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

Phase 2

Suspended

• Conditions: Hematologic Malignancies
• Interventions: Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant

• Registration Number: NCT02623439
• Lead Sponsor: University of California, San Diego

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).

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-07
• Status Verified: 2022-07
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cyclophosphamide post BMT	Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant	Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of Neutrophil Engraftment	180 days post transplant day 0	incidence of neutrophil engraftment at Day 180

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 La Jolla, California, United States