T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases

This study has been terminated.

(slow accrual)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Jaroslaw Maciejewski, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT00589602

First received: January 1, 2008

Last updated: April 18, 2017

Last verified: April 2017

History of Changes

Results First Received: September 20, 2016

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: No masking; Primary Purpose: Treatment
Conditions:	Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Malignant Plasma Cell Neoplasms Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Secondary Myelofibrosis
Interventions:	Procedure: peripheral blood lymphocyte therapy Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation (TBI)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from local hospital from January, 2006 through January, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
T-Cell Depletion Transplant	Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT. Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation' peripheral blood lymphocyte therapy: T-cell depletion cyclophosphamide: T-cell depletion tacrolimus: T-cell depletion allogeneic hematopoietic stem cell transplantation: T-cell depletion peripheral blood stem cell transplantation: T-cell depletion total-body irradiation: T-cell depletion

Description

T-Cell Depletion Transplant

Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.

Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'

peripheral blood lymphocyte therapy: T-cell depletion

cyclophosphamide: T-cell depletion

tacrolimus: T-cell depletion

allogeneic hematopoietic stem cell transplantation: T-cell depletion

peripheral blood stem cell transplantation: T-cell depletion

total-body irradiation: T-cell depletion

Participant Flow: Overall Study

	T-Cell Depletion Transplant
STARTED	13
COMPLETED	12
NOT COMPLETED	1
Did not collect enough CD34+ cells	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
T-Cell Depletion Transplant	Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT. Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation' peripheral blood lymphocyte therapy: T-cell depletion cyclophosphamide: T-cell depletion tacrolimus: T-cell depletion allogeneic hematopoietic stem cell transplantation: T-cell depletion peripheral blood stem cell transplantation: T-cell depletion total-body irradiation: T-cell depletion

Description

T-Cell Depletion Transplant

Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'

peripheral blood lymphocyte therapy: T-cell depletion

cyclophosphamide: T-cell depletion

tacrolimus: T-cell depletion

allogeneic hematopoietic stem cell transplantation: T-cell depletion

peripheral blood stem cell transplantation: T-cell depletion

total-body irradiation: T-cell depletion

Baseline Measures

	T-Cell Depletion Transplant
Overall Participants Analyzed [Units: Participants]	13

Age [Units: Participants] Count of Participants
<=18 years	1 7.7%
Between 18 and 65 years	12 92.3%
>=65 years	0 0.0%

Age [Units: Years] Median (Full Range)	46 (18 to 58)

Sex: Female, Male [Units: Participants] Count of Participants
Female	7 53.8%
Male	6 46.2%

Region of Enrollment [Units: Participants]
United States	13

Outcome Measures

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1. Primary:

Treatment-related Mortality (TRM) [ Time Frame: 180 days after transplant ]

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2. Secondary:

The Rate of Acute Graft Versus Host Disease (GVHD) [ Time Frame: D+100 from transplant ]

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3. Secondary:

Number of Participants With Duration of Absolute Neutropenia [ Time Frame: D+100 from transplant ]

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4. Secondary:

Number of Participants Able to Receive T-cell Add Backs [ Time Frame: through D+100 ]

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5. Secondary:

Number of Participants With Relapse-free Survival [ Time Frame: after 7 years of follow up ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Jarek Maciejewski, MD
Organization: Cleveland Clinic
phone: 216-445-5962
e-mail: maciejj@ccf.org

Responsible Party:	Jaroslaw Maciejewski, The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00589602 History of Changes
Other Study ID Numbers:	CCF-6501 P30CA043703 ( U.S. NIH Grant/Contract )
Study First Received:	January 1, 2008
Results First Received:	September 20, 2016
Last Updated:	April 18, 2017

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