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

NCT00781781 | Terminated Phase 2

• 2 other identifiers: ALOTIRNE-EC060072007-006440-22
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 10

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.

Conditions

Graft Versus Host Disease

Keywords

Myeloid and Lymphoid malignances

Outcome Measures

Primary Outcomes (1)

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

  3 years

Study Arms (2)

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).

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).

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

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).

Also known as: MabCampath

1; 2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CABYC: lead
• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: collaborator

Study Sites (10)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Vall de Hebron

Barcelona, Barcelona, Spain

Location

ICO Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clinic i Provincial.

Barcelona, Catalonia, 08036, Spain

Location

Hospital La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Hospital Clinico de Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rafael Duarte, MD, Ph.D

  ICO Bellvitge. Hospital Duran i Reynals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2011
• Last Updated: February 4, 2015

Record last verified: 2008-10

Locations

ES (10)