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

NCT02139280 | Completed Phase 2 Results DMC

• 1 other identifier: D13179
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies

Keywords

Cyclophosphamide; Hematopoietic; Stem Cell; Mobilization; Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• Number of Nucleated Cells Collected Within the Apheresis Products

  the investigator will identify the number of cells collected within the apheresis products

  6 weeks

• Number of CD34+ Cells Collected Within the Apheresis Products

  the investigator will identify the number of CD34+ cells collected within the apheresis products

  6 weeks

Secondary Outcomes (5)

• Resource Utilization - Transfusions of Red Blood Cells

  participants will be followed approximately 6 weeks following initiation of treatment

• Resource Utilization- Transfusion of Platelets

  participants will be followed approximately 6 weeks following initiation of treatment

• Resource Utilization- Hospitalizations

  participants will be followed approximately 6 weeks following initiation of treatment

• Resource Utilization- Incidence of Febrile Neutropenia

  participants will be followed approximately 6 weeks following initiation of treatment

• Toxicities During the Mobilization and Apheresis Processes

  participants will be followed approximately 6 weeks following initiation of treatment

Study Arms (2)

Arm 2: Cyclophosphamide 3 gms/m(2)

ACTIVE COMPARATOR

Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).

Drug: Cyclophosphamide

Arm 1: 1.5 gms/m(2) Cyclophosphamide

EXPERIMENTAL

Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.

Also known as: Endoxan, Cytoxan, Neosar, Procytox, Revimmune, Cytophosphane

Arm 1: 1.5 gms/m(2) Cyclophosphamide; Arm 2: Cyclophosphamide 3 gms/m(2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Kenneth Meehan, MD
• Organization: Dartmouth-Hitchcock Medical Center

Kenneth.R.Meehan@hitchcock.org

603.650.4628

Study Officials

• Kenneth Meehan, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bone Marrow Transplant Program

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: May 15, 2014
• Study Start: December 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2020
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-01

Locations

US (1)