Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match

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Brief Title

Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match

Official Title

A Phase II Study Of Pooled Unrelated Donor Umbilical Cord Blood (UCB) Transplant For Patients With Hematologic Malignancies Needing Allogeneic Stem Cell Transplant But Do Not Have A Related HLA-Matched Donor

Brief Summary

      The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for
      unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also
      to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.
    

Detailed Description

      Hematopoietic stem cell (HSC) transplantation, using human HLA-matched sibling or unrelated
      bone marrow or peripheral blood stem cell donor, has been used successfully to treat patients
      with high-risk or relapsed hematologic malignancies. However, use of this therapy has been
      limited by availability of fully HLA-matched donors, despite the increasing size of unrelated
      donor registries. For those transplanted with unrelated donor marrow stem cells, increased
      HLA disparity adversely affects survival due to increased risks of severe acute and chronic
      graft-versus-host disease (GVHD) and opportunistic infection. Only young recipients are able
      to tolerate a single HLA-A, B, DRB1 mismatch in this setting (1-3). To potentially extend the
      donor pool, UCB has been used as an alternative source of HSC. Since the first unrelated
      donor UCB transplant in 1993, UCB transplants have been performed worldwide. It has been
      found to produce outcome comparable to those from matched unrelated HSC in patients with
      hematologic malignancies (4). It has been shown that cryopreserved unrelated UCB from 0 to 3
      HLA-A, B, DRB1-mismatched donors contains sufficient HSC to engraft most pediatrics and some
      adult patients (5-10). Unfortunately, the use of UCB transplant is limited by the small
      number of HSC in each of the cord blood unit. This is particularly a problem for adult
      patients. It is now possible to pool UBC so that adequate cell numbers are available for
      adult transplant (11). UBC is rapidly availability and has very low rate of contamination
      with herpes group viruses. UCB transplant results in a low incidence of both severe acute
      GVHD and extensive chronic GVHD, despite the use of grafts with substantial donor-recipient
      HLA disparity (5-10).

      The following conditioning regimens will be used, depending on the underlying hematologic
      malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan
      will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning
      regimen of BCNU, Etoposide, ARA-C and Melphalan will be used. GVHD prophylaxis of oral
      tacrolimus will be used, depending on the development of GVHD and the clinical conditions of
      the patients, tacrolimus may be tapered and discontinued by six months after transplant. The
      hematopoietic stem cells from the donors will be infused within 48-72 hours of completing the
      chemotherapy. The patients will receive supportive care as indicated including antibiotics,
      antivirals, antifungals, anti-seizure, anti-emetic medications and other medications as
      necessary. In addition patients will receive irradiated blood products for support as
      necessary.CMV negative recipient transplant will receive only CMV- blood products. Neutrophil
      engraftment will be defined as the day on which the ANC rises to > 500 cells/ml for two
      consecutive days. Platelet engraftment will be defined as the first day on which the platelet
      count rises to > 20,000/ml over a 7-day interval without transfusion support.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

evaluate the multi-lineage hematopoietic chimerism for unrelated UCB grafts pooled from two to three cord blood units

Secondary Outcome

 evaluate the antitumor responses of pooled UCB transplant

Condition

Acute Myelogenous Leukemia

Intervention

Busulfan

Study Arms / Comparison Groups

 Single Arm
Description:  The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1

Start Date

November 2011

Completion Date

November 2013

Primary Completion Date

November 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Patients < 65 years with hematologic malignancies needing stem cell transplant but do
             not have HLA-matched sibling donor. Patients with the following diagnosis will be
             included:

               -  AML in first or subsequent complete or partial remissions

               -  ALL in first or subsequent complete or partial remissions

               -  CLL in second remission or more advanced disease

               -  CML who has failed tyrosine kinase inhibitors

               -  Hodgkin's disease who relapse after autologous transplant

               -  Non-Hodgkin's lymphoma who relapse after autologous transplant or NK-cell
                  lymphoma in CR1

               -  Aplastic anemia patients

               -  Multiple myeloma in second remission or moer advanced disease, including those
                  who have failed an autologous transplant

               -  Myelodysplastic syndrome in first or subsequent complete or partial remission

          -  Patients must have 6/6, 5/6 or 4/6 molecular matches from unrelated UCB donors.
             Matching will be done for A, B, and DR. Matching at DR will be confirmed by molecular
             typing.

          -  Patients must be documented to be HIV negative. Screening must have been performed
             within previous 6 months.

          -  Patients must be able to give written consent.

        Exclusion Criteria:

          -  Patient is excluded if all of the Inclusion criteria above isn't met.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Seah Lim, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01500161

Organization ID

1127920


Responsible Party

Principal Investigator

Study Sponsor

Texas Oncology Cancer Center


Study Sponsor

Seah Lim, MD, Principal Investigator, Texas Oncology - Amarillo,TX


Verification Date

November 2013