Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

Leukemia Clinical Trial

Official title:

Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186342
• Other study ID #: BMT45
• Secondary ID: 75274BMT45
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 13, 2012
• Start date: September 1992
• Est. completion date: January 2009

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Disease
• Blood and Marrow Transplant (BMT)
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic
• Myelodysplastic Syndromes
• Myelodysplastic Syndromes (MDS)
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Procedure:
• ablative allogeneic hematopoietic cell transplantation

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tolerability		unknown	Yes
Primary	efficacy of therapy		unknown	No
Secondary	compare efficacy of this treatment to historical controls		unknown	No