CLASSICAL HODGKIN LYMPHOMAPhase 1/2NCT02243436
Brentuximab Vedotin in Pre-transplant Induction and Consolidation for Relapsed or Refractory Hodgkin Lymphoma
A Phase 1/2 study testing Brentuximab Vedotin, Etoposide and Soludomerin in people with CLASSICAL HODGKIN LYMPHOMA, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 14 sites in Spain.
Trial summary
Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLASSICAL HODGKIN LYMPHOMA
- What is being tested?
- Brentuximab Vedotin, Etoposide and Soludomerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 14 sitesSpain
- Study dates
- 11 Nov 2014to 14 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
- Histologically confirmed relapsed or refractory classical HL after first line chemotherapy. CD30 has to be positive
- Age 18 to 65 years. Patient >65 years old with ECOG ≤1 and absence of comorbidities will be included in the study
- ECOG ≤2
- Karnofsky performance status ≥ 60
- No major organ dysfunction
Show all 18Show fewer
- Biopsy at HL relapse or when refractoriness disease is diagnosed must be done prior to BV-ESHAP. If biopsy cannot be performed, tumor biopsy at initial diagnosis of HL must be available to be revised
- Absence of prior history of other malignant diseases, except:
- Basal cell carcinoma of the skin or uterine "in situ" carcinoma adequately treated Any curable neoplasia adequately treated that has achieved complete response and has remained in such status longer than 3 years
- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
- Male patients, even if surgically sterilized, agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
- Life-expectancy >3 months
- Platelet count ≥75•109/L (or 20 if due to Bone Marrow [BM] infiltration) absolute neutrophil count ≥1.5•109/L (or 0.5 if due to BM infiltration), and hemoglobin ≥ 8g/dL
- Total Bilirubin: <1.5 x UNL, unless clearly related to the disease (Gilbert disease will be ruled out from this point)
- AST and ALT: <3 xUNL except liver infiltration
- Serum creatinine: < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
- Serum sodium >130 mmol/L
- Voluntary written informed consent
Who cannot join
- Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Patients that have been treated previously with anti-CD30 monoclonal antibodies
- Myocardial infarction within 6 months prior to enrollment. Heart failure NYHA Class III-IV, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Recent evidence (within 6 months) of a left-ventricular ejection fraction <50%
- Peripheral neuropathy or neuropathic pain grade ≥ 2
- Known cerebral or meningeal disease, including signs or symptoms of PML
Show all 16Show fewer
- Symptomatic neurologic disease compromising normal activities of daily living or requiring medication
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in brentuximab vedotin
- Pregnant women or in breast-feeding period, or adults in childbearing period not using an effective contraception method
- Treatment with any known non-marketed drug substance or experimental therapy within the longer of 5 terminal half-lives or 4 weeks prior to enrollment or currently participating in any other interventional clinical study
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment within two weeks prior to first study drug dose
- History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- HIV positive
- Significant concurrent, uncontrolled medical condition which may represent a risk for the patient
- Positive serology for HBV
- Positive serology for HCV
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Institut Català d'Oncologia, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Institut Català d'Oncologia, Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Son Espases
Palma, Balearic Islands
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Clínico de Valencia
Valencia, 46010
About this study
Official title: Phase I-II Clinical Trial for the Evaluation of Brentuximab Vedotin Plus Etoposide, Solumoderin (Methylprednisolone), High Dose ARA-C (Cytarabine) and Cisplatin in the Transplant and Post-transplant Management for Relapsed or Refractory Classical Hodgkin Lymphoma Patients
Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation.
Read the detailed description
Most patients suffering from Hodgkin's lymphoma (HL) can be successfully treated with standard chemo- and/or radiotherapy. However, in patients with refractory disease/relapsing after first line of therapy, conventional-dose chemotherapy regimens induce low remission rates, with long-term disease free survival not higher than 10% of patients.
High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the standard treatment for these patients. This treatment approach results in long-term remissions in approximately 40-50% of relapsed patients, and in up to 25-30% of those with primary refractory disease. The possibility of a cure depends on several prognostic factors, however, in almost all series, the strongest prognostic factor has been the disease status before ASCT. Patients with HL who do not achieve complete remission (CR) after induction chemotherapy and those with unresponsive relapse have a very poor prognosis. Therefore, the choice of a very active pre-transplant salvage chemotherapy regimen is extremely important to improve results after ASCT. In addition, this activity should also be combined with a good stem cell mobilizing potential and low toxicity profiled.
Several pre-transplant salvage regimens for refractory/relapsed HL are currently used with an overall response (OR) and CR rates ranging from 60% to 88% and from 17% to 49%, respectively. No randomized trial exists comparing the effectiveness of these regimens. ESHAP (Etoposide, Solumoderin (methylprednisolone), Ara-C (Cytarabine) and cisplatin) is one of the most commonly used regimens. ESHAP induces an OR and CR of 73% and 41%, respectively, with 5% toxic deaths. In the present study, a combination of ESHAP plus Brentuximab Vedotin (BV) is proposed as pre-transplant therapy with the aim to improve the CR rate before ASCT.
HL is characterized by the presence of CD30-positive Hodgkin Reed-Sternberg cells. The antibody-drug conjugate BV delivers the highly potent antimicrotubule agent monomethyl auristatin E (MMAE) to CD30-positive malignant cells by binding specifically to CD30 on the cell surface and releasing MMAE inside the cell via lysosomal degradation.
Binding of MMAE to tubulin results in apoptotic death of the CD30 expressing tumor cell.
- Conditions
- CLASSICAL HODGKIN LYMPHOMA
- Keywords
- CLASSICAL HODGKIN LYMPHOMA, HODGKIN LYMPHOMA, LYMPHOMA, HL
- 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.
Brentuximab VedotinDrug
Also called ADCETRIS
Brentuximab Vedotin, 0.9mg/kg, 1.2mg/kg, 1.8mg/kg, day 1
EtoposideDrug
Intravenose use, 40mg/m2/day, on days 1 to 4
SoludomerinDrug
Also called Methylprednisolone
Intravenous use, 250mg/day, on days 1 to 4
CisplatinDrug
Intravenous use, 25mg/m2/day, on days 1 to 4
Ara CDrug
Also called Cytarabine
Intravenous use, 2g/m2, day 5
| Study group | Role | What they receive |
|---|---|---|
| BV-ESHAP | Experimental | 1. - 3 cycles every 21 days:
* Brentuximab Vedotin, on day 1 (BV will be administered at three different doses 0.9mg/kg, 1.2mg/kg, 1.8mg/kg)
* Etoposide 40 mg/m2/day, on days 1 to 4
* Soludomerin (methylprednisolone) 250 mg/day, on days 1 to 4
* Cisplatin 25 mg/m2/day, on days 1 to 4
* Ara C (cytarabine) 2 g/m2, on day 5
2. - A fourth dose of BV will be given 21 days after the third BV dose during the evaluation of response before the transplant.
3. - Autologous peripheral blood stem cell transplant
4. - A fifth dose of BV (1.8mg/kg) will be given on between day 28 and 35 post-transplant, followed by two additional doses (1.8mg/kg) every 3 weeks, to complete a total of 7 BV infusions. Receives: Drug: Brentuximab Vedotin; Drug: Etoposide; Drug: Soludomerin; Drug: Cisplatin; Drug: Ara C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose
During phase I, defined as the maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant HL patients.
Measured: Day 21 of cycle 1 (3 weeks after start of treatment)
Global response rate prior to ASCT
During phase II, Global response rate after BV-ESHAP as salvage regimen prior to ASCT.
Measured: 9 weeks (after start of treatment)
Complete response
Percentage of patients with complete response rate after BV-ESHAP as salvage regimen prior to ASCT.
Measured: 9 weeks (after start of treatment)
Secondary outcomes (11)
Toxicity according to the CTC criteria
To determine the toxicity of BV-ESHAP regimen
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Stem cell mobilization capacity
To assess the stem cell mobilization capacity of the BV-ESHAP regimen: determine the expanse and effectiveness of the extraction of stem cells from peripheral blood.
Measured: After first or second cycle of treatment
Transplant-related mortality (TRM)
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Overall Survival (OS)
Percentage of patients alive after first dose of treatment through follow-up
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Progression free survival (PFS)
Percentage of patients without progression of disease
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Event-Free Survival
Percentage of patients without event
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Time to HL Progression
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Disease-Free Survival
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Response Duration
Length of time between date of evidenced response and progression of disease or death
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Lymphoma-Specific Survival
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Time to Next Treatment
Measured: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study start11 Nov 2014
- Primary completionJan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLASSICAL 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Ramón García-Sanz, MD, Study chair, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243436
- Sponsor's protocol ID
- BRESHAP-GELTAMO.LH-2013
- Other IDs
- 2014-000835-17, 2014
- Status last verified
- Apr 2019
- First submitted
- 27 Aug 2014
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Clinical Trial for the Evaluation of Brentuximab Vedotin Plus Etoposide, Solumoderin (Methylprednisolone), High Dose ARA-C (Cytarabine) and Cisplatin in the Transplant and Post-transplant Management for Relapsed or Refractory Classical Hodgkin Lymphoma Patients
- ClinicalTrials.gov ID
- NCT02243436
- Acronym / sponsor ID
- BRESHAP-GELTAMO.LH-2013
- Conditions
- CLASSICAL HODGKIN LYMPHOMA
- Keywords
- CLASSICAL HODGKIN LYMPHOMA, HODGKIN LYMPHOMA, LYMPHOMA, HL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 18 Sep 2014 (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.
Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation.
Detailed description
Most patients suffering from Hodgkin's lymphoma (HL) can be successfully treated with standard chemo- and/or radiotherapy. However, in patients with refractory disease/relapsing after first line of therapy, conventional-dose chemotherapy regimens induce low remission rates, with long-term disease free survival not higher than 10% of patients.
High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the standard treatment for these patients. This treatment approach results in long-term remissions in approximately 40-50% of relapsed patients, and in up to 25-30% of those with primary refractory disease. The possibility of a cure depends on several prognostic factors, however, in almost all series, the strongest prognostic factor has been the disease status before ASCT. Patients with HL who do not achieve complete remission (CR) after induction chemotherapy and those with unresponsive relapse have a very poor prognosis. Therefore, the choice of a very active pre-transplant salvage chemotherapy regimen is extremely important to improve results after ASCT. In addition, this activity should also be combined with a good stem cell mobilizing potential and low toxicity profiled.
Several pre-transplant salvage regimens for refractory/relapsed HL are currently used with an overall response (OR) and CR rates ranging from 60% to 88% and from 17% to 49%, respectively. No randomized trial exists comparing the effectiveness of these regimens. ESHAP (Etoposide, Solumoderin (methylprednisolone), Ara-C (Cytarabine) and cisplatin) is one of the most commonly used regimens. ESHAP induces an OR and CR of 73% and 41%, respectively, with 5% toxic deaths. In the present study, a combination of ESHAP plus Brentuximab Vedotin (BV) is proposed as pre-transplant therapy with the aim to improve the CR rate before ASCT.
HL is characterized by the presence of CD30-positive Hodgkin Reed-Sternberg cells. The antibody-drug conjugate BV delivers the highly potent antimicrotubule agent monomethyl auristatin E (MMAE) to CD30-positive malignant cells by binding specifically to CD30 on the cell surface and releasing MMAE inside the cell via lysosomal degradation.
Binding of MMAE to tubulin results in apoptotic death of the CD30 expressing tumor cell.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BV-ESHAP | Experimental | Drug: Brentuximab Vedotin, Drug: Etoposide, Drug: Soludomerin, Drug: Cisplatin, Drug: Ara C1. - 3 cycles every 21 days: * Brentuximab Vedotin, on day 1 (BV will be administered at three different doses 0.9mg/kg, 1.2mg/kg, 1.8mg/kg) * Etoposide 40 mg/m2/day, on days 1 to 4 * Soludomerin (methylprednisolone) 250 mg/day, on days 1 to 4 * Cisplatin 25 mg/m2/day, on days 1 to 4 * Ara C (cytarabine) 2 g/m2, on day 5 2. - A fourth dose of BV will be given 21 days after the third BV dose during the evaluation of response before the transplant. 3. - Autologous peripheral blood stem cell transplant 4. - A fifth dose of BV (1.8mg/kg) will be given on between day 28 and 35 post-transplant, followed by two additional doses (1.8mg/kg) every 3 weeks, to complete a total of 7 BV infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
- Histologically confirmed relapsed or refractory classical HL after first line chemotherapy. CD30 has to be positive
- Age 18 to 65 years. Patient >65 years old with ECOG ≤1 and absence of comorbidities will be included in the study
- ECOG ≤2
- Karnofsky performance status ≥ 60
Key exclusion criteria (16 listed)
- Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Patients that have been treated previously with anti-CD30 monoclonal antibodies
- Myocardial infarction within 6 months prior to enrollment. Heart failure NYHA Class III-IV, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Recent evidence (within 6 months) of a left-ventricular ejection fraction <50%
- Peripheral neuropathy or neuropathic pain grade ≥ 2
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 |
|---|---|---|
| Brentuximab VedotinAlso: ADCETRISBrentuximab Vedotin, 0.9mg/kg, 1.2mg/kg, 1.8mg/kg, day 1 | Drug | BV-ESHAP |
| EtoposideIntravenose use, 40mg/m2/day, on days 1 to 4 | Drug | BV-ESHAP |
| SoludomerinAlso: MethylprednisoloneIntravenous use, 250mg/day, on days 1 to 4 | Drug | BV-ESHAP |
| CisplatinIntravenous use, 25mg/m2/day, on days 1 to 4 | Drug | BV-ESHAP |
| Ara CAlso: CytarabineIntravenous use, 2g/m2, day 5 | Drug | BV-ESHAP |
Primary outcome
Recommended dose
Time frame: Day 21 of cycle 1 (3 weeks after start of treatment)
During phase I, defined as the maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant HL patients.
Global response rate prior to ASCT
Time frame: 9 weeks (after start of treatment)
During phase II, Global response rate after BV-ESHAP as salvage regimen prior to ASCT.
Complete response
Time frame: 9 weeks (after start of treatment)
Percentage of patients with complete response rate after BV-ESHAP as salvage regimen prior to ASCT.
11 secondary outcomes
Toxicity according to the CTC criteria
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Stem cell mobilization capacity
Time frame: After first or second cycle of treatment
Transplant-related mortality (TRM)
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Overall Survival (OS)
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Progression free survival (PFS)
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Event-Free Survival
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Time to HL Progression
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Disease-Free Survival
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Response Duration
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Lymphoma-Specific Survival
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 years.
Time to Next Treatment
Time frame: Prior every cycle, 14th day of first three cycles, at week 12, 16, 19, 22, 25, 31. Every 12 weeks for 2 years and then every 24 week up to 5 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 24 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Ramón García-Sanz, MD study chair
University of Salamanca
14 sites 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 Brentuximab Vedotin, Etoposide and Soludomerin in people with CLASSICAL HODGKIN LYMPHOMA, 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 18 inclusion and 16 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 Apr 2019. 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 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?
Recommended dose (time frame: Day 21 of cycle 1 (3 weeks after start of treatment)). The study lists 3 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 24 Apr 2019.