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

Phase 2

Recruiting

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

• Registration Number: ACTRN12617000151336
• Lead Sponsor: St Vincent's Hospital Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-27
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Patients 16 – 70 years of age

2. Recipients must have a haematological malignancy with a significant risk of relapse (as measured by the Disease Risk Index), where allogeneic transplant is indicated.

3. Adults without a readily available matched related or unrelated donor.

4. Patients must have a first-degree relative who are 3/6 to 4/6 HLA matched.

5. Patients with an HCT-CI/age > or equal to 3 will receive non-myeloablative conditioning.

6. Adequate cardiac (LVEF >50%), pulmonary (DLCO/VA >50%) and renal function (Creatinine Clearance >60ml/min).

7. Informed written consent.

8. Haematological malignancies may be (but are not limited to):
a. AMLCR1 (high risk cytogenetics, FLT-3 positive), CR2
b. AML refractory disease with less than or equal 2 CIBMTR adverse risk factors.
c. tAML/MDS: with less than or equal 2 CIBMTR adverse risk factors
d. MDSIPSS Int-2/High risk
e. MPD eligible for HSCT
f. CML prior AP/BT in CP2; inadequate response to treatment of CP CML:
g. ALL CR1 (high risk cytogenetics or MRD+ve), CR2
h. Lymphoma (NHL or HL) in remission

Exclusion Criteria

1.Pregnancy.

2. Positive serology for HIV.

3. Refractory Central Nervous System (CNS) disease.

4. Serious organ dysfunction: LVEF <50%, FEV1, FVC, DLCO <50%of predicted, LFT > 5 x the upper limit of normal, or creatinine clearance < 40 ml/min .

5. Life expectancy less than 60 days.

6. Unable or unwilling to provide written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified