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Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cord Blood Transplant
Sponsored by
Colorado Blood Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Cord Blood Transplant, Umbilical cord blood transplant, Transplant, Fludarabine, Total Body Irradiation, Cyclophosphamide

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must: Be between the ages of 18 and 49 years inclusive. Have histologically proven hematologic malignancy and must meet accepted indications for allogeneic stem cell transplantation: Acute myeloid leukemia (AML): high-risk in first complete remission (CR), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission. Acute lymphoblastic leukemia with high-risk features in first remission (Philadelphia chromosome positive or other similar high-risk features), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission. Chronic myeloid leukemia: in chronic phase (CP) and have failed Gleevec or are intolerant and have signs of failing other treatments, or have history of accelerated or blast phases. Storage of autologous peripheral blood stem cells is recommended for this group for patients, particularly if in chronic phase. Non-Hodgkin's lymphoma: aggressive histology with relapsed or primary refractory disease and not eligible for autologous transplantation. Patients with low-grade histology must have either failed 2 or more lines of systemic chemotherapy including one rituximab-based regimen. Radioimmunotherapy will be considered the equivalent of one line of chemotherapy. Excluded if prior radiotherapy to chest or prior autologous transplantation. Myelodysplastic syndromes with International Prognostic Scoring System (IPSS) score of 1.5 or greater. Other hematological malignancies if approved by the pipeline meeting on a case by case basis. Must also be approved by principal investigator. Have no HLA-matched or 1-antigen mismatched related donors and no HLA-matched unrelated stem cell donors, or delays involved in performing a search are likely to be detrimental to the patient. Have an ECOG performance status of 0 or 1 at the time of transplant. Have major end organs (heart, lungs, liver, and kidneys) assessed and deemed adequate to withstand the effects of high-dose therapy planned for this protocol. Have given voluntary informed consent. Exclusion Criteria: Patients are ineligible for this protocol if they: Have a co-morbid medical condition, a psychiatric condition, or organ dysfunction that makes them at high-risk for treatment failure, for failed medical compliance, or for regimen-related toxicity from high-dose therapy. Patients with any of the following will be excluded: Pulmonary: hemoglobin (Hb)-adjusted diffusing capacity of lung for carbon monoxide (DLCO) < 60%, forced expiratory volume in 1 second (FEV1) < 70% of predicted, or receive continuous supplemental oxygen; Cardiac: left ventricular ejection fraction (LVEF) < 50% or on any treatment for congestive heart failure; Renal: serum creatinine greater than 2.0 or calculated creatinine clearance < 50 cc/min; Liver: ALT, AST, or serum bilirubin > 1.5 x upper limit of normal (ULN). Any patient with elevated transaminases should have careful evaluation for the cause and liver biopsy may be required by the principle investigator. An elevated alkaline phosphatase should be fractionated and, if of liver origin, should be evaluated as for transaminases. Are female and are pregnant, lactating, or have a positive pregnancy test. Have a history of previous malignancy except for non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for > 5 years Are HIV positive Refractory malignancy: acute leukemia with greater than 30% blasts in bone marrow unless with untreated first relapse of AML or untreated myelodysplastic syndrome evolved to AML. Acute leukemia with greater than 1000 blasts/ul in peripheral blood. Uncontrolled central nervous system (CNS) leukemia or lymphoma. Prior autologous or allogeneic transplantation using a myeloablative regimen. Uncontrolled hypertension (systolic blood pressure [SBP] > 140, diastolic blood pressure [DBP] > 90) or hypertension requiring > 2 drugs for good control (SBP < 130, DBP < 90). Invasive mold infection that is uncontrolled or has received less than one month of antifungal therapy.

Sites / Locations

  • Rocky Mountain Blood and Marrow Transplant ProgramRecruiting

Outcomes

Primary Outcome Measures

Evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units

Secondary Outcome Measures

Evaluate safety as measured by day 100 treatment related mortality
Evaluate incidence of platelet engraftment
Evaluate incidences of acute and chronic graft-versus-host disease (GVHD)
Evaluate efficacy as measured by survival at 1 and 2 years after transplant
Evaluate chimerism from double cord transplants to determine source of long term engraftment

Full Information

First Posted
May 17, 2006
Last Updated
June 23, 2006
Sponsor
Colorado Blood Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00328237
Brief Title
Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation
Official Title
Treatment of Hematologic Malignancies With High-Dose Chemo-Radiotherapy Followed by Single-Unit or Double-Unit Cord Blood Transplantation: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Colorado Blood Cancer Institute

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.
Detailed Description
This is a non-randomized, phase II protocol to evaluate engraftment of cord blood after treatment with myeloablative conditioning of fludarabine, total body irradiation and cyclophosphamide. All patients will receive tacrolimus and mycophenolate mofetil as prophylaxis for graft-vs-host disease. Conditioning Regimen: Days -10 to -7: Fludarabine 30mg/m2/day IV Days -7 to -4: TBI 165 centigray BID Days -3 to -2: Cyclophosphamide 40mg/kg/day IV Day 0: Infusion of Cord Blood Cells Graft-vs-Host Disease Prophylaxis Day -1: Start tacrolimus 0.03mg/kg/day IV Day 0: Start MMF 7.5mg/kg IV BID

