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Phase I Study of Cord Blood Lymphocyte Infusion

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ClinicalTrials.gov Identifier: NCT01630564
Recruitment Status : Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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).

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Myeloproliferative Diseases Drug: Ex vivo Expanded T Cells Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients
Actual Study Start Date : March 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ex vivo Expanded T Cell Infusion
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.
Drug: Ex vivo Expanded T Cells
Starting Dose 1: 1 * 10e6 T cells/kg infused through central venous catheter (CVC).



Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of ex vivo Expanded Cord Blood T Cells [ Time Frame: 30 days ]
    Maximum tolerated dose (MTD) defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30%.



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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630564


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Simrit Parmar, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01630564     History of Changes
Other Study ID Numbers: 2011-1178
NCI-2013-00385 ( Registry Identifier: NCI CTRP )
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Blood And Marrow Transplantation
Leukemia
Lymphoma
Myeloproliferative Diseases
Relapsed hematological malignancies
Post-Transplant Relapsed Patients
Cord Blood Lymphocyte Infusion
Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion

Additional relevant MeSH terms:
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases