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Trial Title: Reduced Intensity Conditioning (RIC) Regimen and Post-transplant Cyclophosphamide in Haploidentical Bone Marrow Transplantation in in Patients With Poor Prognosis Lymphomas

NCT ID: NCT02049580

Condition: Lymphoma

Conditions: Official terms:
Lymphoma
Cyclophosphamide
Thiotepa
Fludarabine

Conditions: Keywords:
lymphoma

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Thiotepa
Description: Thiotepa (10 mg/kg /day) will be administered every 12 h, at day -6
Arm group label: RIC regimen

Other name: Tepadina

Intervention type: Drug
Intervention name: Fludarabine
Description: Fludarabine (30mg/m2/day x 4 days) will be dosed according to renal function. For decreased creatinine clearance (CCr) (≤ 61 mL/min) Fludarabine dosage should be reduced as follows: CCr 46-60 mL/min, fludarabine = 24 mg/ m2/day
Arm group label: RIC regimen

Other name: Fludara

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: Pre-transplantation Cyclophosphamide(Cy) 30 mg/kg/day will be administered as a 1-2 hour intravenous infusion with a high volume fluid flush on Days -5. Cy will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the Adjusted IBW (AIBW) Cyclophosphamide [50 mg/kg/day IBW] will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume).
Arm group label: RIC regimen

Other name: Endoxan

Summary: Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis lymphomas.

Detailed description: Allogeneic stem cell transplantation (ALLO) is the treatment of choice for many hematological diseases. However, HLA identical donor (sibling or unrelated) is available for 50-60% of patients and alternative donors are needed. Haploidentical donors have been used for many years, mostly after extensive T-cell depletion of peripheral stem cell, to avoid Graft Versus Host Disease (GVHD). Recently, promising data have been reported with haploidentical transplantation using T-replete bone marrow (BM) and high-dose cyclophosphamide (Cy) post-transplantation. However, the conditioning regimen did not contain drugs active against hemopathies, enhancing the relapse risk. In this study, the investigators want to test the feasibility and efficacy of T-replete BM, infused after a RIC regimen and post-transplantation Cy, in patients with poor prognosis lymphoproliferative diseases. The RIC regimen consisted of modified regimen used in different studies conducted in Italy on behalf GITMO.

Criteria for eligibility:
Criteria:
- Signed and dated IEC-approved informed consent - Age ≥ 18-70 years old. - Performance Status Karnofsky ≥ 80% (see appendix B) - HLA typing will be performed at high resolution (allele level) for the HLA-A, HLA -B, HLA Cw, HLA-DRB1, and HLA-DQB1 loci. A minimum match of 5/10 is required. An unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant. - The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. - Patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last CT line. 1. Hodgkin's lymphoma: Patients refractory to at least 2 CT lines, and included in tandem auto-allo program 2. Diffuse large B cell lymphoma: Refractory to second line salvage chemotherapy (patients in partial remission, stable disease or progressive). These patients have to be in partial remission, complete remission or stable disease after one o more further CT line. 3. Peripheral T cell lymphoma: Patients failing to achieve a complete remission after first line CT. 4. Low grade lymphomas (follicular and non follicular: Patients refractory to rituximab containing regimens. Patients relapsing after at least 2 lines CT. The duration of remission should be < 1 year. 5. Chronic lymphatic leukemia: Patients with refractory or relapsing (response duration < 1 year) disease after R-Fludarabine CT 6. Mantle cell lymphoma: Patients relapsing or refractory after first line conventional CT. - Absence of HLA identical sibling and 10/10 unrelated donor - Patients with adequate physical function as measured by: Cardiac: Left ventricular ejection fraction at rest must be ≥ 40% Hepatic: Bilirubin ≤ 2.5 mg/dL; and ALT, AST, and Alkaline Phosphatase ≤ 5 x ULN. Renal: Creatinine clearance or GFR ≥ 50 mL/min/1.73 m2. Pulmonary: FEV1, FVC, DLCO ≥ 50% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation ≥ 92% on room air. Exclusion Criteria: - Presence of HLA-matched, related donor (HLA-A, -B, -DRB1) - Presence of matched unrelated donor (10/10), available on time. - Pregnancy or breast-feeding. - Evidence of HIV infection or known HIV positive serology. - Current uncontrolled bacterial, viral or fungal infection - Evidence of progression of clinical symptoms or radiologic findings. - Prior allogeneic hematopoietic stem cell transplant. - Central Nervous System (CNS) lymphoma localization

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Istituto Clinico Humanitas

Address:
City: Rozzano
Zip: 20089
Country: Italy

Status: Recruiting

Contact:
Last name: Luca Castagna, MD

Phone: +39028224

Phone ext: 4587
Email: luca.castagna@humanitas.it

Investigator:
Last name: Luca Castagna, MD
Email: Principal Investigator

Start date: July 2013

Completion date: November 2016

Lead sponsor:
Agency: Istituto Clinico Humanitas
Agency class: Other

Source: Istituto Clinico Humanitas

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02049580

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