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Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

NCT ID: NCT00186342

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-09-30

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).

Detailed Description

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To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.

Conditions

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Acute Disease Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Myeloproliferative Disorders Blood and Marrow Transplant (BMT) Myelodysplastic Syndromes (MDS) Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CIK cell

The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD.

Group Type EXPERIMENTAL

ablative allogeneic hematopoietic cell transplantation

Intervention Type PROCEDURE

Interventions

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ablative allogeneic hematopoietic cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

2\) Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.

3\) Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.
Minimum Eligible Age

51 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Robert Negrin

Professor of Lymphatic Research and Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert S Negrin

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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75274

Identifier Type: -

Identifier Source: secondary_id

BMT45

Identifier Type: -

Identifier Source: secondary_id

NCT00186342

Identifier Type: -

Identifier Source: secondary_id

BMT45

Identifier Type: -

Identifier Source: org_study_id