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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


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

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


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, expression of nucleoside transporters, and expression
of other pertinent genes by tissue microarray) and cytogenetic factors on prognosis in
this patient population.

- To investigate, preliminarily, whether the expression of specific genes, such as OPAL-1
(outcome predictor in acute leukemia 1), RANTES, and connective tissue growth factor,
associated with poor outcome in retrospective studies, correlates with outcome in this
study.(Closed as of 07/01/2010)

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.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then annually for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Morphologically confirmed precursor B-cell acute lymphoblastic leukemia (ALL) (non
T-cell)

- Must have evidence of disease in bone marrow or peripheral blood

- Immunophenotyping of the blood or marrow lymphoblasts must be performed to
determine lineage (B cell, T cell, or mixed B/T cell)

- Must have ≥ 5% lymphoblasts present in the blood or bone marrow

- At least 20% of marrow and/or peripheral blood lymphoblasts must be CD22+
by flow cytometry

- Co-expression of myeloid antigens (CD13 and CD33) allowed

- Patients with only extramedullary disease in the absence of bone marrow or
blood involvement are not eligible

- Philadelphia (Ph) chromosome-negative disease

- Patients with unknown Ph status by cytogenetics or FISH and unknown BCR/ABL
status by PCR are eligible for study registration, but must be removed from
study therapy if found to be Ph+ or BCR/ABL+ after study registration

- Refractory to a standard induction regimen that included vincristine and prednisone
or high-dose cytarabine or mitoxantrone OR relapsed after successful prior induction
therapy

- Any number of prior induction therapies or any number of remissions achieved are
allowed

- No M0 acute myeloid leukemia, mixed lineage leukemia, or L3 (Burkitt) leukemia

- No active CNS involvement by clinical evaluation

- Patients with a documented history of CNS involvement of ALL or with clinical
signs or symptoms consistent with CNS involvement of ALL must undergo a lumbar
puncture that is negative for CNS involvement of ALL

- Patients < 22 years of age must be willing to receive prophylactic intrathecal
chemotherapy

- Must be registered on SWOG-9007 "Cytogenetic Studies in Leukemia Patients" (closed as
of 07/01/2010)

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- HIV-positive patients are eligible (at the discretion of the investigator) provided
the following criteria are met:

- No history of AIDS-defining conditions

- CD4 cell count > 350/mm³

- If on antiretroviral agents, must not include zidovudine or stavudine

- Willing to receive prophylaxis for pneumocystis jirovecii pneumonia during study
therapy (regardless of CD4 cell count) until the CD4 cell count is > 200/mm³
after completion of study treatment

- Prior malignancy (other than ALL) allowed provided it is in remission and there are
no plans to treat the malignancy at the time of study registration

- No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as
exhibiting ongoing signs or symptoms related to the infection with no improvement
despite appropriate antibiotics or other treatment

- No neuropathy (cranial, motor or sensory) ≥ grade 2

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Any number of prior therapies allowed

- More than 90 days since prior allogeneic bone marrow transplant (BMT)

- No concurrent immunosuppression therapy for the treatment of graft-vs-host
disease (GVHD)

- No acute GVHD ≥ grade 2, moderate or severe limited chronic GVHD, or extensive
chronic GVHD of any severity

- Prior autologous BMT allowed

- No concurrent immunosuppression therapy for the treatment of GVHD

- More than 14 days since prior chemotherapy, investigational agents, or major surgery
and recovered

- Maintenance therapy with steroids, vincristine, and/or anti-metabolite agents,
including but not limited to, mercaptopurine, thioguanine, and methotrexate
allowed

- Concurrent hydroxyurea to reduce WBC to a reasonable level (as deemed by the
treating physician) allowed

- No prior clofarabine or epratuzumab

- No other concurrent cytotoxic therapy or investigational therapy

- No concurrent alternative medications (e.g., herbal or botanical medications for
anticancer purposes)

- Concurrent participation on SWOG-S9910 "Leukemia Centralized Reference Laboratories
and Tissue Repositories, Ancillary" allowed (closed as of 07/01/2010)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR) rate (CR and incomplete CR)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Anjali Advani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000649725

NCT ID:

NCT00945815

Start Date:

September 2010

Completion Date:

July 2017

Related Keywords:

  • Leukemia
  • B-cell adult acute lymphoblastic leukemia
  • L1 adult acute lymphoblastic leukemia
  • L2 adult acute lymphoblastic leukemia
  • recurrent adult acute lymphoblastic leukemia
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
LDS HospitalSalt Lake City, Utah  84143
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Stanford Cancer CenterStanford, California  94305-5824
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Wayne HospitalGreenville, Ohio  45331
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Ben Taub General HospitalHouston, Texas  77030
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Hematology-Oncology ClinicBaton Rouge, Louisiana  70808
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
St. Luke's Texas Cancer Institute at St. Luke's Episcopal HospitalHouston, Texas  77030
Island Hospital Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center Cancer CenterBurien, Washington  98166
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029