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

Description

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.

Study Start Date

December 2013

Estimated Completion Date

December 2016

Interventions

  • Drug: Cyclophosphamide

Specialties

  • Oncology: Leukemia/Lymphoma,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Clinical Pharmacology,Hematology/Oncology

MeSH Terms

  • Cyclophosphamide
  • Hematologic Neoplasms

Study ID

Dartmouth-Hitchcock Medical Center -- D13179

Status

Unknown

Trial ID

NCT02139280

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

40

Sponsor

Dartmouth-Hitchcock Medical Center

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire 105.5 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.