Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

Completed · Not applicable

Conditions studied: Acute Myeloid Leukemia, Acute Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Multiple Myeloma, Lymphocytic Leukemia, Myeloproliferative Disorder, Polycythemia Vera, Myelofibrosis, Aplastic Anemia

In brief

New conditioning regimens are still needed to maximize efficacy and limit treatment-related deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.

Key facts

Study ID

NCT01499147

Run by

University of Illinois at Chicago

People needed

100

Starts

2000-02-01

Expected to finish

2013-05-01

Last updated by the study team

2018-11-08

Who can join

Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with the following diseases:
• Acute myeloid or lymphocytic leukemia in first remission at standard or high-risk for recurrence.
• Acute leukemia in greater than or equal to second remission, or with early relapse, or partial remission.
• Chronic myelogenous leukemia in accelerated phase or blast-crisis.
• Chronic myelogenous leukemia in chronic phase
• Recurrent or refractory malignant lymphoma or Hodgkin's disease
• Multiple myeloma.
• Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
• Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.
• Severe aplastic anemia after failure of immunosuppressive therapy.
• Age 10-65 years.
• Zubrod performance status less than or equal to 2.
• Adequate cardiac and pulmonary function. Patients with decreased LVEF < 40% or DLCO < 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
• Patient or guardian able to sign informed consent.

You may not qualify if…

• Life expectancy is severely limited by concomitant illness.
• Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min .
• Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit of normal
• Evidence of chronic active hepatitis or cirrhosis
• HIV-positive
• Patient is pregnant

Where it is running

• University of Illinois at Chicago Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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