NCT00945815

S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

S0910, A Phase II Study of Epratuzumab (NSC-716711) in Combination With Cytarabine and Clofarabine for Patients With Relapsed or Refractory Ph- Negative Precursor B-Cell Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 16 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as epratuzumab, 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. Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Detailed description

OBJECTIVES: * To test whether the complete remission (CR) rate (CR and incomplete CR) in adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia is sufficiently high after treatment with cytarabine, clofarabine, and epratuzumab to warrant further investigation. * To estimate the frequency and severity of toxicities associated with the dosing schedule of cytarabine, clofarabine, and epratuzumab used in this study. * To investigate, preliminarily, the effect of laboratory correlates (minimal post-treatment residual disease) and cytogenetic factors on prognosis in this patient population. (Not reported here due to limited MRD data) OUTLINE: This is a multicenter study. Patients receive cytarabine IV over 2 hours on days 1-5, clofarabine IV over 1 hour on days 2-6, and epratuzumab IV over at least 1 hour on days 7, 14, 21, and 28 in the absence of disease progression or unacceptable toxicity\*. NOTE: \* Prophylactic intrathecal methotrexate is required for patients \< 22 years of age, and is recommended (but not required) for patients ≥ 22 years of age. Blood samples, bone marrow samples, and/or tumor tissue samples may be collected for further laboratory analysis. Patients are followed up every 3 months for 2 years, then annually for 3 years (until 5 years after registration).

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	epratuzumab
DRUG	clofarabine
DRUG	cytarabine
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-03-01
• Completion: 2017-08-01
• First posted: 2009-07-24
• Last updated: 2017-11-06
• Results posted: 2014-01-03

Locations

81 sites across 1 country: United States