RecruitingPhase 2ACTRN12617000151336

A phase II study of haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide as Graft versus Host Disease (GVHD) prophylaxis

Sponsor

St Vincent's Hospital Sydney

Enrollment

70 participants

Start Date

Aug 27, 2015

Study Type

Interventional

Conditions

Non Hodgkin's Disease in remission Acute Myeloid Leukaemia in first or second complete remission acute Lymphoblastic Leukaemia in first or second complete remission Myeloproliferative disease Acute Myeloid Leukaemia refractory disease with less than or equal 2 CIBMTR Patient requiring a haplo-identical stem cell tranplant for Myelodysplastic syndrome with less than or equal 2 CIBMTR risk factors for Hodgkins Disease in remission MDSIPSS transformed Acute Myeloid Leukaemia with less than or equal 2 CIBMTR risk factors Chronic Myeloid Leukaemia prior to acute or blast transformation

Summary

This study will assess the use of cyclophosphamide post stem cell infusion as preventative treatment for Graft versus Host disease in patients requiring a haplo-identical stem cell transplant. Who is it for? You may be eligible to join this study if you are 16 – 70 years of age and have haematological malignancies requiring allogeneic transplantation, but have no readily available fully HLA-matched related or unrelated donors. Study details All patients will receive peripheral blood stem cell transplant from haploidentical relatives. Patients will either undergo myeloablative or non- myeloablative conditioning treatments prior to receiving stem cell transplants. The conditioning treatment selected is determined by the transplant specialist. Two groups will then receive a treatment aimed at prevention of Graft versus Host disease after stem cell transplant. If you receive myeloablative conditioning treatment, your post-transplant treatment will include cyclophosphamide 50mg/kg administered on day 3 and day 4 after transplant with cyclosporine [dose calculated on body weight] and mycophenolate [dose calculated on body weight ] commencing on day 5 after transplant. If you receive non- myeloablative conditioning treatment, your post-transplant treatment will include cyclophosphamide 50mg/kg administered on day 3 and day 4 after transplant with tacrolimus [dose calculated on body weight] and mycophenolate [dose calculated on body weight] commencing on day 5 after transplant. Total duration of treatment will depend if graft versus host diseas develops and how severe. It is anticiapted adding cyclophosphamide post stem cell infusion will prevent Graft versus Host disease or affect the rate of acute and chronic Graft versus Host disease

Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people with blood cancers (such as leukaemia or lymphoma) who need a stem cell transplant but do not have a perfectly matched donor. It uses a transplant from a half-matched family member (called a haploidentical transplant) and then uses a medication called cyclophosphamide shortly after the transplant to prevent the body from attacking the new cells (a complication called Graft versus Host Disease, or GVHD). You may be eligible if: - You are between 16 and 70 years old - You have a blood cancer (such as AML, MDS, ALL, CML, or lymphoma) that needs a transplant - You do not have a fully matched related or unrelated donor - You have a close family member who is a half-match (haploidentical) - Your heart, lungs, and kidneys are functioning adequately You may NOT be eligible if: - You are pregnant - You are HIV positive - Cancer has spread to the brain and is not responding to treatment - You have serious organ failure - Your life expectancy is less than 60 days - You cannot provide written consent Talk to your doctor about whether this trial might be right for you.

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Interventions

This study involves the use of cyclophosphamide post stem cell infusion as prophylactic treatment for Graft versus Host disease. Cyclophosphamide will be used in one of 2 available conditioning treatments; Non-myeloabative and Myeloablative conditioning treatment. The conditioning treatment selected is determined by the transplant specialist. Arm 1.Patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation using intravenous Fludarabine 40mg/m2 daily for 5 day from day -6 to day -2. Busulphan will be administered intravenously at a dose of 3.2mg/kg/day for 4 days from days -5 to day -2. Graft Versus Host Disease prophylaxis consisting of post-transplant intravenous cyclophosphamide 50mg/kg will be given for 2 days on Day +3 to day +4 with cyclosporin and mycophenolate commencing on D+5.. Cyclosporine at 1.5mg/kg given twice a day intravenously from Day +5 onwards until the patients has engrafted and is able to tolerate oral cyclosporine. The dose of oral cyclosporine will be re-assessed by their treating physician at Day +60. Mycophenolate mofetil at 15 mg/kg given three times per day taken oral tablet will be started on day +5. Cyclosporin and Mycophenolate will be stopped as directed per treating physician Arm 2. Patients undergoing non-myeloablative transplantation will receive intravenous Fludarabine 30 mg/m2 daily for 5 day from days -6 to day -2 with Intravenous cyclophosphamide 29 mg/kg, given daily for 2 days on day -6 to day -5 in combination with Total body irradiation 200cGy given once on day -1. Graft Versus Host Disease prophylaxis consisting of post- transplant intravenous cyclophosphamide 50mg/kg gien daily for 2 days on on Day +3 and Day +4, Tacrolimus tablets will be given orally in 2 divided doses daily to target blood levels of 5-15 ng/ml from day +5 and re-assessed at Day +60. Dose is determined by treating physician. Mycophenolate mofetil 15 mg/kg given three times per day taken oral tablet will be started on day +5. Tacrolimus and Mycophenolate will be stopped as directed per treating physician.

Locations(6)

Westmead Hospital - Westmead

NSW,VIC, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,VIC, Australia

Royal Melbourne Hospital - Royal Park campus - Parkville

NSW,VIC, Australia

Auckland, New Zealand

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ACTRN12617000151336