T CELL DEPLETED HEMATOPOIETIC STEM CELL TRANSPLANT POST REDUCED INTENSITY CONDITIONING AND EARLY USE OF CYCLOPHOPHAMIDE

A COMBINATION THERAPY COMPRISING A 'MEGADOSE' OF T CELL DEPLETED HEMATOPOIETIC STEM CELL TRANSPLANT POST-TRANSPLANT CYCLOPHOPHAMIDE AND A REDUCED INTENSITY CONDITIONING FOR A STABLE AND LONG TERM ENGRAFTMENT - T CELL DEPLETED HSCT, REDUCED INTENSITY CONDITIONING AND POST-TRANSPLANT CYCLOPHOPHAMIDE

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003628-35-IT

Enrollment

Registered

2013-09-19

Start date

2014-09-23

Completion date

Unknown

Last updated

2015-03-30

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

Conditions

None listed

Interventions

Trade Name: Endoxan Product Name: Ciclofosfamide Pharmaceutical Form: Powder for infusion INN or Proposed INN: cyclophosphamide CAS Number: 6055-19-2 Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age between 18 and 70; - Diagnosis according to the WHO classification: CLL patients with refractoriness to fludarabine or other chemotherapy due to the p53 loss by 17p deletion and/or TP53 mutation; Follicular lymphoma with either unfavourable cytogenetics such as complex karyotype, del17p, del 6q23-26, mutations in TP53, minus 1p; Hodgkin's Lymphoma relapsed after autologous transplantation, not elegible for immunotherapy with anti-CD30- Multiple myeloma relapsing after autologous transplantation, with unfavourable cytogenetics in either partial or complete remission. Non available matched unrelated donor.Availability of haploidentical family donor; patients has an Eastern Cooperative Oncology Group (ECOG) performance status = 2; understands and voluntarily signs an informed consent form, skilled in adhering to the study visit schedule and other protocol requirements; creatinine clearance 30 ml/min- Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: - age 70; - creatinine clearance >1,5 or GFR 2000 UI/mL is criteria of exclusion, Patient is HBsAg- HBsAb+ Patient is HBsAg- HBcAb+ Patients with HCV active hepatitis are excluded from the study, Psychiatric problems, Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Stable-donor type engraftment without any post-transplant immunosuppressive treatment;Secondary Objective: - incidence of estensive acute and chronic GVHD; - transplant related mortality (TRM), - immunologic reconstitution; - Myeloid and lymphoid chimerism ; -Overall survival and progression free survival;Primary end point(s): Donor-type engraftment will be evaluated by chimerism analysis;Timepoint(s) of evaluation of this end point: At least 9-12 months, to evaluate stable chimerism	—

Measure

Time frame

Main Objective: Stable-donor type engraftment without any post-transplant immunosuppressive treatment;Secondary Objective: - incidence of estensive acute and chronic GVHD; - transplant related mortality (TRM), - immunologic reconstitution; - Myeloid and lymphoid chimerism ; -Overall survival and progression free survival;Primary end point(s): Donor-type engraftment will be evaluated by chimerism analysis;Timepoint(s) of evaluation of this end point: At least 9-12 months, to evaluate stable chimerism

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Secondary

Measure	Time frame
Secondary end point(s): - Acute GVHD will be classified by IBMTR severity index; -Chronic GVHD will be identified according to NIH working group new global scoring system, -TRM is defined as all deaths occurred without previous relapse or progression; - Immunologic reconstitution post engraftment defined as time needed to reach and exceed 500 lymphocyte CD3+/mcL and 200 CD4+/mcL; - Myeloid and lymphoid chimerism; -Overall survival and event free survival ;Timepoint(s) of evaluation of this end point: 48 months	—

Measure

Time frame

Secondary end point(s): - Acute GVHD will be classified by IBMTR severity index; -Chronic GVHD will be identified according to NIH working group new global scoring system, -TRM is defined as all deaths occurred without previous relapse or progression; - Immunologic reconstitution post engraftment defined as time needed to reach and exceed 500 lymphocyte CD3+/mcL and 200 CD4+/mcL; - Myeloid and lymphoid chimerism; -Overall survival and event free survival ;Timepoint(s) of evaluation of this end point: 48 months

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Countries

Italy

Contacts

Public ContactGiulia De Luca

Segreteria Comitato Etico Parma

gideluca@ao.pr.it00390521704475

Outcome results