- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901225
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Plerixafor Rescue Mobilization For Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population.
The study hypothesis for this study is that patients with a circulating CD34+ count < 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation are eligible to enter into the study. The only change to the standard of care is the addition of 240 ug/kg Plerixafor following 5 days of (G-CSF) mobilization.
The results of the study will provide both numeric and categorical estimates of measurements of the safety and efficacy of Plerixafor. The primary efficacy endpoint, Treatment Success, is a binary response variable categorizing whether the patient was able to mobilize at least 2 X 10(6) CD34+ cells/kg within 3 days of apheresis.
The percentage of patients achieving Treatment Success will be summarized. All AEs will be followed for 30 days after the last apheresis or until the first dose of ablative chemotherapy, whichever occurs first. All SAEs will be followed for 6 months post-transplant or until relapse. All patients who receive at least one dose of Plerixafor will be included in all summaries of AEs.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 to 75 years.
- Diagnosis of NHL, HD or MM
- Eligible for autologous transplantation
- CD34+ cell count < 7 cells/ul after 5 days of mobilization with G-CSF or CD34+ cell count between 7 and 19 (inclusive) on day 5 of mobilization with G-CSF and < 1.3 x 106 CD34+ cells collected by apheresis on day 5 of G-CSF therapy.
- < or equal to 5 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- ≥ 3 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization (Rituxan and Lenalidomide are not considered chemotherapy for the purpose of this study)
- Total dose of melphalan < or equal to 200 mg
- ECOG performance status of 0 or 1
- Recovered from all acute toxic effects of prior chemotherapy
- Absolute PMN count > 1.0 X 10(9)/l prior to first dose of G-CSF
- PLT count > 75 X 10(9)/l prior to first dose of G-CSF
- Serum creatinine < or equal to 2.5 mg/dl
- SGOT, SGPT and total bilirubin < 2 X upper limit of normal (ULN) prior to the first dose of G-CSF
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as determined by standard institutional practice
- Signed informed consent
- Patients of childbearing potential agree to use an approved form of contraception
Exclusion Criteria:
- A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
- Failed previous stem cell collection or collection attempts
- A residual acute medical condition resulting from prior chemotherapy
- Active brain metastases or carcinomatous meningitis
- Active infection requiring antibiotic treatment (excluding controlled catheter-related bacteremia)
- Received prior radio-immunotherapy with Zevalin or Bexxar
- Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
- Positive pregnancy test in female patients
- Lactating females
- Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G-CSF plus Plerixafor
Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
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On Day 5 of G-CSF mobilization,
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.
Time Frame: 5 days after receiving G-CSF
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5 days after receiving G-CSF
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing a Grade III/IV Toxicity
Time Frame: 6 months post transplant or until relapse
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Safety of plerixafor as measured by Grade III/IV Toxicity
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6 months post transplant or until relapse
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Number of Subjects Experiencing Graft Failure
Time Frame: 12 months
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To investigate the hematological activity of Plerixafor as measured by Graft Failure.
Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).
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12 months
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Days to Absolute Neutrophil Count >500
Time Frame: 12 months
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12 months
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Number of Subjects Experiencing Durability of Engraftment
Time Frame: 12 months
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Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation.
Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.
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12 months
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Platelet Engraftment
Time Frame: 12 months
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Days to platelet count >20,000
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Multiple Myeloma
- Hodgkin Disease
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Plerixafor
Other Study ID Numbers
- Pro00014563
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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