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Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Relapsed Follicular Lymphoma

NCT01208896

CompletedPhase 2

Sponsor: University Hospital, Bordeaux

Conditions: Lymphoma, Follicular, Stem Cell Transplantation

Interventions: Reduced_intensity conditioning

Countries: France

This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell transplantation including Rituximab in the conditioning regimen for the treatment of relapsed follicular lymphoma. The rationale for using Rituximab relies on a better control of the disease and a better prophylaxis of the graft versus host disease.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Follicular lymphoma confirmed by a biopsy at the last relapse.
* 2nd, 3rd or 4th complete or partial response according to Cheson's criteria 1 (Annexe 1)
* Relapse after autologous-SCT except if the absence of autologous SCT is due to a failure of collecting peripheral stem cells or investigator decision to not proceed to the autologous graft because of serious criteria
* Relapse after at least one line of treatment with rituximab
* Karnofsky index \> 70%
* HLA Matched related or unrelated donor (10/10 matching; HLA-A, HLA-B, HLA-C, HLA-DRB1, HLA-DQB1)
* Signed informed consent

Exclusion Criteria:

* Stable or progressive disease according to Cheson's criteria1 (Annexe 1)
* Absence of treatment with rituximab before the last relapse
* Cardiac insufficiency (ejection fraction \< 50% by echocardiography)
* Pulmonary disease characterized by DLCO \< 60%
* Renal insufficiency (clearance of creatinin \< 60 ml/min)
* Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin \> 2 times the upper normal value except in case of Gilbert's disease or hepatic lymphoma
* HIV positive test
* Bacterial, Viral or Fungal uncontrolled infections
* Pregnant or breast feeding woman
* Cancer in the last 5 years except in case of cutaneous baso-cellular cancer or epithelioma "in situ" of the uterine cervix

Locations (26)

Angers, Angers, France
Besançon, France
Brest, France
Caen, France
Clermont-Ferrand, France
Grenoble, France
Lille, France
Limoges, France
Lyon, France
Montpellier, France
Nancy, France
Nantes, France
Nice, France
Paris, France
Paris, France
Paris, France
Paris, France
Pessac, France
Poitiers, France
Rennes, France
Rouen, France
Saint-Etienne, France
Strasbourg, France
Toulouse, France
Tours, France
Villejuif, France