Evaluation of the Anti-CD-33 Immunotoxin Hum-195/rGel in Patients With Advanced Myeloid Malignancies

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myeloproliferative Disorders, Anemia, Refractory, With Excess of Blasts

In brief

The goal of this clinical research study is to find the highest safe dose of the anti-CD33 immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies. This treatment will be given to patients whose leukemia has not responded to prior chemotherapy.

Key facts

Study ID

NCT00038051

Run by

M.D. Anderson Cancer Center

People needed

28

Starts

1999-05-01

Expected to finish

2013-02-01

Last updated by the study team

2013-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with relapsed or refractory acute myelogenous leukemia (AML), Refractory anemia with excess blasts in transformation (RAEB-t), Refractory Anemia with Excess Blasts (RAEB), or chronic myelomonocytic leukaemia (CMML) who failed at least one previous chemotherapy course. Patients with accelerated CML Ph+ or myeloid blastic crisis are eligible. Patients in accelerated phase of non-Philadelphia chromosome + myeloproliferative disorders are also eligible:
• P. vera,
• myelofibrosis
• essential thrombocytopenia with >5% blasts in the blood or bone marrow.
• Male or female 18 yrs of age or older who have provided written informed consent
• Tumor cells must be = or > 80% CD33 positive by flow cytometry
• For women of childbearing potential (i.e. exclude post-menopausal women, women who have been surgically sterilized), adequate birth control methods must be used. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with a condom
• White blood count (WBC) count <10,000/ml for AML, MDS, and myeloproliferative disorders and up to 30,000 for accelerated CML
• No cytotoxic chemotherapy for the two weeks prior to entering the study
• No evidence of residual toxic effects grade 2 or higher from prior chemotherapy
• Patients with proven bacterial infection are not eligible until resolution of the infection (patient afebrile, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and they do not have fever exceeding 38°C
• Creatinine - Patients should have values = or < 1.5 times the upper limit of laboratory normal values
• Liver function - Patients should have serum bilirubin values = or < 2.0 times the upper limit of laboratory normal values. Patients should have SGOT and/or SGPT levels = or < 2.5 times the upper limit of laboratory normal values
• Cardiac function - Patients with cardiovascular disease should be < New York Heart Association (NYHA) classification III
• Pulmonary function - O2 saturation should be = or > 92% without exogenous O2 administered.
• Neurologic function - Patients should have normal central nervous system function as well as normal motor function consistent with = or < Grade 1 toxicity. Patients should have peripheral sensory function damage (neuropathy) not exceeding Grade 1 toxicity

You may not qualify if…

• Women who are pregnant or lactating

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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