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Phase II study to evaluate the efficacy and safety of the association of Mozobil and growth factor in order to increase the capacity for mobilization of stem cells in peripheral blood to perform autologous stem cells, for patients suffering from lymphoma non-Hodgkin's diffuse large B-cell that we have not achieved a complete remission or relapsed / refractory after one or two therapeutic lines

A PHASE II STUDY OF CHEMOTHERAPY, MOZOBIL AND G-CSF AS MOBILIZING THERAPY FOR DOUBLE AUTOLOGOUS TRANSPLANTATION (ASCT) IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B CELL NON HODGKIN LYMPHOMA (DLBCL), PET POSITIVE AFTER TWO R-DHAP

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-024446-30-IT
Enrollment
Unknown
Registered
2012-06-15
Start date
2012-03-09
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DIFFUSE LARGE B CELL NON HODGKIN LYMPHOMA (DLBCL) MedDRA version: 14.1 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: MOZOBIL*SC 1FL 24MG 20MG/ML Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: PLERIXAFOR CAS Number: 110078-46-1 Current Sponsor code: AMD3100 Conce

Sponsors

AZIENDA OSPEDALIERA CARDINALE G.PANICO-TRICASE (LECCE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: DLBC non Hodgkin lymphoma not in CR after first line therapy, or in early relapse after first or second line chemotherapy or primary refractory to first line treatment . PET positivity at study entry and after the 2nd R-DHAP before the first ASCT Age: 18-65 y No Bone Marrow involvement DLCO, FEV1, FVC > 50% predicted LVEF greater than 45% HIV negative Non active HBV/HCV infection Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous ASCT High risk comorbidities for acute treatment complications Primary CNS DLBC non Hodgkin lymphoma Bone Marrow involvement Any active,uncontrolled infections Hypercalcemia Recent Cytokine administration ( peg-filgastrim in 21 d.), other cytokines in 7 d. before study entry Pregnant woman or not willing to use contraception

Design outcomes

Primary

MeasureTime frame
Main Objective: examine the efficacy and safety of Plerixafor in combination with G - CSF and chemotherapy, in order to collect an optimal number of peripheral blood HSC in patients with DLBC non Hodgkin lymphoma in order to perform a tandem ASCT.;Secondary Objective: Number of apheresis to reach the target of 6 x 106/kg CD34 Toxicity of the mobilization procedure Toxicity of double autologous Engrafment early and late overall Survival Disease free survival at six twelve months Progression-free survival at six twelve months;Primary end point(s): Assess the percentage of patients who reach the target value of CD34 positive> = 6 x 106/kg;Timepoint(s) of evaluation of this end point: 24 months.After treatment of the last patient enrolled—

Secondary

MeasureTime frame
Secondary end point(s): Number of apheresis to reach the target of 6 x 106/kg CD34 + cells;Timepoint(s) of evaluation of this end point: 24 months.After treatment of the last patient enrolled—

Countries

Italy

Contacts

Public ContactVincenzo Pavone

AZIENDA OSPEDALIERA CARDINALE G.PANICO-TRICASE (LECCE)

salentoematologia@piafondazionepanico.it0833/773111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026