Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase I Study of Cord Blood Lymphocyte Infusion

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

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
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


Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01630564

Contact: Simrit Parmar, MD 713-792-8750

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

Additional Information:
No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
Blood And Marrow Transplantation
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 processed this record on March 03, 2015