R3i / HD-R3i
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 18 Oct 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.
The purpose of this trial is
- to determine the recommended dose of everolimus for a subsequent Phase II trial
- to determine the efficacy of everolimus plus DHAP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ever-DHAP | Active comparator | Drug: DHAP, Drug: EverolimusCombination of Everolimus and DHAP |
| Placebo-DHAP | Placebo comparator | Drug: DHAP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- relapsed or refractory Hodgkin Lymphoma
- age 18-60
- histology confirmed relapse
Key exclusion criteria (3 listed)
- previous therapy with mTOR inhibitor
- current CNS involvement
- other primary malignant disease within the last 3 years
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 |
|---|---|---|
| DHAPDexamethasone, Cytarabine, Cisplatin | Drug | Ever-DHAP, Placebo-DHAP |
| Everolimus | Drug | Ever-DHAP |
Primary outcome
Dose Limiting Toxicity Rate (DLT)
Time frame: 4 weeks
Phase I primary outcome measure
Complete Remission Rate (CR)
Time frame: 4 weeks
Phase II primary outcome measure
3 secondary outcomes
Adverse event rate
Time frame: 4 weeks
Tumor status (assessed by CT) after chemotherapy
Time frame: 4 weeks
Tumor status (assessed by PET) after chemotherapy
Time frame: 4 weeks
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 8 Nov 2019.
- Homepage GHSGLink 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.
Peter Borchmann, Prof. study chair
University of Cologne, German Hodgkin Study Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DHAP and Everolimus 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 3 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 8 Nov 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
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 Toxicity Rate (DLT) (time frame: 4 weeks). 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 8 Nov 2019.