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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by CABYC.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Information provided by (Responsible Party):
CABYC
ClinicalTrials.gov Identifier:
NCT00781781
First received: October 28, 2008
Last updated: December 28, 2011
Last verified: October 2008
  Purpose

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 Intervention Phase
Graft Versus Host Disease
Drug: Alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CABYC:

Primary Outcome Measures:
  • Analyze the results of incidence and severity of acute and chronic GVHD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: July 2008
Estimated Study Completion Date: September 2012
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: MabCampath

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

      1. Disease that does not obtain a CR with Fludarabine or antiCD-20 including chemotherapy.
      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 >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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781781

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
ICO Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic i Provincial.
Barcelona, Cataluña, Spain, 08036
Hospital Clinico de Valencia
Valencia, Comunidad Valenciana, Spain, 46010
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Vall de Hebron
Barcelona, Spain
Hospital Gregorio Marañon
Madrid, Spain, 28007
Hospital La Princesa
Madrid, Spain, 28006
Hospital Ramón y Cajal
Madrid, Spain, 28034
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
  More Information

No publications provided

Responsible Party: CABYC
ClinicalTrials.gov Identifier: NCT00781781     History of Changes
Other Study ID Numbers: ALOTIRNE-EC06007, 2007-006440-22
Study First Received: October 28, 2008
Last Updated: December 28, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by CABYC:
Myeloid and Lymphoid malignances

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014