A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
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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 |
|---|---|---|
|
Hematologic Neoplasms Leukemia Lymphoma Multiple Myeloma Hodgkin's Disease |
Procedure: Matched Sibling Allogeneic Transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
- Overall Survival [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- 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 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Allogeneic Transplantation
Matched Sibling Allogeneic Transplantation
|
Procedure: Matched Sibling Allogeneic Transplantation
Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization
|
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 |
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.
Contacts and Locations| Contact: Neal Flomenberg, MD | 215-955-4367 | Neal.Flomenberg@jefferson.org |
| Contact: Donna Zuccarello | 215-955-6612 | Donna.Zuccarello@jeffersonhospital.org |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Neal Flomenberg, MD 215-955-4367 Neal.Flomenberg@jefferson.edu | |
| Contact: Donna Zuccarello 215-955-6612 Donna.Zuccarello@jeffersonhospital.org | |
| Principal Investigator: Neal Flomenberg, MD | |
| Sub-Investigator: Dolores Grosso, DNP, CRNP | |
| Sub-Investigator: John L Wagner, MD | |
| Sub-Investigator: Joanne Filicko-O'Hara, MD | |
| Principal Investigator: | Neal Flomenberg, MD | Thomas Jefferson University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Neal Flomenberg, MD, 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: | March 11, 2011 |
| 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:
|
Neoplasms Hodgkin Disease Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Hematologic Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Neoplasms by Site Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013