Clinical trial NCT02139280: Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Official title: A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematologic Malignancies
Keywords: Cyclophosphamide
Hematopoietic
Stem Cell
Mobilization
Hematologic Malignancy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

The time to collection of autologous hematopoietic stem cells was ten to twelve days following cyclophosphamide and daily filgrastim. Peripheral blood CD34+ cell numbers were examined beginning ten days after cyclophosphamide administration. Leukapheresis began once the blood CD34+ number reached 10 cells/mcl. Patients received consecutive days of leukapheresis, with the goal of collecting \> 5 x 106 CD34+cells/kg. The collection process, concentration and storage of PBSC were similar for all patients. Briefly, a 4-blood volume leukapheresis PBSC collection was performed daily using a COBE Spectra cell separator (COBE BCT, Lakewood, CO). Collected cells were concentrated and cryopreserved. Cells were frozen in Cryocyte freezing bags (Nexell Therapeutics Inc.) in a controlled rate freezer (Custom BioGenic Systems, Shelby Township, MI). At the conclusion of this freezing, the cells were transferred to the vapor phase of a monitored liquid nitrogen freezer (CryoPlus III, Forma Scientific, Marietta, OH) at a temperature of -120 0C or below.

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.

Primary outcomes:
measure: Number of Nucleated Cells Collected Within the Apheresis Products
timeFrame: 6 weeks
measure: Number of CD34+ Cells Collected Within the Apheresis Products
timeFrame: 6 weeks
Secondary outcomes:
measure: Resource Utilization - Transfusions of Red Blood Cells
timeFrame: participants will be followed approximately 6 weeks following initiation of treatment
measure: Resource Utilization- Transfusion of Platelets
timeFrame: participants will be followed approximately 6 weeks following initiation of treatment
measure: Resource Utilization- Hospitalizations
timeFrame: participants will be followed approximately 6 weeks following initiation of treatment
measure: Resource Utilization- Incidence of Febrile Neutropenia
timeFrame: participants will be followed approximately 6 weeks following initiation of treatment
measure: Toxicities During the Mobilization and Apheresis Processes
timeFrame: participants will be followed approximately 6 weeks following initiation of treatment
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Kenneth Meehan, MD
role: PRINCIPAL_INVESTIGATOR
References: