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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

Phase 2
40 Years
65 Years
Open (Enrolling)
Graft Versus Host Disease

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Trial Information

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

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.

Inclusion Criteria

Inclusion criteria:

- Patients with haematological or lymphoid malignancies with allogenic transplantation

- High risk follicular NHL, mantle HHC and other low grade NHC (e.g
lymphoplasmacytic, extranodal or from marginal zone).

1. Disease that does not obtain a CR with Fludarabine or antiCD-20 including

2. Relapse after autologous transplant.

3. 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

- 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

- Life expectancy <6 months.

- Mental or psychiatric deficiency impeding adequate understanding and consent to

- Hypersensitivity as shown by anaphylactic reaction to any of the DRUGS used in the

- Active infectious process.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Analyze the results of incidence and severity of acute and chronic GVHD

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Rafael Duarte, MD, Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

ICO Bellvitge. Hospital Duran i Reynals


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

July 2008

Completion Date:

September 2012

Related Keywords:

  • Graft Versus Host Disease
  • Myeloid and Lymphoid malignances
  • Graft vs Host Disease