Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

Not Applicable

Completed

• Conditions: Acute Disease; Myelodysplastic Syndromes; Myeloproliferative Disorders; Blood and Marrow Transplant (BMT); Myelodysplastic Syndromes (MDS); Leukemia, Myeloid, Chronic; Leukemia
• Interventions: Procedure: ablative allogeneic hematopoietic cell transplantation

• Registration Number: NCT00186342
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study Start: 1992-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.

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.

4. Patients with secondary myelodysplasia following cytotoxic chemotherapy.

Exclusion Criteria

• Organ dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CIK cell	ablative allogeneic hematopoietic cell transplantation	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.

Primary Outcome Measures

Name	Time	Method
efficacy of therapy
tolerability

Secondary Outcome Measures

Name	Time	Method
compare efficacy of this treatment to historical controls

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States