Umbilical Cord Blood Transplantation From Unrelated Donors

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Brief Title

Umbilical Cord Blood Transplantation From Unrelated Donors

Official Title

Umbilical Cord Blood Transplantation From Unrelated Donors

Brief Summary

      This study is a single-center, treatment protocol with 4 possible preparative regimens,
      designed to validate the process of umbilical cord blood stem cell transplantation at our
      institution.
    

Detailed Description

      This study is a single-center treatment protocol with four possible preparative regimens,
      designed to validate the process of umbilical cord blood stem cell transplantation at our
      institution. Enrolled patients will receive chemotherapy +/-total body radiation as a
      pre-transplant conditioning regimen. Patients will then receive cord blood stem cells
      followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate Mofetil, or
      Cyclosporin A and Methylprednisolone. Multiple data points will be collected prior to,
      during, and following transplantation to ensure safety of the process and to evaluate the
      stated objectives.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Engraftment of ANC and Platelets

Secondary Outcome

 Rate of non-engraftment and of secondary graft failure

Condition

Acute Leukemia

Intervention

Total Body Irradiation 1200 cGy

Study Arms / Comparison Groups

 Full Intensity, TBI-based Conditioning
Description:  Full Intensity TBI-based Conditioning Total Body Irradiation 1200 cGy in fractions of 150 cGy days -8 or -7 to -4 Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: TBI/Cy

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

Radiation

Estimated Enrollment

30

Start Date

June 2015

Completion Date

June 2026

Primary Completion Date

June 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy
             with hematopoietic stem cell transplantation. Diagnoses include, but are not limited
             to:

          -  Congenital and Other Non-malignant Disorders:

          -  Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich
             Syndrome)

          -  Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital
             Osteopetrosis, Osteogenesis Imperfecta)

          -  Metabolic disorders (e.g. Hurler's Syndrome)

          -  Severe aplastic anemia

          -  High-Risk Leukemia:

          -  Acute Myelogenous Leukemia

          -  Refractory to standard induction therapy (more than 1 cycle required to achieve
             remission)

               -  Recurrent (in CR ≥ 2)

               -  Treatment-related AML or MDS

               -  Evolved from myelodysplastic syndrome

               -  Presence of FLT3 abnormalities

               -  FAB M6 or M7

               -  Adverse cytogenetics

               -  Myelodysplastic Syndrome

               -  Acute Lymphoblastic Leukemia including T lymphoblastic leukemia:

               -  Refractory to standard induction therapy (time to CR >4 weeks)

               -  Recurrent (in CR ≥ 2)

               -  WBC count >30,000/mcL at diagnosis

               -  Age >30 at diagnosis

          -  Adverse cytogenetics, such as t(9:22), t(1:19), t(4:11), and other MLL rearrangements.

          -  Chronic Myelogenous Leukemia in accelerated phase or blast crisis

          -  Biphenotypic or undifferentiated leukemia

          -  Burkitt's leukemia or lymphoma

          -  Lymphoma:

          -  Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemo-sensitive,
             and ineligible for an autologous stem cell transplant or previously treated with
             autologous SCT

          -  Marginal zone or follicular lymphoma that is progressive after at least two prior
             therapies

          -  Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or
             ineligible for an autologous HSCT

          -  Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease
             and disease status

          -  Adequate organ function:

          -  Cardiac - LVEF >45%, or shortening fraction >25%, Absence of congestive heart failure
             or conduction disturbances with high risk for sudden death

          -  Pulmonary - DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted;

          -  Renal - serum Cr < 1.5 times the upper limit of normal for age or GFR ≥ 50
             ml/min/1.73m2

          -  Hepatic - total bilirubin level < 2 times the upper limit of normal (except for
             patients with Gilbert's syndrome or hemolysis); if the primary disease process is
             causal, this criterion will be reconsidered. ALT, AST, and Alkaline phosphatase ≤ 5
             times upper limit of normal.

          -  Performance Status Karnofsky or Lansky score ≥ 70%.

          -  Informed Consent must be obtained prior to initiating conditioning therapy.

          -  Receipt of viable cord blood product(s), single or dual, must be confirmed with the
             stem cell processing laboratory prior to initiating conditioning therapy.

        Exclusion Criteria:

          -  Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a
             reasonable timeframe dictated by the clinical urgency of the transplant

          -  Autologous HSCT < 6 months prior to proposed UCB transplant

          -  Pregnant or breast feeding

          -  Current uncontrolled infection

          -  Evidence of HIV infection or positive HIV serology
      

Gender

All

Ages

2 Months - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jane L Liesveld, MD, 585-275-4099, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03016806

Organization ID

UBMT 15029


Responsible Party

Principal Investigator

Study Sponsor

University of Rochester


Study Sponsor

Jane L Liesveld, MD, Principal Investigator, Medical Director, Blood & Marrow Transplant Unit


Verification Date

May 2021