Non-Hodgkin LymphomaPhase 2Z-RIC-AlloNCT00644371
Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study testing Ibritumomab Tiuxetan (Zevalin) in people with Non-Hodgkin Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 14 sites in Spain.
Trial summary
To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Ibritumomab Tiuxetan (Zevalin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 14 sitesSpain
- Study dates
- Nov 2007to 4 Feb 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Histologically confirmed B-cell lymphoma of the following subtypes:
- LBCDL
- Grade 3b follicular lymphoma
- Mantle-cell lymphoma
- Transformed B-cell lymphoma
Show all 18Show fewer
- Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
- High-risk B-cell CD20+ lymphoma defined by
- Having attained less than PR after two chemotherapy lines
- Post-transplantation relapse
- Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation
- Inability to collect enough stem cells for autologous transplantation
- Stable disease at the time of transplantation
- Age between 18 and 65
- Performance status (ECOG) ≤ 2
- Normal and suitable pulmonary function (DLCO ≥ 30%)
- Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%
- Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration)
Who cannot join
- Prior treatment with radiopharmaceutical agents
- HIV-associated lymphoma
- Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)
- Patient's inability to follow the protocol
- Hypersensitivity to 90Y-itritumomab tiuxetan
- Presence of severe pathologies that preclude chemotherapeutic treatment
- Pregnant women or pregnancy risk due to inappropriate contraceptive measures
- Breastfeeding women
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
H. Santa Creu i Sant Pau.
Barcelona, Barcelona.
H.U. 12 de Octubre
Madrid, Madrid
H.U. Gregorio Marañón
Madrid, Madrid
H.U. La Princesa
Madrid, Madrid
H.U. Ramón y Cajal.
Madrid, Madrid
H. Morales Meseguer.
Murcia, Murcia
H. Virgen de la Arrixaca
Murcia, Murcia
H. Central de Asturias
Oviedo, Oviedo
Clinica Universitaria de Navarra
Pamplona, Navarre
H. Clinico de Salamanca
Salamanca, Salamanca
H. U. Marqués de Valdecilla.
Santander, Cantabria
H. Clínico Valencia
Valencia, Valencia
H. La Fe
Valencia, Valencia
H.U. Miguel Servet
Zaragoza, Zaragoza.
About this study
Official title: Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma
To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Ibritumomab Tiuxetan (Zevalin)
- Keywords
- Allogeneic, Lymphoma, GELTAMO, Z-RIC
- 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.
Ibritumomab Tiuxetan (Zevalin)Drug
Also called Rituximab (Mabthera)
Conditioning Regimen
- Rituximab, 250 mg/m2 on days -21 and -14.
- Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.
Chemotherapy:
- Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
- Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.
Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:
- Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
- Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
- Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ibritumomab Tiuxetan (Zevalin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 12 months
Secondary outcomes (7)
safety (toxicity, transplantation- and graft-related mortality)
Measured: 36 months
response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).
Measured: 36 months
overall survival
Measured: 36 months
relapse rate
Measured: 36 months
acute and chronic Graft-versus-Host Disease
Measured: 36 months
haematological and immunological reconstitution, and chimerism.
Measured: Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.
the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startNov 2007
- Primary completion21 Feb 2011
- Study completion4 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- Dolores Caballero, MD, Principal investigator, Hospital Clínico Universitario de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644371
- Sponsor's protocol ID
- GELTAMO-Z-RIC-Allo
- Other IDs
- EuDRACT nº:2007-003302-10
- Acronym
- Z-RIC-Allo
- Status last verified
- Mar 2017
- First submitted
- 18 Mar 2008
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cabrero M, Martin A, Briones J, Gayoso J, Jarque I, Lopez J, Grande C, Heras I, Arranz R, Bernal T, Perez-Lopez E, Lopez-Godino O, Conde E, Caballero D. Phase II Study of Yttrium-90-Ibritumomab Tiuxetan as Part of Reduced-Intensity Conditioning (with Melphalan, Fludarabine +/- Thiotepa) for Allogeneic Transplantation in Relapsed or Refractory Aggressive B Cell Lymphoma: A GELTAMO Trial. Biol Blood Marrow Transplant. 2017 Jan;23(1):53-59. doi: 10.1016/j.bbmt.2016.10.003. Epub 2016 Oct 19.
PubMed 27771496
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00644371
- Acronym / sponsor ID
- Z-RIC-Allo / GELTAMO-Z-RIC-Allo
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Allogeneic, Lymphoma, GELTAMO, Z-RIC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- 21 Feb 2011 (actual)
- Study completion
- 4 Feb 2013 (actual)
- First posted
- 26 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 use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.
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: Ibritumomab Tiuxetan (Zevalin) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Written informed consent
- Histologically confirmed B-cell lymphoma of the following subtypes:
- High-risk B-cell CD20+ lymphoma defined by
- Stable disease at the time of transplantation
- Age between 18 and 65
Key exclusion criteria (8 listed)
- Prior treatment with radiopharmaceutical agents
- HIV-associated lymphoma
- Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)
- Patient's inability to follow the protocol
- Hypersensitivity to 90Y-itritumomab tiuxetan
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 |
|---|---|---|
| Ibritumomab Tiuxetan (Zevalin)Also: Rituximab (Mabthera)Conditioning Regimen 1. Rituximab, 250 mg/m2 on days -21 and -14. 2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14. Chemotherapy: * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion. Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months: * Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8. * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on day -2 as a 15-min infusion. | Drug | 1 |
Primary outcome
progression-free survival
Time frame: 12 months
7 secondary outcomes
safety (toxicity, transplantation- and graft-related mortality)
Time frame: 36 months
response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).
Time frame: 36 months
overall survival
Time frame: 36 months
relapse rate
Time frame: 36 months
acute and chronic Graft-versus-Host Disease
Time frame: 36 months
haematological and immunological reconstitution, and chimerism.
Time frame: Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.
the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival
Time frame: 36 months
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 27 Mar 2017.
- Derived from this study: PubMed 27771496Cabrero M, Martin A, Briones J, Gayoso J, Jarque I, Lopez J, Grande C, Heras I, Arranz R, Bernal T, Perez-Lopez E, Lopez-Godino O, Conde E, Caballero D. Phase II Study of Yttrium-90-Ibritumomab Tiuxetan as Part of Reduced-Intensity Conditioning (with Melphalan, Fludarabine +/- Thiotepa) for Allogeneic Transplantation in Relapsed or Refractory Aggressive B Cell Lymphoma: A GELTAMO Trial. Biol Blood Marrow Transplant. 2017 Jan;23(1):53-59. doi: 10.1016/j.bbmt.2016.10.003. Epub 2016 Oct 19.
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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.
Dolores Caballero, MD principal investigator
Hospital Clínico Universitario de Salamanca
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 Ibritumomab Tiuxetan (Zevalin) in people with Non-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 8 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 27 Mar 2017. 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?
progression-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00644371, which also lists 1 linked publication.
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 27 Mar 2017.