Clinical trial NCT02623439: A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Hematologic Malignancies
Keywords: hematologic malignancies
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

1. Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission.
2. Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma.
3. Myelodysplastic Syndrome (MDS)
4. 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).

Eligibility criteria: Inclusion Criteria:

1. Age: Subjects 18-70 years old.
2. Donor must be 18 years of age.
3. HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required.
4. Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
5. 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).
6. Burkitt's lymphoma: second or subsequent Complete Response (CR).
7. Lymphoma
8. Patients with adequate physical function
9. Performance status: Karnofsky score 70-100%.

Exclusion Criteria:

Primary outcomes:
measure: The primary endpoint is overall survival at 180 days from the time of transplantation.
timeFrame: Day 180
Secondary outcomes:
measure: Incidence of Neutrophil Engraftment
timeFrame: 180 days post transplant day 0
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: UCSD
name: Grace Ku, MD
role: PRINCIPAL_INVESTIGATOR
References: