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



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:December 2013
End Date:December 2019
Contact:Bridget Labrie
Email:bridget.m.labrie@hitchcock.org
Phone:603-650-6227

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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.

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.

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.
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Kenneth Meehan, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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