A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.

Detailed Description
-----------------
Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including: Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission. Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma. Myelodysplastic Syndrome (MDS) Blastic plasmacytoid dendritic cell neoplasm Primary Objective: The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis. Secondary Objectives: Secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic Graft versus Host Disease (GVHD), incidence of infections, and cumulative incidence of relapse/progression. The investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).

Official Title
-----------------
A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies

Conditions
-----------------
Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Subjects 18-70 years old. Donor must be 18 years of age. HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required. Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy). Acute Leukemias. Acute Lymphoblastic Leukemia in high risk 1st complete response (CR1) Acute Myelogenous Leukemia in high risk 1st complete response (CR1) Acute Leukemias in 2nd or subsequent Complete Response (CR) Biphenotypic/Undifferentiated Leukemias in 1st or subsequent Complete Response (CR). Burkitt's lymphoma: second or subsequent Complete Response (CR). Lymphoma Patients with adequate physical function Performance status: Karnofsky score 70-100%. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cyclophosphamide post BMT<br>Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant | Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant<br>* Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is overall survival at 180 days from the time of transplantation. | 180 days after transplantation | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Neutrophil Engraftment | incidence of neutrophil engraftment at Day 180 | 180 days post transplant day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hematologic malignancies