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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldesleukin | Biological | Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Estimated with an exact 95% binomial confidence interval. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sairah Ahmed | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion | Procedure | Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin |
|
| Umbilical Cord Blood-Derived Lymphocyte Therapy | Biological | Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin |
|
| Up to day 100 |
| Proportion of patients with remission post-infusion | Estimated with an exact 95% binomial confidence interval. | Up to day 100 |
| Proportion of patients achieving chimerism post-infusion | Estimated with an exact 95% binomial confidence interval. | Up to day 100 |
| Proportion of patients with cytopenia post-infusion | Estimated with an exact 95% binomial confidence interval. | Up to day 100 |
| Proportion of patients that relapse after infusion | Estimated with an exact 95% binomial confidence interval. | Up to day 100 |
| Disease-free survival | Estimated with the Kaplan-Meier product limit estimator. | Up to day 100 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
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