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Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00304018
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : August 14, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE March 15, 2006
First Posted Date  ICMJE March 17, 2006
Last Update Posted Date August 14, 2013
Study Start Date  ICMJE October 2002
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies [ Time Frame: up to 24 months post-transplant ]
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of > 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00304018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
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 Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
Official Title  ICMJE Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies
Brief Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and tacrolimus and prednisone after transplant may stop this from happening.

PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.

Detailed Description

OBJECTIVES:

Primary

  • Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of > 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.

Secondary

  • Determine the toxicity of a myeloablative preparative regimen comprising busulfan, fludarabine, and etoposide prior to UCBT in these patients.
  • Determine the neutrophil and platelet recovery in patients treated with this regimen.
  • Determine the event-free and overall survival of patients treated with this regimen.
  • Evaluate lineage-specific chimerism after UCBT and assess the contribution of each individual cord blood unit to post-transplantation hematopoiesis in these patients.
  • Determine the incidence, severity, and timing of acute and chronic graft-vs-host disease in patients treated with this regimen.

OUTLINE: This is a pilot study.

  • Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours 4 times daily on days -7 and -4, etoposide IV over 4 hours on day -3, and anti-thymocyte globulin IV over 6 hours on days -2 and -1.
  • Donor umbilical cord blood transplantation (UCBT): Patients undergo donor UCBT on day 0. Beginning on day 7, patients receive sargramostim (GM-CSF) IV or subcutaneously once daily until blood counts recover.
  • Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously over 24 hours or orally twice daily beginning on day -2 and continuing until day 180 followed by a taper. Patients also receive oral prednisone twice daily on days 13-50 and then once daily on days 50-60, followed by a rapid taper.

After completion of study treatment, patients are followed periodically for approximately 2 years.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
Intervention  ICMJE
  • Biological: anti-thymocyte globulin
  • Biological: sargramostim
  • Drug: busulfan
  • Drug: etoposide
  • Drug: fludarabine phosphate
  • Drug: prednisone
  • Drug: tacrolimus
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: umbilical cord blood transplantation
Study Arms  ICMJE Experimental: cord blood transplant
Interventions:
  • Biological: anti-thymocyte globulin
  • Biological: sargramostim
  • Drug: busulfan
  • Drug: etoposide
  • Drug: fludarabine phosphate
  • Drug: prednisone
  • Drug: tacrolimus
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: umbilical cord blood transplantation
Publications * Not Provided

*   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: October 2, 2012)
5
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following advanced hematologic malignancies:

    • Acute myeloid leukemia (AML) meeting the following criteria:

      • Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:

        • High-risk cytogenetics (-7, -7q, -5, -5q, t[6,9], t[9,11], complex, Philadelphia chromosome positive [Ph+])
        • AML evolved from prior myelodysplasia
        • AML secondary to prior chemotherapy
        • Failed to achieve remission
        • In second or subsequent remission
      • Marrow blasts ≤ 10% (may be achieved using chemotherapy)
    • Myelodysplastic syndromes (MDS) with high-risk features

      • International Prognostic Scoring System (IPSS) score intermediate -2 or high-risk
      • Marrow blasts ≤ 20% (may be achieved using chemotherapy)
    • Acute lymphoblastic leukemia meeting the following criteria:

      • Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:

        • High-risk cytogenetics (Ph+, t[4,11], 11q23 abnormalities, and monosomy 7)
        • Required > 1 induction course to achieve remission
        • Failed to achieve remission
        • In second or subsequent remission
      • Marrow blasts ≤ 10% (may be achieved using chemotherapy)
    • Chronic myelogenous leukemia meeting ≥ 1 of the following criteria:

      • Accelerated phase
      • Chronic phase refractory to imatinib mesylate
      • Blastic phase

        • Marrow blasts ≤ 10% (may be achieved using chemotherapy)
    • Multiple myeloma meeting 1 of the following criteria:

      • Stage II or III disease with > first relapse or refractory disease
      • Newly diagnosed disease with chromosome 13 abnormalities
    • Lymphoma meeting the following criteria:

      • One of the following subtypes:

        • Diffuse large cell lymphoma
        • Mantle cell lymphoma
        • Peripheral T-cell lymphoma
        • T-natural killer (NK) cell lymphoma
        • Hodgkin's lymphoma
      • Disease failed to respond to primary therapy, progressed, or recurred after prior therapy

        • Patients who have failed autologous stem cell transplantation are eligible provided it has been > 1 year since transplant
  • No rapid progression of malignant disease
  • Not eligible for autologous stem cell transplantation
  • Available umbilical cord blood (1-3 units) donor matching at ≥ 4 of 6 HLA antigens (A, B, and DR)

    • Patients with an HLA-identical or 1 antigen-mismatched related donor OR a potential HLA-matched unrelated donor matching at > 6/8 (A, B, C, DR) alleles are not eligible

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Creatinine < 2.0 mg/dL
  • Creatinine clearance > 40 mL/min
  • Bilirubin < 2.0 mg/dL
  • AST and alkaline phosphatase < 3 times upper limit of normal
  • Hepatitis C and active hepatitis B allowed if patient has ≤ grade 2 inflammation or fibrosis by liver biopsy
  • Ejection fraction > 40% by echocardiogram or MUGA
  • DLCO > 40% of predicted
  • Not pregnant or nursing
  • Negative pregnancy test
  • No known HIV infection
  • No active infection requiring ongoing antibiotic treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT00304018
Other Study ID Numbers  ICMJE CDR0000463370
UCSF-02253
UCSF-H24045-21269-04
UCSF-2207
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Thomas G. Martin, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2013

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