Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT00186342

Collaborator

(none)

120

Enrollment

Location

Arm

196

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Disease Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Myeloproliferative Disorders Blood and Marrow Transplant (BMT) Myelodysplastic Syndromes (MDS) Leukemia	Procedure: ablative allogeneic hematopoietic cell transplantation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1992

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: ablative allogeneic hematopoietic cell transplantation

Arm

Intervention/Treatment

Experimental: 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.

Procedure: ablative allogeneic hematopoietic cell transplantation

Outcome Measures

Primary Outcome Measures

tolerability []
efficacy of therapy []

Secondary Outcome Measures

compare efficacy of this treatment to historical controls []

Eligibility Criteria

Criteria

Ages Eligible for Study:

51 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.
Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.
Patients with secondary myelodysplasia following cytotoxic chemotherapy. Exclusion Criteria:- Organ dysfunction