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

Hematologic Malignancies Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02623439
• Other study ID #: 120931
• Status: Suspended
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: July 2022

Study information

• Verified date: July 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

Drug:
• Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant

Locations

Country	Name	City	State
United States	UCSD Medical Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is overall survival at 180 days from the time of transplantation.	180 days after transplantation	Day 180
Secondary	Incidence of Neutrophil Engraftment	incidence of neutrophil engraftment at Day 180	180 days post transplant day 0