Overview

This trial is active, not recruiting.

Conditions leukemia, lymphoma, myeloproliferative diseases
Treatment ex vivo expanded t cells
Phase phase 1
Sponsor M.D. Anderson Cancer Center
Start date March 2013
End date March 2017
Trial size 18 participants
Trial identifier NCT01630564, 2011-1178, NCI-2013-00385

Summary

The goal of this clinical research study is to learn about the highest tolerated dose of T cells that can be safely given to patients whose cancer has returned after a umbilical cord blood transplant (UCBT).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Three patients enrolled at Starting Dose 1: 1 * 10e6 T cells/kg infused through central venous catheter (CVC). If no toxicities occur, next three patients enrolled at Dose 2, etc. If any patient develops stage IV graft versus host disease (GVHD), next patient treated at next lower dose. If patient is prescribed a higher dose but the lab is unable to produce this amount of cells, patient will be treated at a lower dose. This will continue for up to 3 dose levels, until the highest tolerable dose of cord blood is found.
ex vivo expanded t cells
Starting Dose 1: 1 * 10e6 T cells/kg infused through central venous catheter (CVC).

Primary Outcomes

Measure
Maximum tolerated dose (MTD) of ex vivo Expanded Cord Blood T Cells
time frame: 30 days

Eligibility Criteria

Male or female participants at least 6 months old.

Inclusion Criteria: 1. UCB recipients with underlying hematological malignancies presenting with post transplant relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant. 2. UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant. 3. Patient's Age Criteria: Age greater than 5 months old. Eligibility for pediatric patients will be determined in conjunction with an MDACC pediatrician. 4. Performance score of at least 80% by Karnofsky or PS < 3 (ECOG) (age >/= 12 years), or Lansky Play-Performance Scale of at least 60% or greater (age <12 years). 5. Negative Beta HCG or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study. 6. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent. Exclusion Criteria: 1. HIV positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant). 2. Patients with active (untreated) CNS disease. 3. Any active GVHD. 4. Active invasive infections. 5. Pregnant or breast-feeding.

Additional Information

Official title Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients
Principal investigator Simrit Parmar, MD
Description You have had a UCBT. A small amount of the previously infused cord blood was frozen. This saved cord blood will be treated at the MD Anderson Stem Cell Laboratory with interleukin-2 (IL-2) and clinical beads to produce and help generate the needed T cells. This will take about 2 weeks. When the product is ready, you will be given the expanded cord blood T cells as an infusion through your central venous catheter (CVC). Cord Blood T Cell Infusion: You will be assigned to a dose level of cord blood T cells based on when you joined this study. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue for up to 3 dose levels, until the highest tolerable dose of cord blood is found. You will receive the cord blood T cells through your CVC. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. Study Tests: Before the cord blood T cell infusion: - Your medical history will be recorded, and you will have a physical exam. - Blood (about 4-6 teaspoons) will be drawn for routine tests, to test for cytomegalovirus (CMV), and to see how well the transplant has taken. After the cord blood T cell infusion: - Your vital signs will be measured (blood pressure, heart rate, temperature, and breathing rate). - You will have a pulse oximetry test to check the amount of oxygen in your blood. For this test a clothespin-shaped clip will be placed on your finger for about 1 minute. One day after the cord blood T cell infusion: - You will have a physical exam. - You will be asked about how you are feeling and about any side effects you may be having. - You will be checked for possible reactions to the infusion, including graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted). - Blood (about 4-6 teaspoons) will be drawn for routine tests and to test for CMV. One time a week for the first 3 weeks after the cord blood T cell infusion: - Your medical history will be recorded, and you will have a physical exam. - You will be asked about how you are feeling and about any side effects you may be having. - You will be checked for possible reactions to the infusion, including GVHD. - Blood (4-6 teaspoons) will be drawn for routine tests and to test for CMV. At 1 month (+/- 7 days) after the cord blood T cell infusion: - Your medical history will be recorded, and you will have a physical exam. - You will be asked about how you are feeling and about any side effects you may be having. - You will be checked for possible reactions to the infusion, including GVHD. - Blood (about 4-6 teaspoons) will be drawn for routine tests, to test for CMV, and to learn if and how well the transplant has taken. - You may have a bone marrow biopsy/aspirate to check the status of the disease. To collect a bone marrow biopsy/aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle. - You may have imaging scans to check the status of the disease and/or to check for possible infections. End-of-Study Visit: At about 45 days (+/- 7 days) after the cord blood T cell infusion and when you are taken off study: - Your medical history will be recorded, and you will have a physical exam. - You will be asked about how you are feeling and about any side effects you may be having. - You will be checked for possible reactions to the infusion, including GVHD. - Blood (about 4-6 teaspoons) will be drawn for routine tests, to test for CMV, and to learn if and how well the transplant has taken. Length of Study: You will be on study for about 100 days after the cord blood T cell infusion. You may be taken off study early if the disease gets worse, if there is not enough cord blood to infuse, if it cannot be infused due to infection/contamination, if you have any intolerable side effects, or if you are unable to follow study directions. You should talk to the study doctor if you want to leave the study early. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant doctor decides it is needed. This is an investigational study. The cord blood T cell expansion procedure is not FDA approved or commercially available. It is currently being used for research purposes only. Up to 18 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.