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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas

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Trial Information

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

Inclusion Criteria


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 >4x the upper limit of normal

- Renal: creatinine clearance <50 cc/min (24 hour urine 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 non-melanoma 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 HLA-mismatched (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 mg/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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Benedetto Bruno, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Divisione di Ematologia-Città della Salute e della Scienza di Torino

Authority:

Italy: Ministry of Health

Study ID:

TBF2012

NCT ID:

NCT01786018

Start Date:

February 2013

Completion Date:

February 2015

Related Keywords:

  • Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas
  • Non Hodgkin lymphomas
  • Allogeneic Transplantation
  • Thiotepa
  • Busulfan
  • Fludarabin
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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