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Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy

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ClinicalTrials.gov Identifier: NCT02139280
Recruitment Status : Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth Meehan, Dartmouth-Hitchcock Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: Cyclophosphamide Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Study Start Date : December 2013
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : September 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 2: Cyclophosphamide 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 3 gms/m(2).
 Drug: Cyclophosphamide
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.
Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • Cytophosphane
Experimental: Arm 1: 1.5 gms/m(2) Cyclophosphamide
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).
 Drug: Cyclophosphamide
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.
Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • Cytophosphane


Outcome Measures
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Primary Outcome Measures :
  1. Cyclophosphamide Dose [ Time Frame: 6 weeks ]
    To define the primary objective, we will identify the number and types of cells collected within the apheresis products and characterize the details of the apheresis process.


Secondary Outcome Measures :
  1. Resource Utilization [ Time Frame: participants will be followed approximately 6 weeks following initiation of treatment ]

    Resources used during the mobilization and apheresis processes will be captured. Resources include:

    • Transfusions of red blood cells
    • Transfusion of platelets
    • Hospitalizations
    • Incidence of febrile neutropenia


Other Outcome Measures:
  1. Hematological Laboratory Determinations [ Time Frame: participants will be followed approximately 6 weeks following initiation of treatment ]
    Determine the post-transplant engraftment of neutrophils and platelets. 2.3.2 Qualitative and quantitative analyses of mobilized lymphocytes (Elective-pending funding).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139280


Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Kenneth Meehan, MD Dartmouth-Hitchcock Medical Center
More Information
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Responsible Party: Kenneth Meehan, Director, Bone Marrow Transplant Program, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02139280    
Other Study ID Numbers: D13179
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Keywords provided by Kenneth Meehan, Dartmouth-Hitchcock Medical Center:
Cyclophosphamide
Hematopoietic
Stem Cell
Mobilization
Hematologic Malignancy
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists