Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-01-17 @ 11:18 AM
Study NCT ID:
NCT01786018
Status:
UNKNOWN
Last Update Posted:
2014-07-08
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas
Sponsor:
Azienda Ospedaliera San Giovanni Battista
Organization:
Study Overview
Official Title:
Allogeneic Transplantation After a Conditioning With Thiotepa, Busulfan and Fludarabin for the Treatment of Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas: a Phase II Multi-Center Trial
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TBF
Brief Summary:
The purpose of this study is to evaluate progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.
Detailed Description:
In the present study, it is hypothesised that patients with aggressive B cell lymphomas refractory to or relapsed early (within 12 months) after the completion of standard first-line immunoProtocol TBF2012 Version 1, 20 Nov 2012 9 chemotherapy can benefit from de-bulking salvage therapy (i.e. R-DHAP + bortezomib) followed by an allograft to improve progression-free survival.
Patient inclusion criteria
* Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
* Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
* Patients younger than 65 years old
* A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
* Patient must be competent to give consent
Patient exclusion criteria
* Patients treated with an autologous transplant as salvage therapy
* Patients with progressive lymphomas despite conventional therapies
* Patients with progressive lymphomas despite conventional therapies
* Uncontrolled CNS involvement with disease
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Females who are pregnant or breastfeeding
* Organ dysfunction defined as follows:
* Cardiac function: ejection fraction \<30% or uncontrolled cardiac failure
* Pulmonary: DLCO \<40% predicted
* Liver function abnormalities: elevation of bilirubin to \> 3 mg/dl and/or transaminases \>4 the upper limit of normal
* Renal: creatinine clearance \<50 cc/min (24 hour urine Protocol TBF2012 Version 1, 20 Nov 2012 6 collection)
* Karnofsky performance score \< 60%
* Patients with poorly controlled hypertension despite multiple antihypertensives
* Documented fungal disease that is progressive despite treatment
* Viral infections: HIV positive patients.
* Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
* Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
* Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
* Patients with active non-hematologic malignancies (except nonmelanoma skin cancers).
* Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \>20% risk of disease recurrence. Donor inclusion criteria:
* Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
* No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
* Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
* Age \< 18 years.
* Identical twin.
* Pregnancy.
* Infection with HIV.
* Inability to achieve adequate venous access.
* Known allergy to filgrastin (G-CSF).
* Current serious systemic illness.
Donor inclusion criteria:
* Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
* No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
* Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
* Age \< 18 years.
* Identical twin.
* Pregnancy.
* Infection with HIV.
* Inability to achieve adequate venous access.
* Known allergy to filgrastin (G-CSF).
* Current serious systemic illness.
Donor inclusion criteria:
* Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
* No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
* Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
* Age \< 18 years.
* Identical twin.
* Pregnancy.
* Infection with HIV.
* Inability to achieve adequate venous access.
* Known allergy to filgrastin (G-CSF).
* Current serious systemic illness.
Patient inclusion criteria
* Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
* Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
* Patients younger than 65 years old
* A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
* Patient must be competent to give consent
Patient exclusion criteria
* Patients treated with an autologous transplant as salvage therapy
* Patients with progressive lymphomas despite conventional therapies
* Patients with progressive lymphomas despite conventional therapies
* Uncontrolled CNS involvement with disease
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Females who are pregnant or breastfeeding
* Organ dysfunction defined as follows:
* Cardiac function: ejection fraction \<30% or uncontrolled cardiac failure
* Pulmonary: DLCO \<40% predicted
* Liver function abnormalities: elevation of bilirubin to \> 3 mg/dl and/or transaminases \>4 the upper limit of normal
* Renal: creatinine clearance \<50 cc/min (24 hour urine Protocol TBF2012 Version 1, 20 Nov 2012 6 collection)
* Karnofsky performance score \< 60%
* Patients with poorly controlled hypertension despite multiple antihypertensives
* Documented fungal disease that is progressive despite treatment
* Viral infections: HIV positive patients.
* Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
* Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
* Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
* Patients with active non-hematologic malignancies (except nonmelanoma skin cancers).
* Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \>20% risk of disease recurrence. Donor inclusion criteria:
* Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
* No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
* Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
* Age \< 18 years.
* Identical twin.
* Pregnancy.
* Infection with HIV.
* Inability to achieve adequate venous access.
* Known allergy to filgrastin (G-CSF).
* Current serious systemic illness.
Donor inclusion criteria:
* Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
* No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
* Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
* Age \< 18 years.
* Identical twin.
* Pregnancy.
* Infection with HIV.
* Inability to achieve adequate venous access.
* Known allergy to filgrastin (G-CSF).
* Current serious systemic illness.
Donor inclusion criteria:
* Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
* No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
* Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
* Age \< 18 years.
* Identical twin.
* Pregnancy.
* Infection with HIV.
* Inability to achieve adequate venous access.
* Known allergy to filgrastin (G-CSF).
* Current serious systemic illness.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: