Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea20 enrolled

Overview

To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkin Lymphoma

Interventions

Ibritumomab Tiuxetan (Zevalin)DRUG

Conditioning Regimen 1. Rituximab, 250 mg/m2 on days -21 and -14. 2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14. Chemotherapy: * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion. Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months: * Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8. * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent 2. Histologically confirmed B-cell lymphoma of the following subtypes: * LBCDL * Grade 3b follicular lymphoma * Mantle-cell lymphoma * Transformed B-cell lymphoma * Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant 3. High-risk B-cell CD20+ lymphoma defined by * Having attained less than PR after two chemotherapy lines * Post-transplantation relapse * Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation * Inability to collect enough stem cells for autologous transplantation 4. Stable disease at the time of transplantation 5. Age between 18 and 65 6. Performance status (ECOG) ≤ 2 7. Normal and suitable pulmonary function (DLCO ≥ 30%) 8. Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40% 9. Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration) Exclusion Criteria: 1. Prior treatment with radiopharmaceutical agents 2. HIV-associated lymphoma 3. Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA) 4. Patient's inability to follow the protocol 5. Hypersensitivity to 90Y-itritumomab tiuxetan 6. Presence of severe pathologies that preclude chemotherapeutic treatment 7. Pregnant women or pregnancy risk due to inappropriate contraceptive measures 8. Breastfeeding women

Locations (14)

H. Santa Creu i Sant Pau.

Barcelona, Barcelona., Spain

H. U. Marqués de Valdecilla.

Santander, Cantabria, Spain

H.U. 12 de Octubre

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

progression-free survival

Time frame: 12 months

Secondary Outcomes

safety (toxicity, transplantation- and graft-related mortality)

Time frame: 36 months

response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).

Time frame: 36 months

overall survival

Time frame: 36 months

relapse rate

Time frame: 36 months

acute and chronic Graft-versus-Host Disease

Time frame: 36 months

haematological and immunological reconstitution, and chimerism.

Time frame: Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.

the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival

Time frame: 36 months

Data from ClinicalTrials.gov

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