Phase 2
Completed N=54
Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Source: ClinicalTrials.gov NCT02139280 ↗Enrolled (actual)
54
Serious AEs
5.7%
Results posted
Feb 2021
Primary outcomePrimary: Number of Nucleated Cells Collected Within the Apheresis Products — 5.7; 3.8 cells x10e10
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Nucleated Cells Collected Within the Apheresis Products |
5.7; 3.8 | — |
| PRIMARY Number of CD34+ Cells Collected Within the Apheresis Products |
7; 10.5 | — |
| SECONDARY Resource Utilization - Transfusions of Red Blood Cells |
— | — |
| SECONDARY Resource Utilization- Transfusion of Platelets |
— | — |
| SECONDARY Resource Utilization- Hospitalizations |
1; 1 | — |
| SECONDARY Resource Utilization- Incidence of Febrile Neutropenia |
2; 2 | — |
| SECONDARY Toxicities During the Mobilization and Apheresis Processes |
4; 7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02139280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.