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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

Page last updated: August 23, 2015

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