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Allogeneic Hematopoietic Stem Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-thymocyte Globulin for Older Patients With Relapsed Lymphoid Malignancies


Phase 2
50 Years
66 Years
Open (Enrolling)
Both
Patient With Hemato-lymphoid Malignancies or Syndromes in Whom Allogeneic Stem Cell Transplantation is Warranted

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Trial Information

Allogeneic Hematopoietic Stem Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-thymocyte Globulin for Older Patients With Relapsed Lymphoid Malignancies


Inclusion Criteria:



- Any patient with one of the following hemato-lymphoid malignancies or syndromes in
whom allogeneic stem cell transplantation is warranted. Specific disease categories
include: non-follicular indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell
Lymphoma, Marginal zone lymphoma, MALT, T cell lymphoma, Chronic Lymphocytic or
prolymphocytic Leukemia, Hodgkin Disease, and Waldenström macroglobulinemia. T-cell
NOS, angioimmunoblastic lymphoma, HTLV1, T-gamma/delta, anaplastic lymphoma and
Sezeay syndromes can be included after careful assessment by the PI and the protocol
steering committee.

- Patients must be at least in partial remission (according to standard criteria) after
salvage therapy and before (~one month) the start of the conditioning regimen.

- Patient age >50 and less than 66 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.

- A fully HLA-identical sibling or matched unrelated donor is available (10/10 HLA
match). 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.

Exclusion Criteria:

- Patients with progressive hematolymphoid malignancies despite conventional therapies,
and not in partial remission during the month preceding transplantation.

- Patients with DLBCL or cutaneous T cell lymphoma

- 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

- Renal: Serum creatinine >1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the
estimated glomerular fil-tration rate (GFR) must be >60 mL/min/1.73 m²

- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or
transaminases >4x the upper limit of normal

- Karnofsky performance score < 70%

- 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.

- Patients with prior malignancies diagnosed > 5 years ago without evidence of disease
are eligible. Patients with a prior malignancy treated < 5 years ago but have a life
expectancy of > 5 years for that malignancy are eligible.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

To evaluate the incidence of non-relapse mortality (NRM)

Outcome Time Frame:

one year after transplantation

Principal Investigator

Mohamad MOHTY, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

10/6-L

NCT ID:

NCT01566656

Start Date:

March 2012

Completion Date:

March 2015

Related Keywords:

  • Patient With Hemato-lymphoid Malignancies or Syndromes in Whom Allogeneic Stem Cell Transplantation is Warranted
  • Allogeneic hematopoietic stem cell transplantation
  • Non-myeloablative preparative regimen
  • Total lymphoid irradiation
  • Anti-thymocyte globulin
  • Lymphoid malignancies
  • Neoplasms

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