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

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ClinicalTrials.gov Identifier: NCT02623439
Recruitment Status : Suspended (On hold for toxicitiy)
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Grace Ku, MD, 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.

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : July 2012
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The primary endpoint is overall survival at 180 days from the time of transplantation. [ Time Frame: Day 180 ]
    180 days after transplantation


Secondary Outcome Measures :
  1. Incidence of Neutrophil Engraftment [ Time Frame: 180 days post transplant day 0 ]
    incidence of neutrophil engraftment at Day 180



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623439


Locations
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United States, California
UCSD Medical Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Grace Ku, MD UCSD

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Responsible Party: Dr. Grace Ku, MD, Assistant Professor of Clinical Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02623439     History of Changes
Other Study ID Numbers: 120931
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Keywords provided by Dr. Grace Ku, MD, University of California, San Diego:
hematologic malignancies

Additional relevant MeSH terms:
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Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists