Back to resultsCyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Primary Purpose
Hematologic Malignancies
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Malignancies focused on measuring Cyclophosphamide, Hematopoietic, Stem Cell, Mobilization, Hematologic Malignancy
Eligibility Criteria
Inclusion Criteria:
- All patients must have a pathologic diagnosis of one of the following malignancies:
Non-Hodgkin's Lymphoma, including B- and T-cell lymphoma Multiple Myeloma or another plasma cell dyscrasia (Waldenstrom, Amyloidosis)
- The patient must be approved for transplant by the treating Transplant physician.
- This must be the patient's FIRST mobilization attempt.
- Patients are eligible if an autologous transplant is planned within approximately 12 months from the time of collection of cells.
- Prior Treatment: No previous cytotoxic chemotherapy within 4 weeks prior to initiation of therapy. (This does not include immunomodulatory drugs (IMiDs), proteasome inhibitors, monoclonal antibodies or steroids.)
- No radiation within 4 weeks of mobilization attempt.
- Age >18, and < 75 years
- No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival.
- Informed consent must be signed prior to the treatment. Patients must willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. (Human protection committee approval of this protocol and a consent form is required.)
Exclusion Criteria:
- Medical, social, or psychological factors that would prevent the patient from receiving or cooperating with the full course of therapy.
- Documented hypersensitivity to any of the drugs used in the protocol.
Sites / Locations
- Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 2: Cyclophosphamide 3 gms/m(2)
Arm 1: 1.5 gms/m(2) Cyclophosphamide
Arm Description
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Outcomes
Primary Outcome Measures
Number of Nucleated Cells Collected Within the Apheresis Products
the investigator will identify the number of cells collected within the apheresis products
Number of CD34+ Cells Collected Within the Apheresis Products
the investigator will identify the number of CD34+ cells collected within the apheresis products
Secondary Outcome Measures
Resource Utilization - Transfusions of Red Blood Cells
Resources used during the mobilization and apheresis processes will be captured.
Resource Utilization- Transfusion of Platelets
Resources used during the mobilization and apheresis processes will be captured.
Resource Utilization- Hospitalizations
Resources used during the mobilization and apheresis processes will be captured.
Resource Utilization- Incidence of Febrile Neutropenia
Resources used during the mobilization and apheresis processes will be captured.
Toxicities During the Mobilization and Apheresis Processes
Toxicities during the mobilization and apheresis processes Grade 3 and higher
Full Information
NCT ID
NCT02139280
First Posted
March 3, 2014
Last Updated
January 28, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02139280
Brief Title
Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Official Title
A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
No prospective randomized trials have evaluated the most efficacious dose of cyclophosphamide to mobilize autologous stem cells. We previously demonstrated that the time to collection of autologous hematopoietic stem cells is 10-12 days following the one dose of cyclophosphamide and daily G-CSF (granulocyte-colony stimulating factor).9 This prospective randomized trial is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2) will be as efficacious as the intermediate dose (3 gm/m2), based on cell number collected, number of apheresis required and resource utilization.
Detailed Description
This prospective randomized trial is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2) will be as efficacious as the intermediate dose (3 gm/m2), based on cell number collected, number of apheresis required and resource utilization.
The time to collection of autologous hematopoietic stem cells was ten to twelve days following cyclophosphamide and daily filgrastim. Peripheral blood CD34+ cell numbers were examined beginning ten days after cyclophosphamide administration. Leukapheresis began once the blood CD34+ number reached 10 cells/mcl. Patients received consecutive days of leukapheresis, with the goal of collecting > 5 x 106 CD34+cells/kg. The collection process, concentration and storage of PBSC were similar for all patients. Briefly, a 4-blood volume leukapheresis PBSC collection was performed daily using a COBE Spectra cell separator (COBE BCT, Lakewood, CO). Collected cells were concentrated and cryopreserved. Cells were frozen in Cryocyte freezing bags (Nexell Therapeutics Inc.) in a controlled rate freezer (Custom BioGenic Systems, Shelby Township, MI). At the conclusion of this freezing, the cells were transferred to the vapor phase of a monitored liquid nitrogen freezer (CryoPlus III, Forma Scientific, Marietta, OH) at a temperature of -120 0C or below.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Cyclophosphamide, Hematopoietic, Stem Cell, Mobilization, Hematologic Malignancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 2: Cyclophosphamide 3 gms/m(2)
Arm Type
Active Comparator
Arm Description
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Arm Title
Arm 1: 1.5 gms/m(2) Cyclophosphamide
Arm Type
Experimental
Arm Description
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan, Cytoxan, Neosar, Procytox, Revimmune, Cytophosphane
Intervention Description
Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
Primary Outcome Measure Information:
Title
Number of Nucleated Cells Collected Within the Apheresis Products
Description
the investigator will identify the number of cells collected within the apheresis products
Time Frame
6 weeks
Title
Number of CD34+ Cells Collected Within the Apheresis Products
Description
the investigator will identify the number of CD34+ cells collected within the apheresis products
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Resource Utilization - Transfusions of Red Blood Cells
Description
Resources used during the mobilization and apheresis processes will be captured.
Time Frame
participants will be followed approximately 6 weeks following initiation of treatment
Title
Resource Utilization- Transfusion of Platelets
Description
Resources used during the mobilization and apheresis processes will be captured.
Time Frame
participants will be followed approximately 6 weeks following initiation of treatment
Title
Resource Utilization- Hospitalizations
Description
Resources used during the mobilization and apheresis processes will be captured.
Time Frame
participants will be followed approximately 6 weeks following initiation of treatment
Title
Resource Utilization- Incidence of Febrile Neutropenia
Description
Resources used during the mobilization and apheresis processes will be captured.
Time Frame
participants will be followed approximately 6 weeks following initiation of treatment
Title
Toxicities During the Mobilization and Apheresis Processes
Description
Toxicities during the mobilization and apheresis processes Grade 3 and higher
Time Frame
participants will be followed approximately 6 weeks following initiation of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients must have a pathologic diagnosis of one of the following malignancies:
Non-Hodgkin's Lymphoma, including B- and T-cell lymphoma Multiple Myeloma or another plasma cell dyscrasia (Waldenstrom, Amyloidosis)
The patient must be approved for transplant by the treating Transplant physician.
This must be the patient's FIRST mobilization attempt.
Patients are eligible if an autologous transplant is planned within approximately 12 months from the time of collection of cells.
Prior Treatment: No previous cytotoxic chemotherapy within 4 weeks prior to initiation of therapy. (This does not include immunomodulatory drugs (IMiDs), proteasome inhibitors, monoclonal antibodies or steroids.)
No radiation within 4 weeks of mobilization attempt.
Age >18, and < 75 years
No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival.
Informed consent must be signed prior to the treatment. Patients must willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. (Human protection committee approval of this protocol and a consent form is required.)
Exclusion Criteria:
Medical, social, or psychological factors that would prevent the patient from receiving or cooperating with the full course of therapy.
Documented hypersensitivity to any of the drugs used in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Meehan, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
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