Allogeneic Hematopoietic Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Hematologic Malignancies - ND

• Conditions: Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Hematologic Malignancies; MedDRA version: 6.1Level: PTClassification code 10028228

• Registration Number: EUCTR2007-005563-10-IT
• Lead Sponsor: FONDAZIONE NEOPLASIE SANGUE ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in any complete remission, Aplastic Anemia, Paroxsymal Nocturnal Hemoglobinuria, Myelodysplastic and Chronic Myeloproliferative Syndromes, Multiple Myeloma. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.

-Elderly patients age > 50 < 70 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants, or because of refusal to undergo conventional myeloablative regimes.

-A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.

-Patient must be competent to give consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.

-Uncontrolled CNS involvement with disease

-Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment

-Females who are pregnant

-Organ dysfunction defined as follows:

Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
Pulmonary: DLCO <40% predicted
Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
Renal: creatinine clearance <50 cc/min (24 hour urine collection)

-Karnofsky performance score < 60%

-Patients with poorly controlled hypertension on multiple antihypertensives

-Documented fungal disease that is progressive despite treatment

-Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis

-Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: A Phase II study evaluating the incidence and severity of acute GVHD following allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning.;Secondary Objective: -To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.<br>-To evaluate the incidence and extent of chronic GVHD. <br>-To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells.<br>-To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate.;Primary end point(s): A Phase II study evaluating the incidence and severity of acute GVHD following allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning.