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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

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Haemato-lymphoid Malignancies or Syndromes in Whom Allogeneic Stem Cell Transplantation is Warranted

Intervention: total lymphoid irradiation and anti-thymocyte globulin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Mohamad MOHTY, Pr, Principal Investigator, Affiliation: Hôpital Saint Antoine (AP-HP)

Overall contact:
Mohamad MOHTY, Pr, Phone: 01 49 28 26 20, Email: mohamad.mohty@inserm.fr

Summary

Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities associated with the transplant. Consequently non-relapse mortality has been reduced, including in elderly patients with comorbidities. However, despite this benefit in terms of toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal and viral infections are always serious complications. The aim of our study is to check if a new modality of reduced intensity preparative regimen combining total lymphoid irradiation (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the incidence of acute GVHD after allogeneic transplantation while preserving the antitumor benefit.

Clinical Details

Official title: 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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Neutrophil and platelets recovery and chimerism measurement

T cell subsets, regulatory cells, NK cells and B cells measurement

Number of relapse, acute and chronic GVHD

Eligibility

Minimum age: 50 Years. Maximum age: 66 Years. Gender(s): Both.

Criteria:

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 filtration 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.

Locations and Contacts

Mohamad MOHTY, Pr, Phone: 01 49 28 26 20, Email: mohamad.mohty@inserm.fr

Besançon University Hospital, Besançon, France; Recruiting
Eric DECONINCK, Pr, Phone: 03 81 66 82 32, Email: edeconinck@chu-besancon.fr
Eric DECONINCK, Pr, Principal Investigator

Bordeaux University Hospital, Bordeaux, France; Not yet recruiting
Noël MILPIED, Pr, Phone: 05 57 65 60 53, Email: noel.milpied@chu-bordeaux.fr
Noël MILPIED, Pr, Principal Investigator

Caen University Hospital, Caen, France; Recruiting
REMAN, Dr, Phone: 02 31 27 26 39, Email: reman-o@chu-caen.fr
REMAN, Dr, Principal Investigator

Clermont-Ferrand University Hospital, Clermont-Ferrand, France; Recruiting
Jacques-Olivier BAY, Pr, Phone: 04 73 75 00 65, Email: jobay@chu-clermontferrand.fr
Jacques-Olivier BAY, Pr, Principal Investigator

Lille University Hospital, Lille, France; Recruiting
Ibrahim YACOUB-AGHA, Pr, Phone: 03 20 44 55 51, Email: i-yakoub-agha@chru-lille.fr
Ibrahim YACOUB-AGHA, Pr, Principal Investigator

Lyon University Hospital, Lyon, France; Recruiting
Mauricette MICHALLET, Pr, Phone: 04 72 11 74 02, Email: mauricette.michallet@chu-lyon.fr
Mauricette MICHALLET, Pr, Principal Investigator

Nantes University Hospital, Nantes, France; Recruiting
Patrice CHEVALLIER, Dr, Email: patrice.chevallier@chu-nantes.fr
Patrice CHEVALLIER, Dr, Principal Investigator

Hôpital Saint Antoine, Paris 75571, France; Recruiting
RUBIO Marie-Thérèse, Dr, Phone: 01 49 28 26 20
Marie-Thérèse RUBIO, Dr, Principal Investigator

Additional Information

Starting date: March 2012
Last updated: February 10, 2015

Page last updated: August 20, 2015

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