TLI & ATG for Non-Myeloablative Allogeneic Transplantation for MDS and MPD

Completed · Phase 2

Conditions studied: Myeloproliferative Disorders, Blood Cancer, Myelodysplastic Syndromes

In brief

To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly patients with advanced stage MDS and MPD.

Key facts

Study ID

NCT00185796

Run by

Stanford University

People needed

77

Starts

2004-07-01

Expected to finish

2015-02-01

Last updated by the study team

2015-03-18

Who can join

Age: 49 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• GENERAL INCLUSION CRITERIA
• General inclusion criteria must include at least one of the following:
• Patients aged > 49 and < 75 years with MDS or MPD
• Patients aged < 49 years at high risk for regimen related toxicity using standard high dose regimens. Factors considered high risk include pre-existing conditions such as a chronic disease affecting kidneys, liver, lungs, or heart.
• Patients with secondary MDS following a prior autologous transplant.
• An HLA-identical related or an HLA-matched unrelated donor is available. ABO incompatibility is acceptable.
• A signed informed consent form.
• MYELODYSPLASTIC SYNDROME CRITERIA
• Diagnosis of MDS classifiable by the FAB system as refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), chronic myelomonocytic leukemia (CMML), refractory anemia with excess blasts (RAEB), and MDS transformed to acute leukemia.
• Patients with advanced MDS must be cytoreduced to < 10% marrow blasts prior to receiving conditioning with TLI/ATG. Less than 10% marrow blasts must be documented by marrow examination within 1 month of starting conditioning. The cytoreductive regimen will be determined by referring centers.
• Patients with evolution to AML are required to be in a complete remission as defined by a blast count of less than 5% in a marrow aspirate with adequate cellularity. Presence of residual dysplastic features following cytoreductive therapy is acceptable.
• All patients with high risk disease, for example "intermediate-2" or "high risk" disease by the IPSS score. Other selected patients with a lower IPSS score may be considered but only after discussion with the BMT attending physicians, as a group, and the PI of the study.
• MYELOPROLIFERATIVE DISORDERS
• Myeloproliferative disorders to be included:
• Philadelphia chromosome-negative CML.
• Patients with polycythemia vera with persistent thrombotic or hemorrhagic complications despite conventional therapy, or who have progressed to post-polycythemic marrow fibrosis.
• Patients with essential thrombocythemia with persistent thrombotic or hemorrhagic complications despite conventional therapy, or who have progressed to myelofibrosis.
• Patients with agnogenic myeloid metaplasia with high risk disease, for example "intermediate" or "high risk" according to the Lille Scoring System.
• Patients must be cytoreduced to < 10% marrow blasts. Less than 10% marrow blasts must be documented by marrow examination within 1 month of initiation of TLI/ATG. The cytoreductive regimen will be determined by referring centers.
• Patients with evolution to AML are required to be in a complete remission as defined by a blast count of less than 5% in a marrow aspirate with adequate cellularity. Presence of residual dysplastic features following cytoreductive therapy is acceptable.
• INCLUSION CRITERIA - RELATED DONORS
• Related to the patient and is genotypically or phenotypically HLA-identical.
• Donor age < 75 unless cleared by P.I
• Capable of giving written, informed consent.
• Donor must consent to PBSC mobilization with G-CSF and apheresis

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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