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

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ClinicalTrials.gov Identifier: NCT01630564
Recruitment Status : Terminated
First Posted : June 28, 2012
Last Update Posted : November 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Biological: Aldesleukin Procedure: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion Biological: Umbilical Cord Blood-Derived Lymphocyte Therapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 11, 2013
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aldesleukin

Arm Intervention/treatment
Experimental: Treatment (T-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.
Biological: Aldesleukin
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Other Names:
  • 125-L-Serine-2-133-interleukin 2
  • Proleukin
  • r-serHuIL-2
  • Recombinant Human IL-2
  • Recombinant Human Interleukin-2

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




Primary Outcome Measures :
  1. 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% [ Time Frame: 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 :
  1. Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall [ Time Frame: Up to day 100 ]
  2. Numbers of patients treated at the MTD with grade 2-4 GVHD [ Time Frame: Up to day 100 ]
    Estimated with an exact 95% binomial confidence interval.

  3. Proportion of patients with remission post-infusion [ Time Frame: Up to day 100 ]
    Estimated with an exact 95% binomial confidence interval.

  4. Proportion of patients achieving chimerism post-infusion [ Time Frame: Up to day 100 ]
    Estimated with an exact 95% binomial confidence interval.

  5. Proportion of patients with cytopenia post-infusion [ Time Frame: Up to day 100 ]
    Estimated with an exact 95% binomial confidence interval.

  6. Proportion of patients that relapse after infusion [ Time Frame: Up to day 100 ]
    Estimated with an exact 95% binomial confidence interval.

  7. Disease-free survival [ Time Frame: Up to day 100 ]
    Estimated with the Kaplan-Meier product limit estimator.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630564


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sairah Ahmed M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01630564    
Other Study ID Numbers: 2011-1178
NCI-2013-00385 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2011-1178 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents