Mantle Cell LymphomaPhase 2LCM-04-02NCT00505232
Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02)
A Phase 2 study testing Y-90 Ibritumomab tiuxetan in people with Mantle Cell Lymphoma, run by CABYC at 16 sites in Spain.
Trial summary
Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a median survival of 2- 4 years since diagnosis. Although histology is similar to that of an indolent lymphoma, MCL is currently considered an aggressive tumour. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Y-90 Ibritumomab tiuxetan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 16 sitesSpain
- Study dates
- Jan 2006to May 2011
- 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
- All histologic MCL subtypes (WHO classification)
- Age between 18 and 70 years old
- Performance status 0 to 2 (ECOG)
- Cardiac ejection fraction >50%
- Adequate organ (hepatic, cardiac and renal) and marrow function: Hb> 10g/dl, neutrophil counts> 1500/ µl, platelet> 100000/ µl. Creatinine < 2,5xULN, bilirubin, AST or ALT<2,5xULN.
- For Y90-ibritumomab tiuxetan administration: Bone Marrow Infiltration by lymphoma cells < than 25% ; platelet count >100,000/µl and neutrophil counts >1500/µl
- Informed consent should be obtained
Who cannot join
- Ann Arbor stages I or II without B symptoms or bulky disease (>10 cm).
- Previous chemotherapy or radiotherapy treatment.
- Uncontrolled current illness: Hepatic, renal, cardiovascular, neurological or metabolic illness.
- Symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
- HIV, HBV or HCV positive serology.
- Limitation of the patient´s ability to comply with the treatment or follow-up protocol.
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- Men and women with reproductive potential who are not using effective contraceptive methods during and at least 12 months after the end of the study
- Acute or chronic active infection.
- Known hypersensitivity to some of the drugs or other related compounds
- No informed consent obtained
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, Catalonia, 08003
Clinica Ruber
Madrid, Madrid, 28006
Hospital La Princesa
Madrid, Madrid, 28006
Clinica Moncloa
Madrid, Madrid, 28008
Hospital Ramon y Cajal
Madrid, Madrid, 28034
Hospital Universitario Puerta de Hierro
Madrid, Madrid, 28035
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Quiron
Madrid, Madrid, 28224
Hospital Morales Meseguer
Murcia, Murcia, 30008
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clínico de Salamanca
Salamanca, Salamanca, 37007
Hospital Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Clínico de Santiago de Compostela
Santiago de Compostela, Galica, 15705
Hospital Clinico de Valencia
Valencia, Valencia, 46010
Hospital Dr. Peset
Valencia, Valencia, 46017
About this study
Official title: Induction Treatment With Anti-CD20 Plus Hyper-CVAD and Methotrexate/Cytarabine Followed by Consolidation Treatment With Y90 Ibritumomab-Tiuxetan in Patients With Mantle Cell Lymphoma
Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a median survival of 2- 4 years since diagnosis. Although histology is similar to that of an indolent lymphoma, MCL is currently considered an aggressive tumour. Few prospective therapeutic trials have been reported in MCL, and results are difficult to interpret due to treatment heterogeneity. It is known that standard chemotherapy for other clinically aggressive lymphomas yields poor results. Recently, better results have been communicated with intense induction chemotherapy treatments or consolidating the response with high dose chemotherapy with stem cell support. Keeping in mind these considerations, we will use and intensive induction treatment with Hyper-CVAD/MTX-AraC associated with anti-CD20 in order to increase the overall response rate followed by consolidation treatment with Ibritumomab -tiuxetan (Zevalin) with the aim of eradicate the minimal residual disease, responsible of relapse.
Read the detailed description
Study Design:
- The Patients will receive 6 cycles of induction chemotherapy as follows: Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy. After 4 cycles (2 x2), response will be evaluated. If response (complete or partial) is observed, 2 additional cycles will be administrated. If less than a partial response is observed, the patient will be out of the study.
- Consolidation treatment will be a single dose of Y90Ibritumomab -Tiuxetan (Zevalin) will be administered after 12 weeks after completion of induction chemotherapy. The initial dose of Zevalin will be 0.3 mCi/kg, to be further escalated to 0.4 mCi/Kg if unacceptable toxicity does not occur.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Y-90 Ibritumomab tiuxetan
- Keywords
- Y-90 Ibritumomab tiuxetan, Rituximab, Hyper-CVAD, Mantle Cell Lymphoma Patients, Zevalin(R)
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-90 Ibritumomab tiuxetanDrug
Study Design
The present study will be split into two cohorts:
- Patients younger than 60 years who will receive 8 chemotherapy cycles
- Patients older than 60 years who will receive 6 chemotherapy cycles
The induction schema summarises as follows :
Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy twice. Afterward, response will be evaluated, followed by, either, four cycles further patients younger than 60 years who will obtain a CR or PR, or 2 cycles patients older than 60 y. (see figure 1 and flow chart).
Consolidation treatment will consist in a single dose of Y90-Ibritumomab -Tiuxetan (Zevalin) [0.4 mCi/Kg b.w or 0.3 mCi/kg if platelets < 100,000/µl] will be administered 8 to 12 weeks after last chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin | Experimental | Induction Treatment (Rituximab-HCVAD and Methotrexate/Cytarabine) followed by Consolidation Treatment (Rituximab and Y-90 Ibritumomab tiuxetan) Receives: Drug: Y-90 Ibritumomab tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment safety
Safety of the treatment, recording the adverse events throughout the treatment.
