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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01315132
Recruitment Status : Recruiting
First Posted : March 15, 2011
Last Update Posted : November 13, 2017
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : January 2021

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. Overall Survival [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Engraftment, immune reconstitution, GVHD [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT01315132

Contact: Neal Flomenberg, MD 215-955-4367

United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Neal Flomenberg, MD    215-955-4367      
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
Sidney Kimmel Cancer Center at Thomas Jefferson University
Principal Investigator: Neal Flomenberg, MD Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University Identifier: NCT01315132     History of Changes
Other Study ID Numbers: 08D.85
2007-61 ( Other Identifier: CCRRC )
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

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
multiple myeloma
Hodgkin's Disease

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Hodgkin Disease
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists