Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia (NCT00245115) | Clinical Trial Compass
TerminatedPhase 1
Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia
Stopped: Expiration of study supply
United States7 participantsStarted 2005-10
Plain-language summary
RATIONALE: Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected. Treating stem cells collected from the patient's blood or bone marrow with chemotherapy in the laboratory removes any remaining cancer cells. Chemotherapy or radiation therapy is given to the patient to prepare the bone marrow for stem cell transplant. The treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This clinical trial is studying how well an autologous peripheral stem cell or bone marrow transplant using laboratory-treated cells works in treating patients with acute leukemia.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of acute leukemia meeting 1 of the following criteria:
* High-risk acute myeloid leukemia (AML) in first complete remission (CR) with no matched family donor available, including any of the following types:
* Secondary AML
* AML with chromosome 5 or 7 abnormalities
* AML with trisomy 8
* AML with 6;9 chromosomal translocation
* AML with 11q23 chromosomal abnormality
* AML with multiple or complex chromosomal abnormalities
* AML with FAB M6 or M7
* AML in second CR (CR2) with no eligible HLA-identical sibling donor available
* High-risk acute lymphoblastic leukemia (ALL) with no eligible HLA-identical sibling donor available, including any of the following types:
* Philadelphia chromosome-positive ALL
* ALL with 11q23 chromosomal abnormality
* ALL in CR2
* Eligible for and willing to undergo bone marrow transplantation
* No intermediate- or good-risk acute leukemia in CR1
Exclusion Criteria
* Availability of a suitable matched HLA-identical sibling marrow donor
* Intermediate or good risk acute leukemia in CR1 (39)
* Age greater than 70
* Weight less than 10 kg
* Any risk of pregnancy - all female patients must have an effective form of contraception or be infertile due to hysterectomy, fallopian tube, surgery or premature menopause.
* HIV Infection: Patients must be HIV negative for inclusion.
* Poor organ function as defined in the BMT Policies and Procedures Manual.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients infused with Mf-treated cells with successful expansion
Timeframe: 2 weeks
Trial details
NCT IDNCT00245115
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins