Status:
COMPLETED
AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Autologous Stem Cell Transplantation
Eligibility:
All Genders
18-78 years
Phase:
PHASE2
Brief Summary
This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBS...
Detailed Description
This is a Phase 2, multicenter, prospective, open-label study. Once 70 patients have enrolled, subsequent patients enrolled should have a diagnosis of lymphoma. Patients who would benefit from an auto...
Eligibility Criteria
Inclusion
- Eligible to undergo autologous transplantation
- Has failed previous collections or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor (G-CSF), chemotherapy and G-CSF or any other conventional therapy including cytokines, chemotherapy and cytokines or bone marrow harvest.
- Eastern Co-operative Oncology Group (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
- White blood cell count (WBC) \>2.5\*10\^9/L
- Absolute neutrophil count \>1.5\*10\^9/L
- Platelet count \>85\*10\^9/L
- Serum creatinine ≤1.5 mg/dl
- Creatinine clearance \>60 ml/min
- Aspartate aminotransferase (AST), alanine transaminase (ALT) and total bilirubin \<2x upper limit of normal (ULN)
- Left ventricle ejection fraction \>45% (by normal echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan)
- Forced expiratory volume in one minute (FEV1) \>60% of predicted or diffusion lung capacity for carbon monoxide (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
- Once 70 patients have enrolled, patients with diagnoses other than lymphoma are not eligible (eg, acute myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma).
- 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 Neupogen™, 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00396331
Start Date
October 1 2005
End Date
December 1 2009
Last Update
March 13 2014
Active Locations (8)
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1
City of Hope National Medical Center'
Duarte, California, United States, 91010
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497
3
Blood & Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
4
University of Mississippi Medical Center, Div of Hematology
Jackson, Mississippi, United States, 39216