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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01315132
First received: March 11, 2011
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Hematological Malignancies
Leukemia
Lymphoma
Multiple Myeloma
Hodgkin's Disease
Device: Matched Sibling Allogeneic Transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Engraftment, immune reconstitution, GVHD [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: April 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315132

Contacts
Contact: Neal Flomenberg, MD 215-955-4367
Contact: Donna Zuccarello 215-955-6612

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Neal Flomenberg, MD    215-955-4367      
Contact: Donna Zuccarello    215-955-6612      
Principal Investigator: Neal Flomenberg, MD         
Principal Investigator: Dolores Grosso, DNP, CRNP         
Sub-Investigator: John L Wagner, MD         
Sub-Investigator: Joanne Filicko-O'Hara, MD         
Sub-Investigator: Matthew Carabasi, MD         
Sub-Investigator: Margaret Kasner, MD         
Sub-Investigator: William O'Hara, PharmD         
Sub-Investigator: Maria Werner-Wasik, MD         
Sub-Investigator: S. Onder Alpdogan, MD         
Sub-Investigator: Wenyin Shi, MD, PhD         
Sub-Investigator: Mark Weiss, MD         
Sub-Investigator: Beth Colombe, PhD         
Sub-Investigator: Ubaldo Martinez Outschoorn, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Neal Flomenberg, MD Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01315132     History of Changes
Other Study ID Numbers: 08D.85, 2007-61
Study First Received: March 11, 2011
Last Updated: September 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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:
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014