Graft Versus Host DiseasePhase 2NCT00781781
Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning
A Phase 2 study testing Alemtuzumab in people with Graft Versus Host Disease, run by CABYC at 10 sites in Spain.
Trial summary
The purpose of this study is to analyze the results of incidence and severity of acute and chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity conditioning. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Alemtuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 10 sitesSpain
- Study dates
- Jul 2008to Dec 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with haematological or lymphoid malignancies with allogenic transplantation indication:
- High risk follicular NHL, mantle HHC and other low grade NHC (e.g lymphoplasmacytic, extranodal or from marginal zone).
- Disease that does not obtain a CR with Fludarabine or antiCD-20 including chemotherapy.
- Relapse after autologous transplant.
- Non candidates to autologous transplant in 2nd CR (e.g. mobilization failure, or persistent marrow infiltrate).
- Poor prognosis chronic lymphoblastic leukaemia (CLL): Del 11q, Del 17p, complex cariotype; B symptoms, progressive low cell count by marrow infiltration, lymphocytosis or enlarged lymph nodes, or progressive spleen growth.
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- High grade lymphoma transformed from a low grade non Hodgkin's lymphoma or from a chronic lymphocitic leukaemia
- High risk T peripheral lymphoma, with IPI > or = 2, non susceptible of autologous transplant, or relapsed after autologous transplant
- Primarily refractory high risk Hodgkin's disease, relapse in patients not susceptible of autologous transplant or relapse after autologous transplant.
- High risk acute mieloblastic leukaemia (AML) in 1st CR, or AMC > or = 2 CR, including AML after MDS and secondary AML.
- High risk acute lymphoblastic leukaemia (ALL) because of poor response to induction chemotherapy (>10% blasts day +14 or no RC day +28-35), or by cytogenetic criteria: Ph+ or 11q23.
- High risk myelodisplastic syndromes (SMD) type RAEB-1 or AREB-2 with IPSS >Int-1.
- For the inclusion in transplant patients with ALL or AML must be in CR, patients with MDS must have <10% blasts en la BM, and patients with lymphoid malignancies must show previous chemosensitivity, with PR or CR.
- Patients 40 to 65 years old. Patients outside this age range could be included according to participating centres criteria.
- Patients in the study population lacking a compatible related donor, and with a possible compatible unrelated donor (>=9/10 by 10 alleles high resolution typing: HLA-A, B, C, DRB1, DQB1) to assign the patients to a risk in subgroup.
- Signed informed consent.
- Not fulfilling any of the following exclusion criteria.
Who cannot join
- Liver (≥ x3 UNL), kidney (GF <40ml/min), cardiac (LVEF <40%) or respiratory (DLCO \& FVC <40% of expected) function tests impairment.
- HIV injection.
- Absence of signed informed consent.
- Progressive disease previous to transplant or not fulfilling the above mentioned response criteria.
- Other co-morbidities that contraindicate CT.
- Pregnant and/or breast-feeding women or with pregnancy risk by inadequate contraception.
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- Life expectancy <6 months.
- Mental or psychiatric deficiency impeding adequate understanding and consent to therapy
- Hypersensitivity as shown by anaphylactic reaction to any of the DRUGS used in the trial.
- Active infectious process.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Vall de Hebron
Barcelona, Barcelona
Hospital Clinic i Provincial.
Barcelona, Catalonia, 08036
ICO Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital La Princesa
Madrid, Madrid, 28006
Hospital Gregorio Marañon
Madrid, Madrid, 28007
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Morales Meseguer
Murcia, Murcia, 30008
Hospital Clinico de Valencia
Valencia, Valencia, 46010
About this study
Official title: Multicenter, Openlabel, Phase II Intergroups (GELTAMO/GETH) Trial, on the Use of Alemtuzumab for Unrelated Donor Reduced Intensity Conditioning Allogenic Transplant in Hematological Malignancies Patients
The purpose of this study is to analyze the results of incidence and severity of acute and chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity conditioning.
Read the detailed description
Each patient will be assigned to one of the two dosing schedules and total dose of drug envisaged in the study. The assignation to conventional or reduced Alemtuzumab (MabCampath) dose will be done depending on the age and risk of suffering GVHD, in function of variables coming from general experience.
High risk of GVHD criteria:
Gender incompatibility: male patient of female donor. HLA incompatibility: non identical high resolution typing in HLA A, B, C, DRB1, DQB1 (identity less than 10/10 alleles by high resolution) Age of patient more or equal than 55 years
Conventional doses in high risk (at least one criterion of GVHD high risk):
100 mg de Alemtuzumab IV total dose in 5, 20 mg fractions, days -8, -7, -6, -5 and -4.
