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LeukemiaPhase 2NCT00337168

S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

A Phase 2 study testing clofarabine and cytarabine in people with Leukemia, run by SWOG Cancer Research Network at 91 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: 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 more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Leukemia
What is being tested?
clofarabine and cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
91 sitesUnited States
Study dates
Oct 2006to Jan 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

91 sites in 1 country.

91 sites in 1 country

United States91 sites

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frontier Cancer Center

    Great Falls, Montana, 59405

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274-2600

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • 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 - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

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

RATIONALE: 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 more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving cytarabine together with clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Read the detailed description

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.

Conditions
Leukemia
Being tested
clofarabine, cytarabine
Keywords
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
Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clofarabineDrug

    Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4

  • cytarabineDrug

    Induction: 1g/m2/d; IV over 2 hrs; days 1-5 Re-induction (if necessary): 1g/m2/d; IV over 2 hrs; days 1-5 Consolidation: 1g/m2/d; IV over 2 hrs; days 1-4

Study groups in NCT00337168
Study groupRoleWhat they receive
Induc, ReInduc, Consol, clofarabine, cytarabineExperimentalInduction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4
Receives: Drug: clofarabine; Drug: cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Complete Remission

    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 extramedullary disease

    Measured: Between day 28 and day 35 inclusive

Secondary outcomes (3)

  1. Expression of Nucleoside Transporters

    Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.

    Measured: On average, two weeks before treatment started

  2. Number of Patients With Very Poor Risk Cytogenetics

    Measured: On average, 2 weeks before treatment started

  3. Toxicity

    Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

    Measured: Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionDec 2008
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00337168
Sponsor's protocol ID
S0530
Other IDs
U10CA032102, SWOG-S0530
Status last verified
Mar 2015
First submitted
13 Jun 2006
Last updated
25 Mar 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing clofarabine and cytarabine in people with Leukemia, run by SWOG Cancer Research Network at 91 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Complete Remission (time frame: Between day 28 and day 35 inclusive). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00337168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.

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