Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning

Sponsor

CABYC (Industry)

Overall Status

Terminated

CT.gov ID

NCT00781781

Collaborator

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (Other)

Enrollment

Locations

Arms

Duration (Months)

3.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease	Drug: Alemtuzumab	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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).	Drug: Alemtuzumab 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). Other Names: MabCampath
Experimental: 2 Low Risk patients (no GVHD high risk criterion): Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).	Drug: Alemtuzumab 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). Other Names: MabCampath

Arm

Intervention/Treatment

Experimental: 1

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).

Drug: Alemtuzumab

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).

Other Names:

MabCampath

Experimental: 2

Low Risk patients (no GVHD high risk criterion): Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).

Drug: Alemtuzumab

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).

Other Names:

MabCampath

Outcome Measures

Primary Outcome Measures

Analyze the results of incidence and severity of acute and chronic GVHD [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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.
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.

Exclusion Criteria:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
2	ICO Bellvitge	Hospitalet de Llobregat	Barcelona	Spain	08907
3	Hospital Clinic i Provincial.	Barcelona	Cataluña	Spain	08036
4	Hospital Clinico de Valencia	Valencia	Comunidad Valenciana	Spain	46010
5	Hospital Santa Creu i Sant Pau	Barcelona		Spain	08025
6	Vall de Hebron	Barcelona		Spain
7	Hospital La Princesa	Madrid		Spain	28006
8	Hospital Gregorio Marañon	Madrid		Spain	28007
9	Hospital Ramón y Cajal	Madrid		Spain	28034
10	Hospital Morales Meseguer	Murcia		Spain	30008

Sponsors and Collaborators

CABYC
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

Study Director: Rafael Duarte, MD, Ph.D, ICO Bellvitge. Hospital Duran i Reynals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CABYC

ClinicalTrials.gov Identifier:

NCT00781781

Other Study ID Numbers:

ALOTIRNE-EC06007
2007-006440-22

First Posted:

Oct 29, 2008

Last Update Posted:

Feb 4, 2015

Last Verified:

Oct 1, 2008

Keywords provided by CABYC

Myeloid and Lymphoid malignances

Additional relevant MeSH terms:

Graft vs Host Disease

Alemtuzumab

Study Results

No Results Posted as of Feb 4, 2015