Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Information source: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hematologic Malignancies
Intervention: Cyclophosphamide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Dartmouth-Hitchcock Medical Center Official(s) and/or principal investigator(s): Kenneth Meehan, MD, Principal Investigator, Affiliation: Dartmouth-Hitchcock Medical Center
Overall contact: Eryn Bagley, Phone: 603-650-4035, Email: eryn.m.bagley@hitchcock.org
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.
Clinical Details
Official title: A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cyclophosphamide Dose
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Eryn Bagley, Phone: 603-650-4035, Email: eryn.m.bagley@hitchcock.org
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting Kenneth Meehan, MD, Principal Investigator
Additional Information
Starting date: December 2013
Last updated: July 14, 2015
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