Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

Stanford University

Status: Completed

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

Treatments: Procedure: ablative allogeneic hematopoietic cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00186342

BMT45

NCT00186342

75274

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 51 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

CIK cell

Experimental group

Description:

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.

Treatment:

Procedure: ablative allogeneic hematopoietic cell transplantation