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AMD3100 With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed HSC Collection/Attempts

This study is currently recruiting participants.
Verified by Genzyme, July 2008

Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00396331
  Purpose

Patients who would benefit from an autologous stem cell transplant, who have failed previous collections or collection attempts with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines, chemotherapy and cytokines and bone marrow harvests and who meet the inclusion/exclusion criteria are eligible to enter this study. Once 70 patients have enrolled, subsequent patients enrolled must have a diagnosis of lymphoma.

The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 on the evening prior to each day of apheresis.

Patients will undergo mobilization with G-CSF. On the 4th Day, AMD3100 will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter. Patients will continue to receive G-CSF on each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses or until ≥2 x 10e6 CD34+ cells/kg are collected, whichever occurs first.

If enough cells are collected the patient will be treated with high-dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF with AMD3100 mobilization regimen.


Condition Intervention Phase
Autologous Stem Cell Transplantation
Drug: AMD3100
Procedure: Stem Cell Mobilization
Phase II

MedlinePlus related topics:   Lymphoma   

Drug Information available for:   Granulocyte colony-stimulating factor    JM 3100   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Poor Mobilizing Adult Patients Who Have Previously Failed Stem Cell Collection/Attempts

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • To determine if AMD3100, given with a G-CSF mobilizing regimen, is generally safe and well tolerated. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To determine the percentage of patients who previously failed mobilization with conventional methods who are successfully mobilized by AMD3100 given with G-CSF. [ Time Frame: Maximum of 7 days from first dose to last ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the times of PLT and PMN engraftment. [ Time Frame: from transplant to engraftment ] [ Designated as safety issue: No ]
  • To evaluate the durability of engraftment after transplantation [ Time Frame: 3, 6 and 12 months post-transplant. ] [ Designated as safety issue: No ]
  • To examine the pharmacokinetics of repeated doses of AMD3100 [ Time Frame: after each dose of AMD3100 ] [ Designated as safety issue: No ]
  • To determine if non-Hodgkin's lymphoma tumor cells are mobilized after either G-CSF mobilization or AMD3100 administration. [ Time Frame: after G-CSF mobiliation period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   100
Study Start Date:   July 2005
Estimated Study Completion Date:   August 2009

Detailed Description:

This is a Phase 2, multicenter, prospective, observational, open-label study. Once 70 patients have enrolled, subsequent patients enrolled must have a diagnosis of lymphoma. Patients who would benefit from an autologous stem cell transplant, who have failed previous collections or collection attempts with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines, chemotherapy and cytokines and bone marrow harvests and who meet the inclusion/exclusion criteria are eligible to receive AMD3100 as outlined in this protocol. The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 on the evening prior to each day of apheresis.

Patients will undergo mobilization with G-CSF (10 µg/kg) for 4 days. On Day 4, AMD3100 (240 µg/kg) will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis. Patients will continue to receive G-CSF on each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses or until ≥2 x 10e6 CD34+ cells/kg are collected, whichever occurs first. In addition, the mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of AMD3100 will be examined.

After the last apheresis has been completed, or after the patient has collected ≥2 x 10e6 CD34+ cells/kg, he/she will be treated with high-dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF with AMD3100 mobilization regimen. In the event that the minimum number of ≥2 x 10e6 cells for transplantation are not obtained from the first mobilization with AMD3100, cells may be retained and pooled for transplantation with those from a second mobilization with AMD3100, at the investigator's discretion. If a second mobilization with AMD3100 is attempted, a minimum rest interval of one week should be allowed between the last apheresis of the first regimen and the first dose of G-CSF of the second. The number of CD34+ cells mobilized in the peripheral blood (PB),collected in the apheresis product, and the number of apheresis sessions performed will be measured. Success of the transplantation will be evaluated.

  Eligibility
Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age 18 to 78 years
  • Eligible to undergo autologous transplantation
  • Has failed previous collections or collection attempts with a mobilization regimen of G-CSF, chemotherapy and G-CSF or any other conventional therapy including cytokines, chemotherapy and cytokines or bone marrow harvest.
  • ECOG performance status of 0 or 1
  • ≥3 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for the purpose of this study) NOTE: Although thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for the purpose of this study, none are to be administered within 7 days prior to the first dose of G-CSF (see Exclusion Criteria).
  • The patient has recovered from all acute toxic effects of prior chemotherapy
  • WBC >2.5 x 10e9/l
  • Absolute neutrophil count >1.5 x 10e9/l
  • Platelet count >85 x 10e9/l
  • Serum creatinine ≤1.5 mg/dl
  • Creatinine clearance >60 ml/min
  • SGOT, SGPT and total bilirubin <2x upper limit of normal
  • Left ventricle ejection fraction >45% (by normal ECHO or MUGA scan)
  • FEV1 >60% of predicted or DLCO ≥45% of predicted
  • No active infection of hepatitis B or C
  • Negative for HIV
  • Signed informed consent
  • Women of child-bearing potential agree to use an approved form of contraception

Exclusion Criteria:

  • Once 70 patients have enrolled, patients with diagnoses other than lymphoma are not eligible (eg, AML CLL, or MM).
  • A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
  • A residual acute medical condition resulting from prior chemotherapy
  • Received thalidomide, dexamethasone, and/or Velcade™ within 7 days prior to the first dose of G-CSF
  • Brain metastases or carcinomatous meningitis
  • Acute infection
  • Fever (temperature >38°C/100.4°F)
  • Hypercalcaemia (>1 mg/dl above the ULN)
  • Positive pregnancy test in female patients
  • Lactating females
  • Patients of child-bearing potential unwilling to implement adequate birth control
  • Patients whose actual body weight exceeds 175% of their ideal body weight
  • Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the Mobilization phase
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396331

Contacts
Contact: Medical Information     800-745-4447     MedInfo@genzyme.com    
Contact: Medical Information     617-252-7832     MedInfo@genzyme.com    

Locations
United States, California
City of Hope National Medical Center`     Recruiting
      Duarte, California, United States, 91010
      Contact: Nigel Cheng     626-359-8111 ext 62968        
      Principal Investigator: Auayporn Nademanee, MD            
United States, Florida
H. Lee Moffitt Cancer Center     Recruiting
      Tampa, Florida, United States, 33612-9497
      Contact: Dawn Garrett     813-745-7227     garretdl@moffitt.usf.edu    
      Principal Investigator: Lia E Perez, MD            
United States, Georgia
Blood & Marrow Transplant Group of Georgia     Recruiting
      Atlanta, Georgia, United States, 30342
      Contact: Melanie Hawkins     404-255-1930 ext 1190     Melanie.Hawkins@Northside.com    
      Principal Investigator: Scott Solomon, MD            
United States, Michigan
University of Michigan Comprehensive Cancer Center     Recruiting
      Ann Arbor, Michigan, United States, 48109-0473
      Contact: Nancy McCullough     734-936-8538        
      Principal Investigator: Shin Mineishi, MD            
United States, Mississippi
University of Mississippi Medical Center, Div of Hematology     Recruiting
      Jackson, Mississippi, United States, 39216
      Contact: Dana Delasky     601-984-5615        
      Principal Investigator: Stephanie Elkins, MD            
United States, Missouri
Kansas City Cancer Centers     Recruiting
      Kansas City, Missouri, United States, 64111
      Contact: Shaun DeJarnette     816-960-6069     shaun.dejarnette@usoncology.com    
      Principal Investigator: Joseph McGuirk, MD            
United States, New Jersey
Hackensack University Medical Center     Recruiting
      Hackensack, New Jersey, United States, 07601
      Contact: Angelica Panganiban     201-996-5843        
      Principal Investigator: Scott Rowley, MD            
United States, Virginia
Virginia Commonwealth University - Massey Cancer Center     Recruiting
      Richmond, Virginia, United States, 23298-0037
      Contact: Cathy Roberts     804-828-1292        
United States, Wisconsin
University of Wisconsin, Blood and Bone Marrow Transplant     Recruiting
      Madison, Wisconsin, United States, 53792-5156
      Contact: Teri Mitchell     608-263-8629        
      Principal Investigator: Peiman Hematti, MD            

Sponsors and Collaborators
Genzyme

Investigators
Principal Investigator:     John McCarty, MD     Virginia Commonwealth University    
  More Information


Responsible Party:   Genzyme ( Medical Monitor )
Study ID Numbers:   AMD31002112
First Received:   November 2, 2006
Last Updated:   August 1, 2008
ClinicalTrials.gov Identifier:   NCT00396331
Health Authority:   United States: Food and Drug Administration

Keywords provided by Genzyme:
Multiple Myeloma  
Non-Hodgkin's Lymphoma  
autologous transplantation  
AMD3100  
stem cell mobilization  

Study placed in the following topic categories:
Multiple myeloma
JM 3100
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008




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