Phase I Study of Cord Blood Lymphocyte Infusion

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 18
• Participant gender: Both

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Last Updated: 2016-09-07

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.