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Trial record 32 of 1446 for:    Hematologic neoplasm

Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT00914849
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : August 24, 2016
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 1, 2009
First Posted Date  ICMJE June 5, 2009
Results First Submitted Date  ICMJE July 14, 2016
Results First Posted Date  ICMJE August 24, 2016
Last Update Posted Date May 17, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant [ Time Frame: Completion of enrollment of all donors (17 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum CD34/kg (2 X 106) necessary for allogeneic stem cell transplant when compared to our historic group who received 240ug SC AMD3100. [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00914849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Number of Donors Who Experience Grade 3-4 Infusional Toxicity [ Time Frame: Up to Day 2 ]
  • Number of Recipients Who Have Neutrophil Engraftment [ Time Frame: Day 21 ]
  • Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1 and Day 2 ]
    -Blood samples for pharmacokinetics were drawn on the following schedule:
    • prior to IV infusion
    • 15 minutes after start of infusion
    • 30 minutes after start of infusion
    • 1 hour after start of infusion
    • 4 hours after start of infusion
    • 6 hours after start of infusion
    • 9 hours after start of infusion
    • 24 hours after start of infusion
  • Pharmacokinetics of IV AMD3100 as Measured by Half Life [ Time Frame: Day 1 and Day 2 ]
    -Blood samples for pharmacokinetics were drawn on the following schedule:
    • prior to IV infusion
    • 15 minutes after start of infusion
    • 30 minutes after start of infusion
    • 1 hour after start of infusion
    • 4 hours after start of infusion
    • 6 hours after start of infusion
    • 9 hours after start of infusion
    • 24 hours after start of infusion
  • Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC) [ Time Frame: Day 1 and Day 2 ]
  • Rate of Acute GVHD (Grade II-IV) in Recipients [ Time Frame: Day 0-Day 100 (acute) ]
  • Rate of Acute GVHD (Grade III-IV) in Recipients [ Time Frame: Day 0-Day 100 (acute) ]
  • Time to Neutrophil Engraftment for Recipients [ Time Frame: Up through Day 100 ]
    Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.
  • Time to Platelet Engraftment for Recipients [ Time Frame: Up to Day 100 ]
    Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.
  • Transplant Related Mortality Rate for Recipients [ Time Frame: Day 100 ]
    Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.
  • Grade 3-4 Toxicity for Recipients [ Time Frame: 1 year ]
    Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.
  • Rate of Chronic GVHD in Recipients [ Time Frame: Day 101-1 year ]
  • Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure [ Time Frame: Up to Day 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
  • To estimate with 95% confidence intervals the proportion of donors who experience grade 3-4 infusional toxicity & the proportion from whom ≥ 2.0 x 10e6 CD34+ cells/kg recipient weight are safely mobilized following 1 or 2 intravenous infusions. [ Time Frame: 30 days ]
  • To determine the kinetics of mobilization using IV AMD3100 and to determine if stem cell products collected after mobilization with IV AMD3100 can be used safely for transplant in HLA-matched recipients as measured by neutrophil engraftment by day +21. [ Time Frame: 21 days ]
  • To determine the pharmacokinetics and pharmacodynamics of IV AMD3100 on stem cell and T-cell phenotyping and on immune reconstitution after transplantation. [ Time Frame: 1 day ]
  • To determine the rate of acute GVHD and chronic GVHD in patients who receive IV AMD3100 mobilized peripheral blood stem cells. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies
Official Title  ICMJE A Phase II Study Evaluating the Safety and Efficacy of Intravenous AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies
Brief Summary To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.
Detailed Description
  • To reduce the number of donors treated with intravenous (IV) AMD3100 who require a second collection to obtain the minimum CD34/kg (2 X 106) necessary for allogeneic stem cell transplantation when compared to our historic group who received 240ug SC AMD3100 from 33% (8 in 24) to 11% (3 in 27).
  • To estimate with 95% confidence intervals the proportion of human leukocyte antigen (HLA)-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom ≥ 2.0 x 10e6 CD34+ cells/kg recipient weight are safely mobilized following one or two intravenous infusions.
  • To determine the kinetics of stem cell and lymphocyte mobilization using IV AMD3100 and to determine if peripheral blood stem cell products collected after mobilization with IV AMD3100 can be used safely for hematopoietic cell transplantation in HLA-matched recipients as measured by neutrophil engraftment by day +21.
  • To determine the pharmacokinetics and pharmacodynamics of IV AMD3100 on stem cell and T-cell phenotyping and on immune reconstitution after transplantation.
  • To determine the rate of acute graft-versus-host disease (GVHD) and chronic GVHD in patients who receive IV AMD3100 mobilized peripheral blood stem cells.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hematologic Neoplasms
Intervention  ICMJE
  • Drug: AMD3100
    Other Names:
    • Mozobil
    • Plerixafor
  • Procedure: Leukopheresis
  • Procedure: Stem cell transplant
Study Arms  ICMJE
  • Experimental: Arm 1 - Donor
    • Day 1

