Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01630564
• Other study ID #: 2011-1178
• Secondary ID: NCI-2013-0038520
• Status: Terminated
• Phase: Phase 1
• Start date: March 11, 2013
• Est. completion date: May 30, 2018

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Biological:
• Aldesleukin
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin

Procedure:
• Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin

Biological:
• Umbilical Cord Blood-Derived Lymphocyte Therapy
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	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.	Up to day 45
Secondary	Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall		Up to day 100
Secondary	Numbers of patients treated at the MTD with grade 2-4 GVHD	Estimated with an exact 95% binomial confidence interval.	Up to day 100
Secondary	Proportion of patients with remission post-infusion	Estimated with an exact 95% binomial confidence interval.	Up to day 100
Secondary	Proportion of patients achieving chimerism post-infusion	Estimated with an exact 95% binomial confidence interval.	Up to day 100
Secondary	Proportion of patients with cytopenia post-infusion	Estimated with an exact 95% binomial confidence interval.	Up to day 100
Secondary	Proportion of patients that relapse after infusion	Estimated with an exact 95% binomial confidence interval.	Up to day 100
Secondary	Disease-free survival	Estimated with the Kaplan-Meier product limit estimator.	Up to day 100

External Links

•   MD Anderson Cancer Center Website