Back to resultsA Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
Primary Purpose
Hematological Malignancies, Leukemia, Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Matched Sibling Allogeneic Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancies focused on measuring Myeloablative Hematopoietic Stem Cell Transplant, Cyclophosphamide tolerization, 2 Step Approach, Hematological malignancies, leukemia, lymphoma, multiple myeloma, Hodgkin's Disease
Eligibility Criteria
Inclusion Criteria:
Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:
- Age > 50 years
- ECOG Performance status of <2
- Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL
- CML 2nd chronic phase, accelerated phase, or blastic phase
- MDS with IPS of Intermediate 2 or greater
- Any myeloproliferative disorder
- Hodgkin lymphoma: relapsed, refractory, or primary induction failure
- Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT
- Other conditions not listed will be assessed as high-risk by the PI
- Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci.
Patients must adequate organ function:
- LVEF of >45%
- DLCO (adjusted for hemoglobin) >45% of predicted
- Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
- Creatinine clearance of > 60 ml/min
- Patients must be willing to use contraception if they have childbearing potential
- Able to give informed consent
Exclusion Criteria:
- ECOG performance status of 3 or 4.
- HIV positive
- Active involvement of the central nervous system with malignancy
- Psychiatric disorder that would preclude patients from signing an informed consent
- Pregnancy
- Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder.
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogeneic Transplantation
Arm Description
Matched Sibling Allogeneic Transplantation
Outcomes
Primary Outcome Measures
Number of Patients With Overall Survival
The primary objective of this prospective, phase II trial was to obtain an OS rate of >60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The >60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.
Secondary Outcome Measures
Graft Versus Host Disease (GVHD)
Full Information
NCT ID
NCT01315132
First Posted
March 11, 2011
Last Updated
September 27, 2019
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT01315132
Brief Title
A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
Official Title
A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2008 (Actual)
Primary Completion Date
September 19, 2018 (Actual)
Study Completion Date
August 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.
Detailed Description
This research protocol has been developed for patients undergoing matched-sibling hematopoietic stem cell transplant (HSCT). The patients who are treated according to this 2 step allogeneic HSCT protocol will receive cyclophosphamide to induce in-vivo tolerization of both autologous and allogeneic lymphocytes, followed by an allogeneic CD34-selected HSCT. The primary research questions relate to immune reconstitution, incidence of GVHD, and relapse in patients who receive lymphocyte treatment of this type in allogeneic HSCT and how it impacts overall survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies, Leukemia, Lymphoma, Multiple Myeloma, Hodgkin's Disease
Keywords
Myeloablative Hematopoietic Stem Cell Transplant, Cyclophosphamide tolerization, 2 Step Approach, Hematological malignancies, leukemia, lymphoma, multiple myeloma, Hodgkin's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic Transplantation
Arm Type
Experimental
Arm Description
Matched Sibling Allogeneic Transplantation
Intervention Type
Device
Intervention Name(s)
Matched Sibling Allogeneic Transplantation
Other Intervention Name(s)
CliniMACS
Intervention Description
Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization
Primary Outcome Measure Information:
Title
Number of Patients With Overall Survival
Description
The primary objective of this prospective, phase II trial was to obtain an OS rate of >60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The >60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.
Time Frame
1 Year after transplant
Secondary Outcome Measure Information:
Title
Graft Versus Host Disease (GVHD)
Time Frame
1 Year after transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:
Age > 50 years
ECOG Performance status of <2
Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL
CML 2nd chronic phase, accelerated phase, or blastic phase
MDS with IPS of Intermediate 2 or greater
Any myeloproliferative disorder
Hodgkin lymphoma: relapsed, refractory, or primary induction failure
Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT
Other conditions not listed will be assessed as high-risk by the PI
Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci.
Patients must adequate organ function:
LVEF of >45%
DLCO (adjusted for hemoglobin) >45% of predicted
Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
Creatinine clearance of > 60 ml/min
Patients must be willing to use contraception if they have childbearing potential
Able to give informed consent
Exclusion Criteria:
ECOG performance status of 3 or 4.
HIV positive
Active involvement of the central nervous system with malignancy
Psychiatric disorder that would preclude patients from signing an informed consent
Pregnancy
Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Flomenberg, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.JeffersonHospital.org
Description
Thomas Jefferson University Hospitals
Learn more about this trial
A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
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