- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00720603
This is a Multi-center, Single Arm, Open Label Study Intended to Provide Expanded Access to Plerixafor for Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) Who Are to Receive Treatment With an Autologous Peripheral Stem Cell Transplant. (EAP)
March 19, 2015 updated by: Genzyme, a Sanofi Company
Expanded Acess Study of Plerixafor and G-CSF for the Mobilization and Collection of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease or Multiple Myeloma
The purpose of this program is to provide expanded access to plerixafor for patients with NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell transplant.
Study Overview
Status
No longer available
Intervention / Treatment
Detailed Description
The Expanded Access Program (EAP)(protocol number MOZ00607) is an open label study intended to provide access to plerixafor for patients with non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma who are to receive treatment with an autologous hematopoietic stem cell transplant.
Patients who have previously failed stem cell mobilization attempts or who have previously received an autologous or allogeneic stem cell transplant are not eligible to enroll in this program.
The standard of care regimen for stem cell mobilization includes a growth factor, G-CSF, to increase peripheral blood stem cells.
Plerixafor is given on the evening prior to doses of standard treatment with G-CSF.
The combination of G-CSF and plerixafor has the potential to increase the number of circulating stem cells.
The stem cells develop into specialized white blood cells and platelets that are necessary for immune system function and normal blood clotting.
The stem cells are removed by a process called apheresis, in which blood is drawn from the patient, the stem cells are separated from the plasma, and the plasma is returned to the patient.
The separated stem cells are frozen, similar to the blood banking process.
The patient then receives chemotherapy according to the institutional standard.
After chemotherapy, stem cell transplant is intended to replenish cells in the bone marrow that may be destroyed by chemotherapy.
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of MM, NHL, or HD.
- Eligible for a planned autologous peripheral stem cell transplantation.
- Written informed consent.
- At least 18 years of age (inclusive).
- Easter Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, I.e., eligible by institutional standards for autologous stem cell transplant.
- Male and female patients of childbearing potential agree to use appropriate form of contraception (i.e., condom, diaphragm cervical cap, etc.) while on study and for at least 3 months following the last treatment. Female patients of child-producing potential must have a negative serum pregnancy test confirmed within 7 days of beginning mobilization therapy.
- White blood cell (WBC) count greater than or equal to 2.5x10^9/L.
- Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L.
- Platelet count greater than or equal to 100x10^9/L.
- Serum creatinine less than or equal to 2.2 mg/ dL.
- AST/SGOT, ALT/SGPT, and total bilirubin less than 2.5 x upper limit of normal (ULN).
Exclusion Criteria:
- History of acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myelocytic leukemia (AML), chronic myelocytic leukemia (CML), myelodysplastic syndrome (MDS), plasma cell leukemia or other leukemia.
- Failed previous CD34+ cell collection attempts.
- Prior autologous or allogenic transplantation.
- less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy was with nitrosourea or mitomycin (for therapies with prolonged effects, a treatment-free interval of at least 2 half-lives should be considered) with the exception of the following: Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) is allowed up to 7 days prior to the first dose of G-CF.
- Bone marrow involvement greater than 20% assessed based on the most recent bone marrow aspirate or biopsy.
- Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization.
- HIV positive.
- Active hepatitis B (positive HBsAg) or hepatitis C.
- Acute infection (febrile, i.e., temperature greater than 38 degrees Celsius/100.4 degrees Fahrenheit) within 24 hours prior to dosing or antibiotic therapy within 1 week of enrollment.
- Hypercalcemia as evidenced by greater than 1 mg/dL above ULN.
- Previously received investigational therapy with 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
- Central nervous system involvement including brain metastases of leptomeningeal disease.
- Pregnant or nursing women.
- ECG or study result (exercize study, scan) indicative of previously undiagnosed cardiac ischemia or a history of clinically significant rhythm disturbance (arrhythmias), or other conduction abnormality in the last year that in the opinion of the Investigator warrants exclusion of the subject from the trial.
- Co-morbid conditions(s), which in the opinion of the Investigator, renders the patient at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 21, 2008
First Submitted That Met QC Criteria
July 22, 2008
First Posted (Estimate)
July 23, 2008
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 19, 2015
Last Verified
March 1, 2015
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
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Plerixafor
Other Study ID Numbers
- MOZ00607
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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