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non-Hodgkin Lymphoma, Myelodysplastic Syndromes
Keywords
Cord Blood Transplant, Umbilical cord blood transplant, Transplant, Fludarabine, Total Body Irradiation, Cyclophosphamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Cord Blood Transplant
Primary Outcome Measure Information:
Title
Evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units
Secondary Outcome Measure Information:
Title
Evaluate safety as measured by day 100 treatment related mortality
Title
Evaluate incidence of platelet engraftment
Title
Evaluate incidences of acute and chronic graft-versus-host disease (GVHD)
Title
Evaluate efficacy as measured by survival at 1 and 2 years after transplant
Title
Evaluate chimerism from double cord transplants to determine source of long term engraftment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must: Be between the ages of 18 and 49 years inclusive. Have histologically proven hematologic malignancy and must meet accepted indications for allogeneic stem cell transplantation: Acute myeloid leukemia (AML): high-risk in first complete remission (CR), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission. Acute lymphoblastic leukemia with high-risk features in first remission (Philadelphia chromosome positive or other similar high-risk features), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission. Chronic myeloid leukemia: in chronic phase (CP) and have failed Gleevec or are intolerant and have signs of failing other treatments, or have history of accelerated or blast phases. Storage of autologous peripheral blood stem cells is recommended for this group for patients, particularly if in chronic phase. Non-Hodgkin's lymphoma: aggressive histology with relapsed or primary refractory disease and not eligible for autologous transplantation. Patients with low-grade histology must have either failed 2 or more lines of systemic chemotherapy including one rituximab-based regimen. Radioimmunotherapy will be considered the equivalent of one line of chemotherapy. Excluded if prior radiotherapy to chest or prior autologous transplantation. Myelodysplastic syndromes with International Prognostic Scoring System (IPSS) score of 1.5 or greater. Other hematological malignancies if approved by the pipeline meeting on a case by case basis. Must also be approved by principal investigator. Have no HLA-matched or 1-antigen mismatched related donors and no HLA-matched unrelated stem cell donors, or delays involved in performing a search are likely to be detrimental to the patient. Have an ECOG performance status of 0 or 1 at the time of transplant. Have major end organs (heart, lungs, liver, and kidneys) assessed and deemed adequate to withstand the effects of high-dose therapy planned for this protocol. Have given voluntary informed consent. Exclusion Criteria: Patients are ineligible for this protocol if they: Have a co-morbid medical condition, a psychiatric condition, or organ dysfunction that makes them at high-risk for treatment failure, for failed medical compliance, or for regimen-related toxicity from high-dose therapy. Patients with any of the following will be excluded: Pulmonary: hemoglobin (Hb)-adjusted diffusing capacity of lung for carbon monoxide (DLCO) < 60%, forced expiratory volume in 1 second (FEV1) < 70% of predicted, or receive continuous supplemental oxygen; Cardiac: left ventricular ejection fraction (LVEF) < 50% or on any treatment for congestive heart failure; Renal: serum creatinine greater than 2.0 or calculated creatinine clearance < 50 cc/min; Liver: ALT, AST, or serum bilirubin > 1.5 x upper limit of normal (ULN). Any patient with elevated transaminases should have careful evaluation for the cause and liver biopsy may be required by the principle investigator. An elevated alkaline phosphatase should be fractionated and, if of liver origin, should be evaluated as for transaminases. Are female and are pregnant, lactating, or have a positive pregnancy test. Have a history of previous malignancy except for non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for > 5 years Are HIV positive Refractory malignancy: acute leukemia with greater than 30% blasts in bone marrow unless with untreated first relapse of AML or untreated myelodysplastic syndrome evolved to AML. Acute leukemia with greater than 1000 blasts/ul in peripheral blood. Uncontrolled central nervous system (CNS) leukemia or lymphoma. Prior autologous or allogeneic transplantation using a myeloablative regimen. Uncontrolled hypertension (systolic blood pressure [SBP] > 140, diastolic blood pressure [DBP] > 90) or hypertension requiring > 2 drugs for good control (SBP < 130, DBP < 90). Invasive mold infection that is uncontrolled or has received less than one month of antifungal therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Stephens, RN, BSN, OCN
Phone
303-336-2183
Email
Nicole.Stephens@USOncology.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juli Murphy, CCRC
Phone
303-285-5087
Email
Juli.Murphy@USOncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter McSweeney, MD
Organizational Affiliation
Colorado Blood Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Blood and Marrow Transplant Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Bearman, MD
First Name & Middle Initial & Last Name & Degree
Robert Rifkin, MD
First Name & Middle Initial & Last Name & Degree
Mark Brunvand, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Matous, MD
First Name & Middle Initial & Last Name & Degree
Michael Maris, MD

12. IPD Sharing Statement

Learn more about this trial

Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation

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