Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | March 2010 |
| End Date: | November 2013 |
| Contact: | Edmund Waller, MD, PhD |
| Email: | ewaller@emory.edu |
| Phone: | 1-888-946-7447 |
Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
The purpose of this study is to test whether the addition of the drug plerixafor to
treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to
improve the chances of transplant. The study will look for the activation of a certain type
of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and
G-CSF. The investigators will follow the number of patients that achieve the target numbers
of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the
total number of CD34+ cells, will be compared to the numbers in previous studies testing
just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with
chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to
improve the chances of transplant. The study will look for the activation of a certain type
of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and
G-CSF. The investigators will follow the number of patients that achieve the target numbers
of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the
total number of CD34+ cells, will be compared to the numbers in previous studies testing
just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with
chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
Study is ongoing; no interim analysis.
Inclusion Criteria:
1. Age 18-70 years
2. MM or NHL patients in first or second complete or partial remission
3. ECOG performance status of 0 or 1
4. Up to 3 prior treatment regimens
5. Meet all eligibility requirements for autologous transplant.
6. Adequate marrow function defined as WBC >3,000; ANC >1,500/mm3 ; Platelets
>75,000/mm3
7. Adequate renal function defined as creatinine clearance > 30 mL/min by
Cockcroft-Gault
8. Adequate liver function defined as AST/ALT/Bilirubin < 2 times upper limit of normal
9. Able to provide informed consent
10. Women not pregnant and agree to use contraception
Exclusion Criteria:
1. High risk co-morbidities for acute treatment complications (e.g., symptomatic
coronary artery disease)
2. Brain metastases or carcinomatous meningitis
3. Previous treatment with high dose chemotherapy and autologous transplant.
4. Previous attempt to collect B-HPCs following mobilization with growth factors alone,
growth factors and chemotherapy, or plerixafor and growth factors.
5. Acute infection or unexplained fever >38°C
6. Weight > 175% of ideal body weight as defined by the Devine equation.
7. Experimental therapy within 4 weeks
8. Cytokine administration in the previous 14 days
We found this trial at
1
site
1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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