Measured: 36 months
Secondary outcomes (4)
Feasibility of proposed treatment scheme.
Number and percentage of patients susceptible of receiving consolidation treatment after induction chemotherapy, according to inclusion criteria for consolidation with radioinmunotherapy.
Measured: 36 months
Efficacy based on response rate: overall, partial and complete response.
Measured: 36 months
Progression free, disease free and overall survivals.
Measured: 36 months
Analysis of the significance of the minimal residual disease (MRD) detection.
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 posted23 Jul 2007 (estimated)
- Study startJan 2006
- Primary completionMar 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CABYC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Responsible party
- Sponsor
- Investigators
- Reyes Arranz, MD, PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505232
- Sponsor's protocol ID
- GELTAMO-LCM-04-02
- Other IDs
- 2005-004400-37, 2005
- Acronym
- LCM-04-02
- Status last verified
- Dec 2011
- First submitted
- 20 Jul 2007
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Treatment With Anti-CD20 Plus Hyper-CVAD and Methotrexate/Cytarabine Followed by Consolidation Treatment With Y90 Ibritumomab-Tiuxetan in Patients With Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00505232
- Acronym / sponsor ID
- LCM-04-02 / GELTAMO-LCM-04-02
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Y-90 Ibritumomab tiuxetan, Rituximab, Hyper-CVAD, Mantle Cell Lymphoma Patients, Zevalin(R)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CABYCIndustry (pharma, biotech, devices)
- Collaborators
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Study start
- Jan 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Jul 2007 (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.
Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a median survival of 2- 4 years since diagnosis. Although histology is similar to that of an indolent lymphoma, MCL is currently considered an aggressive tumour. Few prospective therapeutic trials have been reported in MCL, and results are difficult to interpret due to treatment heterogeneity. It is known that standard chemotherapy for other clinically aggressive lymphomas yields poor results. Recently, better results have been communicated with intense induction chemotherapy treatments or consolidating the response with high dose chemotherapy with stem cell support. Keeping in mind these considerations, we will use and intensive induction treatment with Hyper-CVAD/MTX-AraC associated with anti-CD20 in order to increase the overall response rate followed by consolidation treatment with Ibritumomab -tiuxetan (Zevalin) with the aim of eradicate the minimal residual disease, responsible of relapse.
Detailed description
Study Design:
- The Patients will receive 6 cycles of induction chemotherapy as follows: Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy. After 4 cycles (2 x2), response will be evaluated. If response (complete or partial) is observed, 2 additional cycles will be administrated. If less than a partial response is observed, the patient will be out of the study.
- Consolidation treatment will be a single dose of Y90Ibritumomab -Tiuxetan (Zevalin) will be administered after 12 weeks after completion of induction chemotherapy. The initial dose of Zevalin will be 0.3 mCi/kg, to be further escalated to 0.4 mCi/Kg if unacceptable toxicity does not occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin | Experimental | Drug: Y-90 Ibritumomab tiuxetanInduction Treatment (Rituximab-HCVAD and Methotrexate/Cytarabine) followed by Consolidation Treatment (Rituximab and Y-90 Ibritumomab tiuxetan) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All histologic MCL subtypes (WHO classification)
- Age between 18 and 70 years old
- Performance status 0 to 2 (ECOG)
- Cardiac ejection fraction >50%
- Adequate organ (hepatic, cardiac and renal) and marrow function: Hb> 10g/dl, neutrophil counts> 1500/ µl, platelet> 100000/ µl. Creatinine < 2,5xULN, bilirubin, AST or ALT<2,5xULN.
Key exclusion criteria (10 listed)
- Ann Arbor stages I or II without B symptoms or bulky disease (>10 cm).
- Previous chemotherapy or radiotherapy treatment.
- Uncontrolled current illness: Hepatic, renal, cardiovascular, neurological or metabolic illness.
- Symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
- HIV, HBV or HCV positive serology.
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 |
|---|---|---|
| Y-90 Ibritumomab tiuxetanStudy Design The present study will be split into two cohorts: 1. Patients younger than 60 years who will receive 8 chemotherapy cycles 2. Patients older than 60 years who will receive 6 chemotherapy cycles The induction schema summarises as follows : Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy twice. Afterward, response will be evaluated, followed by, either, four cycles further patients younger than 60 years who will obtain a CR or PR, or 2 cycles patients older than 60 y. (see figure 1 and flow chart). Consolidation treatment will consist in a single dose of Y90-Ibritumomab -Tiuxetan (Zevalin) [0.4 mCi/Kg b.w or 0.3 mCi/kg if platelets < 100,000/µl] will be administered 8 to 12 weeks after last chemotherapy. | Drug | Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin |
Primary outcome
Treatment safety
Time frame: 36 months
Safety of the treatment, recording the adverse events throughout the treatment.
4 secondary outcomes
Feasibility of proposed treatment scheme.
Time frame: 36 months
Efficacy based on response rate: overall, partial and complete response.
Time frame: 36 months
Progression free, disease free and overall survivals.
Time frame: 36 months
Analysis of the significance of the minimal residual disease (MRD) detection.
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 2 Jan 2012.
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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.
Reyes Arranz, MD, PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
16 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 Y-90 Ibritumomab tiuxetan in people with Mantle Cell Lymphoma, run by CABYC at 16 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 7 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 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Treatment safety (time frame: 36 months). 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 2 Jan 2012.