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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Suspended
• CT.gov ID: NCT02623439
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 120
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2012
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cyclophosphamide post BMT Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant	Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant; Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant

Outcome Measures

Primary Outcome Measures

1. The primary endpoint is overall survival at 180 days from the time of transplantation. [Day 180]

   180 days after transplantation

Secondary Outcome Measures

1. Incidence of Neutrophil Engraftment [180 days post transplant day 0]

   incidence of neutrophil engraftment at Day 180

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. Burkitt's lymphoma: second or subsequent Complete Response (CR).

2. Lymphoma

3. Patients with adequate physical function

4. Performance status: Karnofsky score 70-100%.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Medical Center	La Jolla	California	United States	92093

Sponsors and Collaborators

• University of California, San Diego

Investigators

• Principal Investigator: Grace Ku, MD, UCSD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carolyn Mulroney, Associate Professor of Clinical Medicine, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT02623439
• Other Study ID Numbers: 120931
• First Posted: Dec 7, 2015
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Carolyn Mulroney, Associate Professor of Clinical Medicine, University of California, San Diego: hematologic malignancies
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms; Cyclophosphamide

Study Results

No Results Posted as of Jul 21, 2022