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



Status:Completed
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:16 - 120
Updated:11/8/2017
Start Date:September 2010
End Date:August 2017

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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

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.

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).

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)
We found this trial at
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1504 Taub Loop
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2720 Clare Avenue
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
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200 Hawthorne Lane
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2010 E 90th St
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1500 E Duarte Rd
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900 West Faris Road
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3 Butternut Drive, Suite B
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33 Villa Road, Suite 400
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340 Medical Pkwy
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2500 N. State St.
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1415 E. Kincaid
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19500 10th Ave NE # 100
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601 Elmwood Avenue
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2279 45th Street
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601 South Sherman Street
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1101 N 27th St # 201
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2900 12th Ave N Ste 160W
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16233 Sylvester Rd SW #110
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1303 North Main Street
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1 Wyoming St
Dayton, Ohio 45409
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Dayton, Ohio 45406
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105 Mcknight Drive
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1101 26th Street South
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2475 Broadway St
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One Baylor Plaza
Houston, Texas 77030
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Issaquah, Washington 98029
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310 Sunnyview Ln
Kalispell, Montana 59901
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75 Claremont St Ste E
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Little Rock, Arkansas 72205
(501) 296-1200
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500 E 1400 N
Logan, Utah 84341
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1100 Reid Pkwy
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