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

NCT ID: NCT02623439

Last Updated: 2025-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-21

Study Completion Date

2023-01-01

Brief Summary

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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

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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).

Conditions

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Hematologic Malignancies

Keywords

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hematologic malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cyclophosphamide post BMT

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Caitlin Costello, MD

Assistant Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caitlin Caitlin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UCSD Medical Center

La Jolla, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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120931

Identifier Type: -

Identifier Source: org_study_id