Hodgkin DiseasePhase 2NCT01195766
Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma
A Phase 2 study testing Ofatumumab in people with Hodgkin Disease, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 14 sites in Spain.
Trial summary
The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- Ofatumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 14 sitesSpain
- Study dates
- Jul 2010to May 2015
- 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
- Patients with histologically confirmed relapsed, partial response or refractory classical HL after first line chemotherapy. They will be included irrespective of CD20 expression on HRS cells. CD20 expression will be analyzed on all available biopsies and this data will be recorded for further evaluation.
- Age 18 to 65 years. Patient >65 and <70 years old with ECOG < 2 and absence of comorbidities will be included in the study if considered adequate by the investigator.
- Leucocytes > 3,0 x 109/L and platelets > 100 x 109/L.
- ECOG < 2.
- No major organ dysfunction.
- Written informed consent.
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- HIV negative.
- No active hepatitis B or C infection.
- Availability of histological report of biopsy at diagnosis or at relapse and availability of biopsy to be revised by reference pathologists.
- Absence of other neoplasia, except basocellular tumor or carcinoma of the uterine cervix in situ.
- Contraception measures in fertile females.
Who cannot join
- Subjects who have current active hepatic or biliary disease
- presence of pathology that would contraindicate the administration of chemotherapy
- HIV positive
- Hepatitis B or C infection
- history of other malignancies in addition to those specified in the inclusion criteria
- informed consent not signed
- Pregnant and / or breast-feeding or reproductive capacity adults who do not use an effective method of birth control during study treatment and at least six months later. An effective method is that used at least one barrier mechanism.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Sant Pau
Barcelona, Barcelona, 08025
Hospital Clinic
Barcelona, Barcelona, 08036
Instituto Catalan de Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Hospital Ramon y Cajal
Madrid, Madrid
Hospital Carlos Haya
Málaga, Malaga, 29010
Hospital Morales Messeguer
Murcia, Murcia, 30008
Hospital Son Espases
Palma de Mallorca, Mallorca, 07010
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital Clinico de Salamanca
Salamanca, Salamanca, 37007
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, 38320
Hospital Clinico de Valencia
Valencia, Valencia, 46010
Hospital Rio Hortega
Valladolid, Valladolid, 47012
About this study
Official title: Phase II-study Using Ofatumumab and ESHAP Followed by Autologous Trasplant of Hemopoietic Precursors for the Treatment of Classic Hodgkin's Lymphoma on Relapse, Partial Response or Refractory to First Line Treatment
The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed.
In the same way, mortality, global survival and free-progression survival after O-ESHAP treatment and TAPH will also analyzed.
Read the detailed description
In addition to the above:
- To asses the complete response rate after O-ESHAP.
- To asses the toxicity of O-ESHAP regimen
- To asses the stem cells mobilization capacity of O-ESHAP regimen
- To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and progression free survival (PFS)
- To investigate the correlation between the overall response and CD20 expression by tumoral cells.
- Conditions
- Hodgkin Disease
- Being tested
- Ofatumumab
- Keywords
- Hodgkin, Ofatumumab, Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
Also called ARZERRA
Ofatumumab in addition with ESHAP therapy
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Experimental | Ofatumumab in addition to ESHAP therapy Receives: Drug: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment
Measured: 4 years follow-up
Secondary outcomes (1)
To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary
Measured: 4 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Martínez, MD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195766
- Sponsor's protocol ID
- O-ESHAP-LH-2009
- Other IDs
- 2009-016026-13, 2009
- Status last verified
- Feb 2016
- First submitted
- 3 Sep 2010
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II-study Using Ofatumumab and ESHAP Followed by Autologous Trasplant of Hemopoietic Precursors for the Treatment of Classic Hodgkin's Lymphoma on Relapse, Partial Response or Refractory to First Line Treatment
- ClinicalTrials.gov ID
- NCT01195766
- Acronym / sponsor ID
- O-ESHAP-LH-2009
- Conditions
- Hodgkin Disease
- Keywords
- Hodgkin, Ofatumumab, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Sep 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 aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed.
In the same way, mortality, global survival and free-progression survival after O-ESHAP treatment and TAPH will also analyzed.
Detailed description
In addition to the above:
- To asses the complete response rate after O-ESHAP.
- To asses the toxicity of O-ESHAP regimen
- To asses the stem cells mobilization capacity of O-ESHAP regimen
- To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and progression free survival (PFS)
- To investigate the correlation between the overall response and CD20 expression by tumoral cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | Experimental | Drug: OfatumumabOfatumumab in addition to ESHAP therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically confirmed relapsed, partial response or refractory classical HL after first line chemotherapy. They will be included irrespective of CD20 expression on HRS cells. CD20 expression will be analyzed on all available biopsies and this data will be recorded for further evaluation.
- Age 18 to 65 years. Patient >65 and <70 years old with ECOG < 2 and absence of comorbidities will be included in the study if considered adequate by the investigator.
- Leucocytes > 3,0 x 109/L and platelets > 100 x 109/L.
- ECOG < 2.
- No major organ dysfunction.
Key exclusion criteria (7 listed)
- Subjects who have current active hepatic or biliary disease
- presence of pathology that would contraindicate the administration of chemotherapy
- HIV positive
- Hepatitis B or C infection
- history of other malignancies in addition to those specified in the inclusion criteria
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 |
|---|---|---|
| OfatumumabAlso: ARZERRAOfatumumab in addition with ESHAP therapy | Drug | Ofatumumab |
Primary outcome
Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment
Time frame: 4 years follow-up
1 secondary outcome
To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary
Time frame: 4 years follow-up
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 24 Feb 2016.
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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.
Carmen Martínez, MD study director
Hospital Clinic of Barcelona
14 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 Ofatumumab in people with Hodgkin Disease, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 14 sites in Spain.
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 11 inclusion and 7 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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?
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?
Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment (time frame: 4 years follow-up). 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 24 Feb 2016.