Hematologic MalignanciesPhase 2NCT02139280
Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
A Phase 2 study testing Cyclophosphamide in people with Hematologic Malignancies, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
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- 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.)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
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.
Read the 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.
- Conditions
- Hematologic Malignancies
- Being tested
- Cyclophosphamide
- Keywords
- Cyclophosphamide, Hematopoietic, Stem Cell, Mobilization, Hematologic Malignancy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Endoxan, Cytoxan, Neosar, Procytox
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2: Cyclophosphamide 3 gms/m(2) | Active comparator | 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). Receives: Drug: Cyclophosphamide |
| Arm 1: 1.5 gms/m(2) Cyclophosphamide | Experimental | 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). Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Nucleated Cells Collected Within the Apheresis Products
the investigator will identify the number of cells collected within the apheresis products
Measured: 6 weeks
Number of CD34+ Cells Collected Within the Apheresis Products
the investigator will identify the number of CD34+ cells collected within the apheresis products
Measured: 6 weeks
Secondary outcomes (5)
Resource Utilization - Transfusions of Red Blood Cells
Resources used during the mobilization and apheresis processes will be captured.
Measured: participants will be followed approximately 6 weeks following initiation of treatment
Resource Utilization- Transfusion of Platelets
Resources used during the mobilization and apheresis processes will be captured.
Measured: participants will be followed approximately 6 weeks following initiation of treatment
Resource Utilization- Hospitalizations
Resources used during the mobilization and apheresis processes will be captured.
Measured: participants will be followed approximately 6 weeks following initiation of treatment
Resource Utilization- Incidence of Febrile Neutropenia
Resources used during the mobilization and apheresis processes will be captured.
Measured: participants will be followed approximately 6 weeks following initiation of treatment
Toxicities During the Mobilization and Apheresis Processes
Toxicities during the mobilization and apheresis processes Grade 3 and higher
Measured: participants will be followed approximately 6 weeks following initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Meehan, Dartmouth-Hitchcock Medical Center
- Investigators
- Kenneth Meehan, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139280
- Sponsor's protocol ID
- D13179
- Status last verified
- Jan 2021
- First submitted
- 3 Mar 2014
- Last updated
- 16 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT02139280
- Acronym / sponsor ID
- D13179
- Conditions
- Hematologic Malignancies
- Keywords
- Cyclophosphamide, Hematopoietic, Stem Cell, Mobilization, Hematologic Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 16 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2: Cyclophosphamide 3 gms/m(2) | Active comparator | Drug: CyclophosphamidePatients 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 1: 1.5 gms/m(2) Cyclophosphamide | Experimental | Drug: CyclophosphamidePatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: Endoxan, Cytoxan, Neosar, ProcytoxMechanism 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. | Drug | Arm 1: 1.5 gms/m(2) Cyclophosphamide, Arm 2: Cyclophosphamide 3 gms/m(2) |
Primary outcome
Number of Nucleated Cells Collected Within the Apheresis Products
Time frame: 6 weeks
the investigator will identify the number of cells collected within the apheresis products
Number of CD34+ Cells Collected Within the Apheresis Products
Time frame: 6 weeks
the investigator will identify the number of CD34+ cells collected within the apheresis products
5 secondary outcomes
Resource Utilization - Transfusions of Red Blood Cells
Time frame: participants will be followed approximately 6 weeks following initiation of treatment
Resource Utilization- Transfusion of Platelets
Time frame: participants will be followed approximately 6 weeks following initiation of treatment
Resource Utilization- Hospitalizations
Time frame: participants will be followed approximately 6 weeks following initiation of treatment
Resource Utilization- Incidence of Febrile Neutropenia
Time frame: participants will be followed approximately 6 weeks following initiation of treatment
Toxicities During the Mobilization and Apheresis Processes
Time frame: participants will be followed approximately 6 weeks following initiation of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Meehan, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide in people with Hematologic Malignancies, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Nucleated Cells Collected Within the Apheresis Products (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.