Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Interventions
- Biological: AldesleukinProcedure: Ex Vivo-Expanded Cord Blood Progenitor Cell InfusionBiological: Umbilical Cord Blood-Derived Lymphocyte Therapy
- Registration Number
- NCT01630564
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
This phase I trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. Removing the T cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.
- Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the safety and maximum tolerated dose (MTD) of infusion of ex vivo expanded cord blood T cells (CLI), in cord blood (CB) transplant recipients with relapsed hematological malignancies.
SECONDARY OBJECTIVES:
I. To determine the complete remission rate and overall response as a result of CLI infusion.
II. To determine the effect of CLI infusion on the chimerism. III. To evaluate the incidence rate and grade of acute graft-versus-host disease (GvHD) after CLI infusion.
IV. To determine the disease-free survival, cytopenia rate, relapse incidence after CLI infusion.
OUTLINE: This is a dose-escalation study of ex vivo-expanded T-cells.
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
After completion of study treatment, patients are followed up for 100 days.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Umbilical cord blood (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
- 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
- Performance score of at least 80% by Karnofsky or performance status (PS) < 3 (Eastern Cooperative Oncology Group [ECOG]) (age >= 12 years), or Lansky Play-performance scale of at least 60% or greater (age < 12 years)
- Negative beta human chorionic gonadotropin (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
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent
- Human immunodeficiency virus (HIV) positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)
- Patients with active (untreated) central nervous system (CNS) disease
- Any active GVHD
- Active invasive infections
- Pregnant or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (T-cell infusion) Aldesleukin Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins. Treatment (T-cell infusion) Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins. Treatment (T-cell infusion) Umbilical Cord Blood-Derived Lymphocyte Therapy Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) of ex vivo expanded T-cells defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30% Up to day 45 Dose limiting toxicity is defined as grade IV graft-versus-host disease (GVHD), grades 3-4 acute GVHD occurring within 45 days of the study T cell infusion, grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic), grade 4 cytopenia, or any grade 4 or 5 organ based (non-hematologic) toxicity.
- Secondary Outcome Measures
Name Time Method Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall Up to day 100 Numbers of patients treated at the MTD with grade 2-4 GVHD Up to day 100 Estimated with an exact 95% binomial confidence interval.
Proportion of patients with remission post-infusion Up to day 100 Estimated with an exact 95% binomial confidence interval.
Proportion of patients achieving chimerism post-infusion Up to day 100 Estimated with an exact 95% binomial confidence interval.
Proportion of patients with cytopenia post-infusion Up to day 100 Estimated with an exact 95% binomial confidence interval.
Proportion of patients that relapse after infusion Up to day 100 Estimated with an exact 95% binomial confidence interval.
Disease-free survival Up to day 100 Estimated with the Kaplan-Meier product limit estimator.
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States