Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome.

Primary Objective:

1. To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation.

Secondary Objectives:

1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy.

2. To evaluate the incidence and severity of GVHD in this population

3. To evaluate disease-free and overall survival and relapse rates.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Antilymphocyte Serum; Fludarabine; Fludarabine phosphate; Gemtuzumab; Melphalan; Thymoglobulin; Vidarabine

Criteria

Inclusion Criteria:

• Patients 12-75 years of age

• Patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. Patients with refractory AML are always eligible if ejection fraction > 35, FEV1, FVC, or DLCO > 40%, abnormal LFT's.

• Patients must have recovered from previous Grade III-IV toxicity due to prior anti-neoplastic therapy (except alopecia).

• Patients with the following disease categories will be eligible:

1. AML with induction failure, relapse or 2nd remission

2. MDS with IPI INT-2 or High-risk disease (Appendix 4) or CMML

3. CML in accelerated phase or blast crisis

4. Interferon or STI resistant CML not eligible for conventional stem cell transplant

• Patients receiving prior BMT are eligible. If myeloablative chemoradiotherapy was used in the prior transplant patients must be >90 days from transplant. If non-myeloablative therapy was used patients must be >30 days post-transplant.

• Leukemia cells must express cell surface CD33 evaluated by flow cytometry in > 20% of leukemia cells.

• Patients must have an HLA-compatible related donor (6/6 or 5/6 HLA-match) capable of donating bone marrow or G-CSF stimulated peripheral blood stem cells using aphereses techniques or a 6/6 HLA matched unrelated bone marrow donor (serologic matching for Class I, molecular matching for DR?1).

• Patients must have a ECOG PS<2 (Appendix 6), Cr<2.0, bilirubin <2, and (SGPT) <3x normal

• Patients must have an estimated life expectancy > 3 months

• Patient and donor must sign informed consent. Unrelated donors will be consented according to the National Donor Marrow Registry policy

Exclusion Criteria:

• uncontrolled active infection

• HIV disease

• pregnancy and nursing

• active, uncontrolled CNS leukemia