      • AMD3100 320 ug/kg IV
      • Leukopheresis
    • Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)

      • AMD3100 320 ug/kg IV
      • Leukopheresis
    Interventions:
    • Drug: AMD3100
    • Procedure: Leukopheresis
  • Experimental: Arm 2 - Recipient

    Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM

    Day 0 = Stem Cell Transplant

    Intervention: Procedure: Stem cell transplant
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: January 18, 2013)
68
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2009)
27
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Donor Eligibility

  • Donor is 18 to 70 years of age inclusive.
  • If female and of child-bearing age: must be non-pregnant, not breast feeding and agree to use adequate contraception.
  • Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
  • Donor must be willing to provide written informed consent.
  • Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
  • Adequate renal function as defined by a calculated serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation).
  • Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
  • Adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication.
  • Donor must be HIV-1&2 antibody and HTLV-I&II antibody sero-negative, by Food and Drug Administration (FDA) licensed test.
  • Donor must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Donor must demonstrate ability to be compliant with study regimen.
  • Donor must not have an active infection at the time of study entry.
  • Donor does not have active alcohol or substance abuse within 6 months of study entry.
  • Donor is not currently enrolled on another investigational agent study.
  • Donor does not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation.

Recipient Eligibility

  • Recipient must have available the successful collection of an AMD3100 mobilized product. When an adequate collection cannot be obtained using G-CSF, some recipients may need to receive a combined product of mobilized cells with AMD3100 and g granulocyte-colony stimulating factor (G-CSF). Recipients who receive less than 2.0 X 106 CD34+ cells/kg/actual recipient weight after two days of IV AMD3100 will not be considered "eligible" but followed per protocol for safety purposes only.
  • Patient is 18 to 65 years of age inclusive.
  • Patient is willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
  • Patient must provide signed informed consent.
  • If female and of child-bearing age: must be non-pregnant, not breast feeding, and uses adequate contraception.
  • Patient must have one of the following diagnoses:

    • Acute myelogenous leukemia (AML) in 1st or subsequent remission or in relapse,
    • Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission or in relapse,
    • Myelodysplastic syndrome either intermediate 1 or 2, or high risk by the International Prognostic Scoring System,
    • Chronic myelogenous leukemia (CML) in accelerated or second chronic phase,
    • Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission, or refractory relapse,
    • Chronic lymphocytic leukemia (CLL), Rai Stage 2-4, failing at least 2 prior regimens, OR
    • Multiple myeloma (MM), Stage 2-3.
  • Adequate cardiac function with a left ventricular ejection fraction ≥ 40%.
  • Adequate pulmonary function defined as NO severe or symptomatic restrictive or obstructive lung disease, and formal pulmonary function testing showing an FEV1 ≥50% of predicted and a DLCO ≥40% of predicted, corrected for hemoglobin.
  • Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation).
  • Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
  • Adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous central nervous system (CNS) tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain.
  • No evidence of active infection at the time of the transplant preparative regimen or at time of transplantation.
  • Patient must be HIV-1&2 antibody and HTLV-I & II antibody sero-negative, by FDA licensed test.
  • Patient has an ECOG performance status of 0 or 1.
  • Patient must demonstrate ability to be compliant with medical regimen.
  • Patient must not have active alcohol or substance abuse within 6 months of study entry.
  • Patient must not be enrolled on another investigational agent concurrently.
  • Patient must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient.

Exclusion Criteria:

  • See Inclusion criteria above
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT00914849
Other Study ID Numbers  ICMJE 09-0713 / 201103429
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John DiPersio, M.D., Ph.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date April 2017

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