Non-Hodgkin's LymphomaPhase 2Z-BEAM LDGGBNCT00646750
Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom
A Phase 2 study testing Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan) in people with Non-Hodgkin's Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 18 sites in Spain.
Trial summary
To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 18 sitesSpain
- Study dates
- Jan 2008to Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give their written informed consent.
- Abide by at least one of the following conditions:
- Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else
- Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like.
- Patients on first recidivation who do not attain partial remission after salvage chemotherapy.
- Patients with transformed lymphoma, on first partial remission (No CR).
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- Stable disease at the time of transplantation.
- Age ≥ 18 but ≤ 70.
- Life expectancy of greater than three months.
- Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:
- Performance status (ECOG) < 3.
- FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
- Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
- Total bilirubin and transaminases < 3 times the normal maximum value, except if attributable to the underlying disease.
- Creatinine < 2 times the maximum normal value, and creatinine clearance > 40 ml/min, except if attributable to the underlying disease.
- Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.
- HIV negative.
Who cannot join
- Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.
- Known hypersensitivity to mouse proteins.
- Involvement of CNS by lymphoma.
- Progressive lymphoma during the month prior to the date of transplantation.
- Previous radioimmunotherapy.
- Previous autologous transplantation of haematopoietic stem cells.
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- Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method.
- Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial.
- Active psychiatric disease, including addiction disorders.
- Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital Universitario de Alicante
Alicante, Alicante
H. de la Santa Creu i Sant Pau
Barcelona, Barcelona
Instituto Catalán de Oncología,
Barcelona, Barcelona
H. Reina Sofía
Córdoba, Córdoba
Clínica Puerta de Hierro,
Madrid, Madrid
H.U. 12 de Octubre,
Madrid, Madrid
H.U. Gregorio Marañón,
Madrid, Madrid
H.U. La Paz
Madrid, Madrid
H.U. La Princesa
Madrid, Madrid
M.D. Anderson Internacional
Madrid, Madrid
H. Morales Messeguer
Murcia, Murcia
H.U. Virgen de la Arrixaca
Murcia, Murcia
H.U. Central de Asturias, Oviedo
Oviedo, Principality of Asturias
Clínica Universitaria de Navarra
Pamplona, Navarre
H. Clínico Universitario de Salamanca
Salamanca, Salamanca
H.Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands
H.U. Marqués de Valdecilla
Santander, Cantabria
H.U. La Fe
Valencia, Valencia
About this study
Official title: Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-cell Diffuse Lymphom
To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
- Keywords
- Z-BEAM, Autologous, Lymphoma, GELTAMO
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)Drug
Also called Ybritumomab Tiuxetan (Zevalin), Rituximab (Mabthera)
Day -21: rituximab. 250 mg/m2 iv
Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi).
Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BEAM preceded by Ybritumomab Tiuxetan (Zevalin) Receives: Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease clinical response to treatment - complete response rate.
Measured: Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation
Secondary outcomes (5)
Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.
Measured: 36 months
Overall response rate (complete + partial response)
Measured: 36 month
Progression-free-survival
Measured: 36 month
Overall survival
Measured: 96 months
Post-transplantation haematological and immunological reconstitution
Measured: Until post-transplantation day +100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's 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
- 31 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
- Javier Briones, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauDolores Caballero, MD, Principal investigator, Hospital Clínico Universitario de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646750
- Sponsor's protocol ID
- GELTAMO-Z-BEAM LDGGB
- Other IDs
- EudraCT No.: 2007-003198 - 22
- Acronym
- Z-BEAM LDGGB
- Status last verified
- Feb 2016
- First submitted
- 17 Mar 2008
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-cell Diffuse Lymphom
- ClinicalTrials.gov ID
- NCT00646750
- Acronym / sponsor ID
- Z-BEAM LDGGB / GELTAMO-Z-BEAM LDGGB
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Z-BEAM, Autologous, Lymphoma, GELTAMO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Mar 2008 (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.
To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)BEAM preceded by Ybritumomab Tiuxetan (Zevalin) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Give their written informed consent.
- Abide by at least one of the following conditions:
- Stable disease at the time of transplantation.
- Age ≥ 18 but ≤ 70.
- Life expectancy of greater than three months.
Key exclusion criteria (10 listed)
- Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.
- Known hypersensitivity to mouse proteins.
- Involvement of CNS by lymphoma.
- Progressive lymphoma during the month prior to the date of transplantation.
- Previous radioimmunotherapy.
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 |
|---|---|---|
| Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)Also: Ybritumomab Tiuxetan (Zevalin), Rituximab (Mabthera)Day -21: rituximab. 250 mg/m2 iv Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi). Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1. | Drug | 1 |
Primary outcome
Disease clinical response to treatment - complete response rate.
Time frame: Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation
5 secondary outcomes
Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.
Time frame: 36 months
Overall response rate (complete + partial response)
Time frame: 36 month
Progression-free-survival
Time frame: 36 month
Overall survival
Time frame: 96 months
Post-transplantation haematological and immunological reconstitution
Time frame: Until post-transplantation day +100
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 15 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.
Javier Briones, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Dolores Caballero, MD principal investigator
Hospital Clínico Universitario de Salamanca
18 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 Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan) in people with Non-Hodgkin's Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 18 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 17 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: finished, as of the sponsor's last update on 15 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 18 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?
Disease clinical response to treatment - complete response rate. (time frame: Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation). 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 15 Feb 2016.