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Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003335
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 15, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 15, 2012
Study Start Date  ICMJE January 1998
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2011)
rates of durable engraftment in patients [ Time Frame: day 42 ]
The primary study end point will be hematologic engraftment. Engraftment is defined as achieving ANC larger than or equal to 500 ul/mm3 of donor origin for three consecutive measurements on different days by day +42.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2011)
  • Event-free survival by clinical and pathological disease assessment [ Time Frame: at disease progression or death ]
  • incidence of recurrent disease in patients post UCB transplant [ Time Frame: post transplant ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
Official Title  ICMJE A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies
Brief Summary

RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.

PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.

Detailed Description

OBJECTIVES:

  • Determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation.
  • Determine the incidence of graft-versus-host-disease in this setting.
  • Describe the incidence of recurrent disease in these patients post UCB transplant.
  • Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients.
  • Determine specifically whether larger recipients can be durably engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment.

OUTLINE: Patients may undergo a back-up peripheral blood stem cell collection prior to treatment.

Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5 followed by melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV for three days on days -3 to -1. On day 0, patients receive umbilical cord blood infusion. If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5. Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months.

Patients are followed at least monthly for 1 year, then every 6 months for the second year, and then annually thereafter.

PROJECTED ACCRUAL: There will be a maximum of 48 patients accrued into this study over 4 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
Intervention  ICMJE
  • Biological: anti-thymocyte globulin
    antithymocyte globulin IV for three days on days -3 to -1
  • Drug: busulfan
    If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.
  • Drug: cyclosporine
    Cyclosporine begin on day -2 and continue for 6 months.
  • Drug: melphalan
    melphalan IV for three days on days -4 to -2
  • Drug: methylprednisolone
    Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.
  • Procedure: umbilical cord blood transplantation
    On day 0, patients receive umbilical cord blood infusion.
  • Radiation: radiation therapy
    9 fractions of total body irradiation (TBI) on days -9 to -5
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2011)
44
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed high risk malignancy including:

    • Acute nonlymphocytic leukemia (ANLL) after induction failure, or in first complete remission with high risk features including stem cell or biphenotypic classification (acute myeloid leukemia (AML) M0), erythroleukemia (AML M6), acute megakaryocytic leukemia (AML M7), cytogenic markers indicative of poor prognosis, or failure to achieve complete remission after standard induction therapy
    • Acute lymphocytic leukemia (ALL) or ANLL in second or subsequent remission
    • Chronic myeloid leukemia (CML) in chronic phase

      • CML with accelerated phase or blast crisis are eligible after reinduction chemotherapy converts disease to chronic phase
    • High risk ALL in first complete remission
    • Myelodysplastic syndrome with evidence of evolution to acute myeloid leukemia

      • Refractory anemia with excess blasts
      • Refractory anemia with excess blasts in transformation
    • Non-Hodgkin's lymphoma (NHL), ANLL, or ALL with recurrent disease after autologous stem cell transplantation
  • Must also meet all the following conditions:

    • No HLA-ABC/DR identical related bone marrow or UCB donor
    • No 5/6 antigen matched related bone marrow or UCB donor
    • Condition precludes waiting to search and find a donor in the National Marrow Donor Registry
  • Must have an available serologic matched umbilical cord blood unit in the New York Blood Center's Placental Blood Project
  • No active CNS disease

PATIENT CHARACTERISTICS:

Age:

  • Under 55 at time of umbilical cord blood transplantation

Performance status:

  • Zubrod 0-1
  • Karnofsky 80-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • For patients with ALL or ANLL in remission, CML in chronic phase, or NHL without marrow involvement who elect to undergo autologous peripheral blood stem cell collection and storage:

    • WBC at least 3,000/mm^3
    • Absolute neutrophil count at least 1,000/mm^3
    • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • ALT/AST no greater than 4 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction at least 80% of normal value for age)

Pulmonary:

  • FVC and FEV_1 at least 60% of predicted for age
  • For adults:

    • DLCO at least 60% of predicted

Other:

  • HIV negative
  • No active infections at time of autologous stem cell harvest or pretransplant cytoreduction
  • Not pregnant or nursing
  • Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior autologous stem cell transplantation allowed

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 54 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003335
Other Study ID Numbers  ICMJE CWRU4Y97
P30CA043703 ( U.S. NIH Grant/Contract )
NCI-G98-1429
CWRU4Y97 ( Other Identifier: Case Comprehensive Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Brenda W. Cooper, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP