Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: Cyclophosphamide
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.
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cyclophosphamide; Hematopoietic; Stem Cell; Mobilization; Hematologic Malignancy

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.
    

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.