A Phase 1 interventional study of Cyclophosphamide and Fludarabine in Blood And Marrow Transplantation, Leukemia and Lymphoma, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
The goal of this clinical research study is to learn if researchers can successfully and safely give patients who have had a stem cell transplant an infusion of white blood cells (called T-cells) that have been collected from an unrelated person, and that have been genetically changed. The process of changing the DNA (genetic material) of these T-cells is called "gene transfer." The gene transfer involves drawing blood from an unrelated donor, separating out T cells using a machine, changing the cells' DNA in the laboratory, and returning the genetically changed cells back to the body. T-cells are a type of white blood cell that fight infection. The type of gene transfer being used in this study is designed to help your T-cells to better fight cancer by targeting a chemical marker that is found on certain cancer cells.
Researchers want to learn if these genetically-changed T-cells can help to control B-cell leukemia or lymphoma after a stem cell transplant.
Researchers want to find out the highest tolerable dose of these T-cells that can be given to patients with relapsed leukemia or lymphoma.
Study Plan:
This study has 2 steps: chemotherapy and gene transfer.
The chemotherapy combination in this study (fludarabine and cyclophosphamide) is given to try to help the T-cells work better.
Study Groups:
If the participant is found to be eligible to take part in this study, the participant will be assigned to a dose level of T-cells based on when the participant joined this study. The first group of 3 participants will receive the lowest dose of T-cells. Each new group will receive a higher dose of T-cells than the group before it, if no intolerable side effects were seen. Up to 6 dose levels of T-cells will be tested.
Chemotherapy and Gene Transfer:
Sometime between 2-7 days after chemotherapy ends, the participant will receive the T cell infusion by vein over 15-30 minutes. The infusion will be divided into 2 parts at least 24 hours apart. During and after the infusion, your vital signs will be checked.
the participant will be given standard drugs to help decrease the risk of side effects. the participant may ask the study staff for information about how the drugs are given and their risks.
If the doctor thinks it is needed based on the status of the disease, the participant may receive up to 2 more courses of this study therapy given at least 6 weeks apart.
Study Tests:
the participant will be in the hospital from Day -8 through 2 days after the stem cell transplant. Every day while you are in the hospital, blood (about 2 teaspoons) will be drawn for routine tests.
About 1 week before the T-cell infusion, the following tests and procedures will be performed. These tests will not be repeated again if the T-cell infusion is repeated.
Before the T-cell infusion and up to 2 times within 24 hours after the T-cell infusion, blood (about 4 tablespoons) will be drawn to measure your body's response to the T cell infusion.
Follow-Up:
Within about 12 hours, 3 days, 1 week, and 2 weeks after the T-cell infusion, the following tests and procedures will be performed. These tests will be repeated again if the T-cell infusion is repeated.
Up to 3 times during the first 7 days after the T-cell infusion, blood (about 4 tablespoons) will be drawn to measure your body's response to the T cell infusion.
Every 2 weeks during the first month, then 1 time a month until 1 year after the T-cell infusion, blood (2 teaspoons) will be drawn for tests of your immune system.
At about 6 weeks, and then 1, 2, and 3 months after the T-cell infusion:
At about 3 months after the T-cell infusion, blood (about 2 teaspoons) will be drawn to check for HAMA, and you will have breathing tests to check your lung function.
At least 1 time during the 3 months after the T-cell infusion:
If the disease comes back or a side effect occurs during the 12 months after the T-cell infusion, you may be asked to return for additional follow-up visits if the doctor thinks it is needed.
Length of Study:
the participant may receive up to 3 courses of study therapy. the participant will no longer be able to receive the study therapy if the disease gets worse, if infections or intolerable side effects occur, or if the participant is unable to follow study directions. the participant may withdraw from the study at any time, but the infusion of the T cells is not necessarily reversible and these types of products have the potential for long-term survival in the body. If the participant withdraw from the study it will only include withdrawal from any procedures specifically preformed for this protocol and long-term follow-up. Please note, long-term follow-up is important for your safety.
Your participation on the study will be over once the participant have completed the follow-up visits.
Long-Term Follow-Up:
For safety reasons, the FDA requires patients receiving gene transfer to have long-term follow-up for at least 15 years after receiving the gene transfer. The participant will be asked to sign a separate consent form (Protocol 2006-0676) for long-term follow up that begins 1 year after this study ends.
This is an investigational study. The chemotherapy drugs in this study are commercially available and FDA approved for the treatment of B-cell leukemia or lymphoma. The gene transfer (infusion with genetically modified T-cells) is not commercially available or FDA approved. It is currently being used for research purposes only.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
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Exclusion Criteria:
Cyclophosphamide 60 mg/kg by vein for 2 consecutive days, followed by Fludarabine at 25 mg/m2/day by vein for 5 consecutive days. Fludarabine dose calculated per adjusted ideal body weight. T-cell product divided into 2 portions. Up to 25% of the genetically modified cells given on first day, with plan to infuse up to 75% of the remaining T-cell dose no sooner than 24 hours after completion of first portion. Second portion should not be given later than 72 hours after first portion. First group of 3 participants receive lowest dose of T-cells. Each new group receive a higher dose of T-cells than the group before it, if no intolerable side effects were seen. Up to 6 dose levels of T-cells will be tested.
Drug: Cyclophosphamide · Drug: Fludarabine · Procedure: T-Cell Infusion
60 mg/kg by vein on Days -8 and -7.
Also known as: Cytoxan, Neosar
25 mg/m2 by vein on Days -6 to -2.
Also known as: Fludarabine Phosphate, Fludara
T-cells infused no sooner than 48 hours and no later than 1 week post completion of chemotherapy on Day 0.
Maximum Tolerated Dose (MTD) of CD19-Specific T Cells
Maximum tolerated dose (MTD) is highest dose level 6 patients treated, with at most 2 experiencing dose limiting toxicity (DLT). DLT defined as new adverse event attributable to CD19-specific T cells of grade \>3 that lasts for more than 3 days, and related to CD19-specific T cells within 30 days of an infusion. Grade 3/4 graft versus host disease (GVHD) occurring within 6 weeks of CD19-specific T cells administration, also a DLT. Graft failure following CD19-specific T cells administration considered DLT.
Time frame: 12 hours
No study locations are listed for this record.
Ran from Oct 2014 to primary completion in Oct 2014, 0 months.
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This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclophosphamide · Fludarabine