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A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01315132
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Leukemia Lymphoma Multiple Myeloma Hodgkin's Disease Device: Matched Sibling Allogeneic Transplantation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies
Actual Study Start Date : April 10, 2008
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : August 29, 2019


Arm Intervention/treatment
Experimental: Allogeneic Transplantation
Matched Sibling Allogeneic Transplantation
Device: Matched Sibling Allogeneic Transplantation
Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization
Other Name: CliniMACS




Primary Outcome Measures :
  1. Number of Patients With Overall Survival [ Time Frame: 1 Year after transplant ]
    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 :
  1. Graft Versus Host Disease (GVHD) [ Time Frame: 1 Year after transplant ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. 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:

    1. Age > 50 years
    2. ECOG Performance status of <2
    3. Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL
    4. CML 2nd chronic phase, accelerated phase, or blastic phase
    5. MDS with IPS of Intermediate 2 or greater
    6. Any myeloproliferative disorder
    7. Hodgkin lymphoma: relapsed, refractory, or primary induction failure
    8. Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT
    9. Other conditions not listed will be assessed as high-risk by the PI
  2. 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.
  3. Patients must adequate organ function:

    1. LVEF of >45%
    2. DLCO (adjusted for hemoglobin) >45% of predicted
    3. Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
    4. Creatinine clearance of > 60 ml/min
  4. Patients must be willing to use contraception if they have childbearing potential
  5. Able to give informed consent

Exclusion Criteria:

  1. ECOG performance status of 3 or 4.
  2. HIV positive
  3. Active involvement of the central nervous system with malignancy
  4. Psychiatric disorder that would preclude patients from signing an informed consent
  5. Pregnancy
  6. Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder.

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): NCT01315132


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Neal Flomenberg, MD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01315132    
Other Study ID Numbers: 08D.85
2007-61 ( Other Identifier: CCRRC )
First Posted: March 15, 2011    Key Record Dates
Results First Posted: October 15, 2019
Last Update Posted: October 15, 2019
Last Verified: September 2019
Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Myeloablative Hematopoietic Stem Cell Transplant
Cyclophosphamide tolerization
2 Step Approach
Hematological malignancies
leukemia
lymphoma
multiple myeloma
Hodgkin's Disease
Additional relevant MeSH terms:
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Multiple Myeloma
Hematologic Neoplasms
Hodgkin Disease
Neoplasms
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neoplasms by Site