Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Stopped early · Phase 2

Conditions studied: Recurrent Adult Acute Lymphoblastic Leukemia

In brief

This phase II trial is studying how well giving combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with alemtuzumab may kill more cancer cells.

Key facts

Study ID

NCT00262925

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2006-06-01

Expected to finish

2013-02-01

Last updated by the study team

2015-05-05

Who can join

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

You may qualify if…

• Refractory or relapsed acute lymphoblastic leukemia
• Must be in first relapse or have failed to achieve complete remission with 1 prior regimen
• Prior central nervous system (CNS) leukemia allowed provided cerebrospinal fluid is normal
• ECOG Performance status of 0-3
• Bilirubin normal
• Creatinine normal
• Human immunodeficiency virus (HIV) negative
• Negative pregnancy test
• Fertile patients must use effective contraception

You may not qualify if…

• Hepatitis B positivity
• Bacterial or fungal infection
• Infection requiring treatment with antibiotics
• Active cytomegalovirus infection by molecular detection methods
• Known hypersensitivity to alemtuzumab or its components
• Pregnant or nursing
• Other malignancy within the past 5 years except adequately treated basal cell skin cancer or cervical carcinoma

Where it is running

• Mercy Hospital and Medical Center — Chicago, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Edward H Kaplan MD and Associates — Skokie, Illinois, United States
• Carle Clinic-Urbana Main — Urbana, Illinois, United States
• Saint Anthony Memorial Health Center — Michigan City, Indiana, United States
• Siouxland Hematology Oncology Associates — Sioux City, Iowa, United States
• Mercy Medical Center-Sioux City — Sioux City, Iowa, United States
• Saint Luke's Regional Medical Center — Sioux City, Iowa, United States
• Cancer Center of Kansas - Chanute — Chanute, Kansas, United States
• Cancer Center of Kansas - Dodge City — Dodge City, Kansas, United States
• Cancer Center of Kansas - El Dorado — El Dorado, Kansas, United States
• Cancer Center of Kansas - Fort Scott — Fort Scott, Kansas, United States
• Cancer Center of Kansas-Independence — Independence, Kansas, United States
• Cancer Center of Kansas-Kingman — Kingman, Kansas, United States
• Lawrence Memorial Hospital — Lawrence, Kansas, United States
• Cancer Center of Kansas-Liberal — Liberal, Kansas, United States
• Cancer Center of Kansas - Newton — Newton, Kansas, United States
• Cancer Center of Kansas - Parsons — Parsons, Kansas, United States
• Cancer Center of Kansas - Pratt — Pratt, Kansas, United States
• Cancer Center of Kansas - Salina — Salina, Kansas, United States
• Cancer Center of Kansas - Wellington — Wellington, Kansas, United States
• Associates In Womens Health — Wichita, Kansas, United States
• Cancer Center of Kansas-Wichita Medical Arts Tower — Wichita, Kansas, United States
• Cancer Center of Kansas - Main Office — Wichita, Kansas, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States

Full record on ClinicalTrials.gov

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