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

NCT01630564 | Terminated Phase 1 FDA Drug

• 3 other identifiers: 2011-1178NCI-2013-00385P30CA016672
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (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%

  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 Outcomes (7)

• 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

• Proportion of patients with remission post-infusion

  Up to day 100

• Proportion of patients achieving chimerism post-infusion

  Up to day 100

• Proportion of patients with cytopenia post-infusion

  Up to day 100

Study Arms (1)

Treatment (T-cell infusion)

EXPERIMENTAL

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; Procedure: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion; Biological: Umbilical Cord Blood-Derived Lymphocyte Therapy

Interventions

Aldesleukin BIOLOGICAL

Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin

Also known as: 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2

Treatment (T-cell infusion)

Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion PROCEDURE

Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin

Treatment (T-cell infusion)

Umbilical Cord Blood-Derived Lymphocyte Therapy BIOLOGICAL

Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin

Treatment (T-cell infusion)

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sairah Ahmed

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: March 11, 2013
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

US (1)