Access Program for Use of AMD3100 to Increase Peripheral Blood Stem Cells for Transplantation in Patients Who Have Failed Standard Therapy Stem Cell Mobilization (CUP)

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Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00291811
First received: February 13, 2006
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The purpose of this program is to provide access to AMD3100 for patients who would benefit from an autologous stem cell transplant but who have either previously failed to collect enough cells for transplant following standard therapy or are not considered by their physician to have a reasonable chance of collecting enough cells for transplant.


Condition Intervention
Autologous Stem Cell Transplant
Drug: AMD3100 + G-CSF

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use Protocol for the Use of AMD3100 to Mobilize Peripheral Blood Stem Cells for Collection and Transplantation

Resource links provided by NLM:


Further study details as provided by Sanofi:

Study Start Date: October 2003
Intervention Details:
    Drug: AMD3100 + G-CSF
    Subcutaneous injection of 240 mcg/kg on the evening prior to each apheresis session
    Other Name: Plerixafor(injection)
Detailed Description:

The purpose of this program is to provide access to AMD3100 for patients who would benefit from an autologous stem cell transplant but who have either previously failed to collect enough cells for transplant following standard therapy or are not considered by their physician to have a reasonable chance of collecting enough cells for transplant.

Compassionate use is a way to provide experimental treatment to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available.

Peripheral blood stem cells are obtained by apheresis following a stem cell mobilization regimen. The standard of care regimen for stem cell mobilization includes a growth factor, G-CSF. AMD3100 is given in addition to G-CSF prior to each apheresis session. If enough peripheral blood stem cells for transplant are collected, the patient is treated with high dose chemotherapy in preparation for transplant and is transplanted with cells obtained from the AMD3100 and G-CSF regimen. Patients are followed for safety and transplant outcomes for up to 12 months after transplant.

  Eligibility

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

Inclusion Criteria:

  • Patient is eligible for autologous transplant
  • Patient has failed previous conventional therapies for stem cell collection, or is not considered by the physician to have a reasonable chance of collecting enough cells for transplant
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patient has recovered from all acute toxic effects of prior chemotherapy
  • Patient has white blood cell count greater than 2.5 x 10^9 cells/L
  • Patient has absolute neutrophil count (ANC) greater than 1.5 x 10^9 cells/L
  • Patient has platelet count greater than 85 x 10^9 cells/L
  • Patient has serum creatinine less than or equal to 1.5 mg/dL
  • Patient has creatinine clearance greater than 60 mL/min
  • Patient has liver function tests less than 2x upper limit of normal
  • Patient has left ventricle ejection fraction greater than 45%
  • Patient has forced expiratory volume in 1 second (FEV1) greater than 60% of predicted or diffusing capacity of lung carbon monoxide (DLCO) and greater than or equal to 45% of predicted
  • Patient has no active infection of hepatitis B or C
  • Patient is negative for HIV
  • Patient has signed informed consent
  • Women of child bearing potential agree to use an approved form of contraception

Exclusion Criteria:

  • Patients with leukemia (Note: Patients with multiple myeloma must be evaluated for plasma cells or blasts within 24 hours prior to the first dose of AMD3100)
  • Patient has an existing condition which, in the view of the Investigator, renders the patient at high risk from treatment complications
  • Patient has a residual acute medical condition resulting from prior chemotherapy
  • Patient has brain metastases or carcinomatous meningitis
  • Patient has an acute infection
  • Patient has a fever (temperature greater than 38 degrees C/100.4 degrees F)
  • Patient has hypercalcaemia greater than 1 mg/dL above the upper limit of normal
  • Female patient has positive pregnancy test
  • Female patient is lactating
  • Patient is of child-bearing potential and is unwilling to use adequate birth control
  • Patients with actual body weight exceeding 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
  • Patients who experience a deterioration in health between the time of enrollment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal Investigator, or Sponsor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291811

Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00291811     History of Changes
Other Study ID Numbers: AMD3100-CUP001
Study First Received: February 13, 2006
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Sanofi:
AMD3100
G-CSF

Additional relevant MeSH terms:
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014