Reduced dose in low risk cases (no criteria of GVHD high risk):
50 mg de Alemtuzumab IV total dose en 5 fractions of 10 mg, days -5, -4, -3, -2 and -1.
- Conditions
- Graft Versus Host Disease
- Being tested
- Alemtuzumab
- Keywords
- Myeloid and Lymphoid malignances
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabDrug
Also called MabCampath
High risk: Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive) Low risk: Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | High risk patients (at least one GVHD high risk criterion):
Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive). Receives: Drug: Alemtuzumab |
| 2 | Experimental | Low Risk patients (no GVHD high risk criterion):
Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive). Receives: Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the results of incidence and severity of acute and chronic GVHD
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionDec 2011
Why it stopped: Inability to recruit the number of patients established in the study protocol (34 of 40)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- Rafael Duarte, MD, Ph.D, Study director, ICO Bellvitge. Hospital Duran i Reynals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781781
- Sponsor's protocol ID
- ALOTIRNE-EC06007
- Other IDs
- 2007-006440-22
- Status last verified
- Oct 2008
- First submitted
- 28 Oct 2008
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Openlabel, Phase II Intergroups (GELTAMO/GETH) Trial, on the Use of Alemtuzumab for Unrelated Donor Reduced Intensity Conditioning Allogenic Transplant in Hematological Malignancies Patients
- ClinicalTrials.gov ID
- NCT00781781
- Acronym / sponsor ID
- ALOTIRNE-EC06007
- Conditions
- Graft Versus Host Disease
- Keywords
- Myeloid and Lymphoid malignances
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit the number of patients established in the study protocol (34 of 40)
- Enrolment
- 34 participants (actual)
- Lead sponsor
- CABYCIndustry (pharma, biotech, devices)
- Collaborators
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Oct 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.
The purpose of this study is to analyze the results of incidence and severity of acute and chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity conditioning.
Detailed description
Each patient will be assigned to one of the two dosing schedules and total dose of drug envisaged in the study. The assignation to conventional or reduced Alemtuzumab (MabCampath) dose will be done depending on the age and risk of suffering GVHD, in function of variables coming from general experience.
High risk of GVHD criteria:
Gender incompatibility: male patient of female donor. HLA incompatibility: non identical high resolution typing in HLA A, B, C, DRB1, DQB1 (identity less than 10/10 alleles by high resolution) Age of patient more or equal than 55 years
Conventional doses in high risk (at least one criterion of GVHD high risk):
100 mg de Alemtuzumab IV total dose in 5, 20 mg fractions, days -8, -7, -6, -5 and -4.
Reduced dose in low risk cases (no criteria of GVHD high risk):
50 mg de Alemtuzumab IV total dose en 5 fractions of 10 mg, days -5, -4, -3, -2 and -1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AlemtuzumabHigh risk patients (at least one GVHD high risk criterion): Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive). |
| 2 | Experimental | Drug: AlemtuzumabLow Risk patients (no GVHD high risk criterion): Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with haematological or lymphoid malignancies with allogenic transplantation indication:
- For the inclusion in transplant patients with ALL or AML must be in CR, patients with MDS must have <10% blasts en la BM, and patients with lymphoid malignancies must show previous chemosensitivity, with PR or CR.
- Patients 40 to 65 years old. Patients outside this age range could be included according to participating centres criteria.
- Patients in the study population lacking a compatible related donor, and with a possible compatible unrelated donor (>=9/10 by 10 alleles high resolution typing: HLA-A, B, C, DRB1, DQB1) to assign the patients to a risk in subgroup.
- Signed informed consent.
Key exclusion criteria (10 listed)
- Liver (≥ x3 UNL), kidney (GF <40ml/min), cardiac (LVEF <40%) or respiratory (DLCO \& FVC <40% of expected) function tests impairment.
- HIV injection.
- Absence of signed informed consent.
- Progressive disease previous to transplant or not fulfilling the above mentioned response criteria.
- Other co-morbidities that contraindicate CT.
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 |
|---|---|---|
| AlemtuzumabAlso: MabCampathHigh risk: Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive) Low risk: Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive). | Drug | 1, 2 |
Primary outcome
Analyze the results of incidence and severity of acute and chronic GVHD
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Inability to recruit the number of patients established in the study protocol (34 of 40)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Rafael Duarte, MD, Ph.D study director
ICO Bellvitge. Hospital Duran i Reynals
10 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 Alemtuzumab in people with Graft Versus Host Disease, run by CABYC at 10 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: stopped early, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 was stopped early (reason given: Inability to recruit the number of patients established in the study protocol (34 of 40)). Results are not available in the source record.
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?
Analyze the results of incidence and severity of acute and chronic GVHD (time frame: 3 years). 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 4 Feb 2015.