SWOG clinical trial number
S0910

A Phase II Study of Epratuzumab in Combination with Cytarabine and Clofarabine for Patients with Relapsed or Refractory Precursor B-cell Acute Lymphoblastic Leukemia

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Cytarabine/Clofarabine +/- Epratuzumab for Relapsed/Refractory B-cell ALL
Activated
08/15/2010
Closed
07/01/2012
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Leukemia

Treatment

Cytosine Arabinoside Clofarabine Epratuzumab

Eligibility Criteria Expand/Collapse

Pts must have refractory or relapsed Ph-negative precursor B cell ALL (any number of prior therapies) with evidence of ALL in marrow or blood. M0 AML, mixed lineage leukemia or Burkitts are not eligible. Pts must have >/= 5% lymphoblasts in blood or marrow and >/= 20% of lymphoblasts must be CD22+ by flow cytometry. Pretreatment cytogenetics must be performed. Pts must be offered participation in MRD testing. Pts must not have active CNS involvement. Pts with previous CNS or evidence of CNS must have lumbar puncture negative for CNS involvement. Pts may have received prior transplant, but must not be receiving immunosuppressive therapy for GvHD. Transplant must have been > 90 days prior to reg and pt must not have >/= Grade 2 GvHD. Pts must not have received chemo, other investigational agent or had major surgery within 14 days prior to reg (except hydroxyurea or maintenance with steroids, vincristine and/or anti-metabolite agents). Drug-related toxicities must have resolved to </= Grade 2. Pts must be >/= 16 yrs of age. Pts must not have received previous clofarabine or epratuzumab treatment. Pts must have Zubrod PS 0-2. Pts must have serum creatinine </= 2 OR estimated glomular filtration rate > 60 ml/min/1.73 m2. Pts must have SGOT and SGPT </= 2.5 x IULN, bilirubin </= 1.5 x IULN and alkaline phosphatase </= 2.5 x IULN. Pts must have triplicate EKG with corrected electrolytes. Study Coordinator must be contacted for QTc > 500 to determine eligibility. Pts must not have systemic, fungal, bacterial, viral or other uncontrolled infection. Pts must not have >/= Grade 2 neuropathy. HIV+ pts must be discussed with and approved by Study Coordinator. Pts must not be pregnant or nursing and must agree to use effective contraception. Prior malignancy other than ALL is allowed but must be in remission with no plan to treat at the time of reg. Pts must be informed of the investigational nature of the study and must sign and give written consent.

Publication Information Expand/Collapse

2018

Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood Jun 21;131(25):2782-2788; Apr 4 [Epub ahead of print]

PMid: PMID29618479 | PMC number: PMC6014358

2016

Comparable outcomes of patients eligible versus ineligible for SWOG leukemia studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood 128:4002; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

2014

SWOG S0910: A phase 2 trial of clofarabine/cytarabine/epratuzumab for relapsed/refractory acute lymphocytic leukemia

A Advani;S McDonough;S Coutre;B Wood;G Radich;M Mims;M O'Donnell;S Elkins;M Becker;M Othus;F Appelbaum British Journal of Haematology May;165(4):504-509;

PMid: PMID24579885 | PMC number: PMC4209396

2012

SWOG study S0910: a phase 2 trial of clofarabine/cytarabine/epratuzumab for relapsed/refractory acute lymphocytic leukemia

A Advani;S McDonough;SE Coutre;B Wood;J Radich;MP Mims;M O'Donnell;S Elkins;MW Becker;M Othus;F Appelbaum Blood 120(21):abst.2603; American Society of Hematology Annual Meeting, poster;