search
Back to results

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

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aldesleukin
Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
Umbilical Cord Blood-Derived Lymphocyte Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (T-cell infusion)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall
Numbers of patients treated at the MTD with grade 2-4 GVHD
Estimated with an exact 95% binomial confidence interval.
Proportion of patients with remission post-infusion
Estimated with an exact 95% binomial confidence interval.
Proportion of patients achieving chimerism post-infusion
Estimated with an exact 95% binomial confidence interval.
Proportion of patients with cytopenia post-infusion
Estimated with an exact 95% binomial confidence interval.
Proportion of patients that relapse after infusion
Estimated with an exact 95% binomial confidence interval.
Disease-free survival
Estimated with the Kaplan-Meier product limit estimator.

Full Information

First Posted
June 26, 2012
Last Updated
November 8, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01630564
Brief Title
Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies
Official Title
Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Study Start Date
March 11, 2013 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (T-cell infusion)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Aldesleukin
Other Intervention Name(s)
125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2
Intervention Description
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Intervention Type
Procedure
Intervention Name(s)
Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
Intervention Description
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood-Derived Lymphocyte Therapy
Intervention Description
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Primary Outcome Measure Information:
Title
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%
Description
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.
Time Frame
Up to day 45
Secondary Outcome Measure Information:
Title
Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall
Time Frame
Up to day 100
Title
Numbers of patients treated at the MTD with grade 2-4 GVHD
Description
Estimated with an exact 95% binomial confidence interval.
Time Frame
Up to day 100
Title
Proportion of patients with remission post-infusion
Description
Estimated with an exact 95% binomial confidence interval.
Time Frame
Up to day 100
Title
Proportion of patients achieving chimerism post-infusion
Description
Estimated with an exact 95% binomial confidence interval.
Time Frame
Up to day 100
Title
Proportion of patients with cytopenia post-infusion
Description
Estimated with an exact 95% binomial confidence interval.
Time Frame
Up to day 100
Title
Proportion of patients that relapse after infusion
Description
Estimated with an exact 95% binomial confidence interval.
Time Frame
Up to day 100
Title
Disease-free survival
Description
Estimated with the Kaplan-Meier product limit estimator.
Time Frame
Up to day 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sairah Ahmed
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs