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

NCT00291811 | Unknown

• 1 other identifier: AMD3100-CUP001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autologous Stem Cell Transplant

Keywords

AMD3100; G-CSF

Interventions

AMD3100 + G-CSF DRUG

Subcutaneous injection of 240 mcg/kg on the evening prior to each apheresis session

Also known as: Plerixafor(injection)

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Related Publications (1)

• Deol A, Abrams J, Masood A, Al-Kadhimi Z, Abidi MH, Ayash L, Lum LG, Ratanatharathorn V, Uberti JP. Long-term follow up of patients proceeding to transplant using plerixafor mobilized stem cells and incidence of secondary myelodysplastic syndrome/AML. Bone Marrow Transplant. 2013 Aug;48(8):1112-6. doi: 10.1038/bmt.2013.10. Epub 2013 Mar 11.

  PMID: 23474805 DERIVED

MeSH Terms

Interventions

plerixafor; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 15, 2006
• Study Start: October 1, 2003
• Last Updated: February 11, 2014

Record last verified: 2014-02