Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00587054

First received: December 21, 2007

Last updated: January 20, 2017

Last verified: January 2017

History of Changes

Results First Received: December 22, 2015

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Allogeneic Stem Cell Transplant Leukemia Non-Hodgkins Lymphoblastic Lymphoma Myelodysplastic Syndrome Paroxysmal Nocturnal Hemoglobinuria (PNH)
Intervention:	Drug: cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant

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
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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
Transplant Patients	Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine

Participant Flow: Overall Study

	Transplant Patients
STARTED	129
COMPLETED	120
NOT COMPLETED	9
Patient not treated	9

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
Transplant Patients	Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine

Baseline Measures

	Transplant Patients
Overall Participants Analyzed [Units: Participants]	129

Age [Units: Participants] Count of Participants
<=18 years	2 1.6%
Between 18 and 65 years	127 98.4%
>=65 years	0 0.0%

Sex: Female, Male [Units: Participants] Count of Participants
Female	51 39.5%
Male	78 60.5%

Outcome Measures

1. Primary:

Overall Survival of Transplant Patients [ Time Frame: up to 6 years ]

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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:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Ann Jakubowski
Organization: Memorial Sloan-Kettering Cancer Center
phone: 212-639-5013
e-mail: jakubowa@mskcc.org

Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00587054 History of Changes
Other Study ID Numbers:	01-070 CA23766 CA33049
Study First Received:	December 21, 2007
Results First Received:	December 22, 2015
Last Updated:	January 20, 2017

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