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Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors


Phase 2/Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Acute Myeloblastic Leukemia, Lymphoblastic Leukemia, Myelodysplasia, Chronic Myeloid Leukemia, Myelofibrosis, Lympho-proliferative Diseases

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Trial Information

Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors


The reduction of intensity of conditioning is currently indicated for patients who cannot
undergo standard myelo-ablation due to their age, comorbidities or type of pathology.
Furthermore, the rationale to use RIC regimens is based on the observation that the infusion
of alloreactive donor lymphocytes may yield to a graft versus tumour effect. However, in
this kind of regimens the morbidity and TRM due to GvHD are still a concern and in vivo
T-depletion is a necessary treatment. Both monoclonal (Alemtuzumab) and polyclonal
T-depletion protocols carry risks and benefits. Benefits being a better prophylaxis for
GvHD, and risks being an higher incidence of post-transplantation infections and relapse. At
the moment, it is not clear which type of regimen, monoclonal or polyclonal, is better for
the treatment.


Inclusion Criteria:



- Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic
Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis
(according to IBMDR operative manual)

- Group 2: patients <= 65 yo suffering from lympho-proliferative diseases according the
REAL classification:

- High-doses chemotherapy relapsed CLL (B and T)

- Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after
high-doses chemotherapy

- Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses
chemotherapy

- Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard
chemotherapy regimens or after high-doses chemotherapy

- Advanced (stage ≥ III A) or relapsed T lymphomas

- Large B-cells lymphomas in 2nd or further complete remission after relapse from high
dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens

- Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines
of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of
chemotherapy

- Hodgkin disease relapse after autotransplant with chemosensitive disease or in
relapse after 1 year from chemotherapy and not eligible for autotransplant since an
insufficient mobilization of autologous hemopoietic stem cells.

Exclusion Criteria:

- Performance status < 70% (Karnofsky)

- Left ventricular cardiac ejection fraction < 40% or receiving treatment for heart
failure

- DLCO pulmonary < 40% or receiving continuous oxygen therapy

- Neuropathy (previous or at present)

- Pregnancy

- Patients with arterial hypertension not controlled with multi-pharmacological
treatments

- HIV positive

- B-CLL with clear evidence of transformation into Richter syndrome

- Mycosis fungoides with clear evidence of transformation into blasts

- Hodgkin's disease refractory to chemotherapy

- Absence of informed consent

- Psychiatric disease or other condition compromising the signing of the informed
consent form or compliance with the treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Alessandro Rambaldi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Divisione di Ematologia - Ospedali Riuniti di Bergamo

Authority:

Italy: Ministry of Health

Study ID:

EudraCT:2005-000805-68

NCT ID:

NCT00354120

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Acute Myeloblastic Leukemia
  • Lymphoblastic Leukemia
  • Myelodysplasia
  • Chronic Myeloid Leukemia
  • Myelofibrosis
  • Lympho-proliferative Diseases
  • Primary Myelofibrosis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoproliferative Disorders
  • Myelodysplastic Syndromes
  • Preleukemia

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