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A Phase II Trial of Cytarabine and Clofarabine in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Phase 2
16 Years
Open (Enrolling)

Thank you

Trial Information

A Phase II Trial of Cytarabine and Clofarabine in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Primary objective:

- Determine whether the complete remission rate in adult patients with relapsed or
refractory acute lymphoblastic leukemia (ALL) is sufficiently high after treatment with
cytarabine and clofarabine to warrant further investigation.

Secondary objectives:

- Estimate the frequency and severity of toxicities associated with this dosing schedule
of cytarabine and clofarabine.

- Investigate, preliminarily, the prognostic effects of cytogenetic features on response
to treatment in these patients.

Other objectives (if funding allows):

- Investigate, preliminarily, the prognostic effects of laboratory correlates (expression
of nucleoside transporters, expression of other pertinent genes by tissue microarray)
and FISH features on response to treatment in these patients

OUTLINE: This is an open-label, multicenter study.

- Induction therapy (1 or 2 courses): Patients receive induction therapy comprising
clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days
1-5 (course 1). Patients who achieve a response (5-25% blasts in the bone marrow with a
≥ 50% reduction in blasts from initial bone marrow aspirate) receive 1 more course of
induction therapy beginning no later than day 45. Patients who achieve complete
remission (< 5% blasts in the bone marrow) after 1 or 2 courses of induction therapy
may proceed to consolidation therapy.

- Consolidation therapy (1 course): Beginning within 60 days after the first day of the
last induction therapy, patients may receive consolidation therapy comprising
clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


- Prior morphologic diagnosis of acute lymphoblastic leukemia (ALL)

- No M0, mixed lineage, or L3 (Burkitt's) ALL

- Refractory to a standard induction regimen OR relapsed after successful prior
induction therapy

- Standard induction regimen is defined as any program of treatment that includes
vincristine and prednisone or high-dose cytarabine/mitoxantrone

- Any number of inductions or remissions allowed

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

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

- No extramedullary only disease in the absence of bone marrow or blood

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

- Patients with Philadelphia chromosome-positive (Ph+) ALL or bcr/abl-positive ALL who
were previously eligible for imatinib mesylate treatment must have received imatinib
mesylate either alone or in combination with chemotherapy for ALL and must have
either failed treatment or been unable to tolerate treatment

- No CNS involvement as determined by lumbar puncture (for previous CNS history or
clinical signs or symptoms of CNS) or by clinical exam (if no previous history or

- Must be registered on SWOG-S9910 and SWOG-9007


- Zubrod performance status 0-2

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 1.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- No psychiatric disorders that would interfere with study compliance

- No uncontrolled systemic fungal, bacterial, viral, or other infection

- No other severe concurrent disease

- No other serious or poorly controlled medical condition that would preclude study

- No history of serious organ dysfunction or disease involving the heart, kidney,
liver, or other organ system that would preclude study participation

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No pre-existing motor or sensory neuropathy ≥ grade 2

- No other prior malignancies, except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer in complete remission

- Any other prior cancer for which the patient has been disease free for ≥ 5 years


- See Disease Characteristics

- Recovered from prior therapy

- No prior clofarabine

- More than 2 weeks since prior chemotherapy, major surgery, or other investigational

- More than 6 weeks since prior monoclonal antibodies

- Prior allogeneic or autologous bone marrow transplant allowed provided the following
criteria are met:

- More than 90 days since transplant

- No acute graft-versus-host disease (GVHD) ≥ grade 2 OR moderate or severe
limited chronic GVHD OR extensive chronic GVHD of any severity

- Prior maintenance therapy with steroids, vincristine, and/or anti-metabolite agents,
such as, but not limited to, mercaptopurine, thioguanine, or methotrexate allowed

- Concurrent hydroxyurea allowed

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Complete Remission

Outcome Description:

Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extradmedullary disease

Outcome Time Frame:

Between day 28 and day 35 inclusive

Safety Issue:


Principal Investigator

Anjali Advani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

October 2006

Completion Date:

August 2013

Related Keywords:

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



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Houston Houston, Texas  77030
Wesley Medical Center Wichita, Kansas  67214
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Baylor University Medical Center - Houston Houston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Cleveland Clinic - Wooster Wooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
Stanford Cancer Center Stanford, California  94305-5824
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Clinton Memorial Hospital Wilmington, Ohio  45177
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Ben Taub General Hospital Houston, Texas  77030
Methodist Hospital Houston, Texas  77030
Providence Cancer Center Anchorage, Alaska  99508
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston, Texas  77030
Frontier Cancer Center Great Falls, Montana  59405