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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
N/A
Open (Enrolling)
Both
Leukemia

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
1-4.

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


DISEASE CHARACTERISTICS:

- 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
involvement

- 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
signs/symptoms)

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

PATIENT CHARACTERISTICS:

- 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
participation

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- No prior clofarabine

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

- 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:

Interventional

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:

No

Principal Investigator

Anjali Advani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000481340

NCT ID:

NCT00337168

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

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
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Wesley Medical CenterWichita, Kansas  67214
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
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
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
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
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
Community Medical CenterMissoula, Montana  59801
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
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
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Minor and James Medical, PLLCSeattle, Washington  98104
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
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Clinton Memorial HospitalWilmington, Ohio  45177
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Ben Taub General HospitalHouston, Texas  77030
Methodist HospitalHouston, Texas  77030
Providence Cancer CenterAnchorage, Alaska  99508
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
St. Luke's Texas Cancer Institute at St. Luke's Episcopal HospitalHouston, Texas  77030
Frontier Cancer CenterGreat Falls, Montana  59405