Phase I Study of Cord Blood Lymphocyte Infusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01630564
First received: June 26, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Myeloproliferative Diseases
Drug: Ex vivo Expanded T Cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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


Estimated Enrollment: 18
Study Start Date: March 2013
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630564

Contacts
Contact: Simrit Parmar, MD 713-792-8750

Locations
United States, Texas
UT MD Andreson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Simrit Parmar, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01630564     History of Changes
Other Study ID Numbers: 2011-1178, NCI-2013-00385
Study First Received: June 26, 2012
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

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
Lymphoma
Leukemia
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014