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Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies
This study is ongoing, but not recruiting participants.
First Received: October 17, 2005   Last Updated: April 15, 2009   History of Changes
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00241358
  Purpose

The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.


Condition Intervention Phase
Leukemia, Myeloid, Acute
Leukemia, Myelogenous, Chronic
Leukemia, Lymphoblastic, Acute
Lymphocytic Leukemia, Chronic
Myelodysplastic Syndromes
Multiple Myeloma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Drug: AMD3100
Phase I
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma
Drug Information available for: Plerixafor JM 3100
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study Evaluating the Safety and Efficacy of AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • neutrophil engraftment [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • platelet engraftment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • acute graft-versus-host disease (GVHD) [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • chronic GVHD [ Time Frame: > 100 days post transplant ] [ Designated as safety issue: No ]
  • treatment related mortality [ Time Frame: survival ] [ Designated as safety issue: No ]
  • determination of infusional toxicity [ Time Frame: 35 hours post infusion ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • determination of relapse [ Time Frame: time of relapse ] [ Designated as safety issue: No ]
  • determination of survival [ Time Frame: survival ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: May 2003
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: AMD3100

The donor will receive AMD3100 by two different methods of administration. The first dose will be given by intravenous infusion on day -3. The following doses will be tested:

  • Cohort 1: 80 ug/kg IV
  • Cohort 2: 160 ug/kg IV
  • Cohort 3: 240 ug/kg IV
  • Cohort 4: 320 ug/kg IV
  • Cohort 5: 400 ug/kg IV
  • Cohort 6: 480 ug/kg IV

On day 1, AMD3100 240 ug/kg SQ will be administered. If the donor does not reach the target collection a second SQ dose will be administered on day 3.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Donor criteria:

  • Donor is 18 to 70 years of age inclusive
  • If female and of child-bearing age, must be:

    • non-pregnant,
    • not breast feeding and
    • using adequate contraception
  • Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell 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 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, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test.
  • Donor must have an 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 in 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

Patient criteria:

  • 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
    • using adequate contraception

Patient must have one of the following diagnoses:

  • AML in 1st or subsequent remission or in relapse
  • ALL in 1st or subsequent remission or in relapse
  • MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring System
  • CML in accelerated or second chronic phase
  • NHL or HD in 2nd or greater complete remission, partial remission,or refractory relapse
  • CLL Rai Stage 2-4, failing at least 2 prior regimens
  • 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 forced expiratory volume at 1 second (FEV1) ≥50% of predicted and a diffusion capacity of the lung for carbon monoxide (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 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 the time of transplantation
  • Patient must be HIV-1 & 2 antibody, HIV-1 antigen, 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 concurrently enrolled on another study involving an investigational agent
  • Patient must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241358

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: John F. DiPersio, M.D., Ph.D. Washington University School of Medicine
  More Information

Publications:
Responsible Party: Washington University ( John DiPersio, M.D., Ph.D. )
Study ID Numbers: 03-0349
Study First Received: October 17, 2005
Last Updated: April 15, 2009
ClinicalTrials.gov Identifier: NCT00241358     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Plerixafor
Stem cell transplantation
Stem cells
Mobilization

Study placed in the following topic categories:
Leukemia, Lymphoid
Precancerous Conditions
Hematologic Neoplasms
JM 3100
Blood Protein Disorders
Paraproteinemias
Leukemia, Myeloid, Acute
Hemostatic Disorders
Leukemia
Preleukemia
Hemorrhagic Disorders
Anti-Retroviral Agents
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Lymphoma
Acute Lymphoblastic Leukemia
Anti-HIV Agents
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hematologic Diseases
Blood Coagulation Disorders
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Hodgkin's Disease
Leukemia, Myeloid
Antiviral Agents
Multiple Myeloma
Lymphatic Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Leukemia, Lymphoid
Precancerous Conditions
Hematologic Neoplasms
JM 3100
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Neoplasms by Site
Pathologic Processes
Hemorrhagic Disorders
Anti-Retroviral Agents
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Syndrome
Cardiovascular Diseases
Lymphoma
Hodgkin Disease
Anti-HIV Agents
Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Vascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009