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Closed (no longer recruiting)Last updated: 31 January 2024

This phase II trial is evaluating whether chemotherapy (cyclophosphamide) post-stem cell infusion will prevent Graft versus Host disease in blood cancer patients requiring a haplo-identical stem cell transplantA phase II study of haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide as Graft versus Host Disease (GVHD) prophylaxis

Clinical summary

Summary

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.

Conditions

This trial is treating patients with blood cancer.

Cancer

Blood Cancers Haematological

Age

People16 - 70

Phase

II

More information

Trial Identifiers

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Trial sponsor

St Vincents Hospital Sydney ,Arrow Bone Marrow Transplant Foundation

Scientific Title

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

Eligibility

Inclusion

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

 

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

Exclusion

  • You have certain types of non-cancer medical conditions.
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