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Safety and Efficacy of a Strategy of Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Chemosensitive Relapsed Follicular Lymphoma

Phase 2
18 Years
65 Years
Open (Enrolling)
Lymphoma, Follicular, Stem Cell Transplantation

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Trial Information

Safety and Efficacy of a Strategy of Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Chemosensitive Relapsed Follicular Lymphoma

Follicular lymphomas are chemosensitive neoplasms characterized by a relentless succession
of remissions and relapses when treated with conventional chemotherapy. The successive
periods of remission are of shorter duration and patients invariably die of their disease.
At first line, patients are treated with conventional chemotherapy. At first relapse,
intensive chemotherapy with autologous stem cell transplantation (SCT) is often proposed.

Allogeneic hematopoietic stem cell transplantation after reduced-intensity conditioning
(RIC-allo) is an option for patients relapsing after autologous SCT, allowing long-term
progression free survival of 50 to 60%. The toxic mortality related to severe acute graft
versus host disease (GVHD) remains a critical issue. The goal of our study is to test in a
multicentric approach a strategy of RIC-allo including rituximab in order to reduce the
incidence of acute GVHD.

Around half of patients with relapsed or refractory follicular lymphomas treated with
allogeneic SCT achieve long-term progression free survival whatever the conditioning
regimen. Because the median age of patients with follicular lymphoma is 55 years, a reduced
intensity conditioning is the most appropriate option in this setting. The outcome of
patients with a chemoresistant disease is usually poor because of a high toxic mortality. As
a consequence, only patients with a chemosensitive disease will be included in this study.
To further reduce the toxic mortality, it is critical to reduce the incidence of severe
acute GVHD. A low incidence of acute GVHD could be obtained by the use of Rituximab before
and after the transplantation as reported by the MD Anderson's experience in several
hematological malignancies including follicular lymphoma. Their results are impressive in
patients with follicular lymphoma with long-term survival of 85%. The favored hypothesis is
a depletion of patient and donor B cells reducing the presentation of minor
histocompatibility alloantigens. The benefit of Rituximab could also be explained by its
anti-lymphoma effects that could compensate the putative reduction of a graft versus
lymphoma effect due to a better control of GVHD.

The primary objective is to estimate 2-year overall survival in this setting.

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

- Relapse after autologous-SCT except if the absence of autologous SCT is due to a
failure of collecting peripheral stem cells

- 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,

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

2 year

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux


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

Study ID:

CHUBX 2009/09



Start Date:

February 2011

Completion Date:

October 2015

Related Keywords:

  • Lymphoma, Follicular
  • Stem Cell Transplantation
  • Allogeneic hematopoietic stem cell transplantation
  • Reduced-intensity conditioning
  • Chemosensitive relapsed follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular