search
Back to results

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

Primary Purpose

Hematologic Malignancies

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancies focused on measuring hematologic malignancies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • UCSD Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cyclophosphamide post BMT

Arm Description

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

Outcomes

Primary Outcome Measures

The primary endpoint is overall survival at 180 days from the time of transplantation.
180 days after transplantation

Secondary Outcome Measures

Incidence of Neutrophil Engraftment
incidence of neutrophil engraftment at Day 180

Full Information

First Posted
August 29, 2013
Last Updated
July 20, 2022
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT02623439
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Suspended
Why Stopped
On hold for toxicitiy
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
hematologic malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cyclophosphamide post BMT
Arm Type
Experimental
Arm Description
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Intervention Description
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Primary Outcome Measure Information:
Title
The primary endpoint is overall survival at 180 days from the time of transplantation.
Description
180 days after transplantation
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
Incidence of Neutrophil Engraftment
Description
incidence of neutrophil engraftment at Day 180
Time Frame
180 days post transplant day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Ku, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs