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LeukemiaPhase 2NCT00109837

S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Leukemia, run by SWOG Cancer Research Network at 78 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy 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), and giving the drugs in different combinations may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Leukemia
What is being tested?
filgrastim, cyclophosphamide and cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
78 sitesUnited States
Study dates
Apr 2005to Nov 2014
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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Morphologically confirmed acute lymphoblastic leukemia (ALL), meeting any of the following criteria:
  • FAB class L1 or L2 disease
  • Mixed lineage ALL
  • Ph-negative/BCR/ABL-negative
  • Newly diagnosed disease
  • Patients with the following diagnoses are not eligible:
  • FAB class L3 ALL
  • Non-Hodgkin's lymphoma
  • Chronic myelogenous leukemia in lymphoid blast crisis
  • Mixed lineage acute myeloid leukemia
  • Acute minimally differentiated myeloid leukemia (M0)
  • Must be registered on protocols SWOG-9007 AND SWOG-S9910

PATIENT CHARACTERISTICS:

Age

  • 18 to 64

Performance status

  • Zubrod 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No chronic liver disease
  • Hepatitis panel, including hepatitis B and C, negative
  • History of hepatitis A with positive antibody allowed

Renal

  • Creatinine ≤ 1.5 times upper limit of normal OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • Left ventricular function normal
  • Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram
  • No symptomatic congestive heart failure
  • No coronary artery disease
  • No cardiomyopathy
  • No uncontrolled arrhythmia

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior remission induction chemotherapy for ALL
  • Prior hydroxyurea to control WBC count allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other prior treatment for ALL

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

United States78 sites

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • 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

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • 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

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Frontier Cancer Center

    Great Falls, Montana, 59405

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Northern Montana Hospital

    Havre, Montana, 59501

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Independence Regional Health Center

    Independence, Missouri, 64050

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Liberty Hospital

    Liberty, Missouri, 64068

  • 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

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • 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

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • 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

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

Official title: A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy

RATIONALE: Drugs used in chemotherapy 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), and giving the drugs in different combinations may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the probability of 1-year continuous complete remission in patients with newly diagnosed acute lymphoblastic leukemia treated with first induction chemotherapy comprising daunorubicin, vincristine, prednisone, and pegaspargase; and second induction chemotherapy comprising high-dose cytarabine and mitoxantrone.

Secondary

  • Determine the frequency and severity of toxic effects of these induction regimens followed by consolidation therapy comprising cyclophosphamide, cytarabine, mercaptopurine, and methotrexate and maintenance chemotherapy comprising mercaptopurine, methotrexate, vincristine, doxorubicin, dexamethasone, cyclophosphamide, thioguanine, and cytarabine in these patients.

Other objectives (if funding allows):

  • To evaluate in a preliminary manner the significance of detecting minimal residual disease as a prognostic factor for survival and relapse-free survival of patients receiving chemotherapy
  • To evaluate in a preliminary manner the pattern of gene expression of patients entered onto the trial and its relationship to cytogenetics/FISH risk classification, overall survival, and relapse-free survival

OUTLINE: This is a multicenter study.

  • First induction chemotherapy: Patients receive daunorubicin IV on days 1-3; vincristine IV on days 1, 8, 15, and 22; prednisone IV or orally on days 1-28, followed by a taper to day 35; and pegaspargase IV or subcutaneously (SC) on day 15. Patients with CNS leukemia also receive methotrexate intrathecally (IT) or intraventricularly twice weekly and oral leucovorin calcium four times daily for 4 doses after each administration of methotrexate. When blasts are no longer present in the spinal fluid, patients receive methotrexate IT or intraventricularly once weekly for 4 weeks and then once monthly for 1 year.

Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1 peripheral blood status or those with resistant disease proceed to second induction therapy.

  • Second induction chemotherapy: Patients receive high-dose cytarabine IV on days 1-5; mitoxantrone IV on day 3; and filgrastim (G-CSF) SC or IV beginning on day 7 and continuing until blood counts recover. Patients with CNS leukemia also receive methotrexate and leucovorin calcium as in first induction chemotherapy.

Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1 peripheral blood status with no extramedullary disease (other than CNS involvement) proceed to consolidation chemotherapy. Patients with resistant disease OR Philadelphia chromosome- or BCR/ABL-positive disease are removed from the study after receiving double induction chemotherapy.

  • Consolidation chemotherapy: Patients receive cyclophosphamide IV on days 1, 15, and 29; cytarabine IV on days 2-5 and 16-19; oral mercaptopurine on days 1-28; and methotrexate IT or intraventricularly on days 2, 9, 16, and 23. Patients with CNS leukemia also undergo cranial radiotherapy once daily, 5 days a week, for 2 weeks.

Patients in complete remission proceed to maintenance chemotherapy.

  • Maintenance chemotherapy:
  • Course 1: Patients receive oral mercaptopurine on days 1-63 and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients proceed to course 2 after blood counts recover.
  • Course 2: Patients receive vincristine IV and doxorubicin IV on days 1, 8, 15, and 22 and oral dexamethasone on days 1-28. Patients proceed to course 3 after blood counts recover.
  • Course 3: Patients receive cyclophosphamide IV on day 1; oral thioguanine on days 1-14; and cytarabine IV on days 3-6 and 10-13. Patients proceed to course 4 after blood counts recover.
  • Course 4: Patients receive oral mercaptopurine once daily for 2 years and oral methotrexate once weekly for 2 years.

Treatment continues in the absence of disease relapse or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Conditions
Leukemia
Keywords
L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, untreated 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.

  • filgrastimBiological

    As needed per physician discretion

  • cyclophosphamideDrug

    Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1

  • cytarabineDrug

    Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13

  • daunorubicinDrug

    Induction: 60 mg/m2/d; IV; days 1, 2, and 3

  • dexamethasoneDrug

    Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28

  • doxorubicinDrug

    Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22

  • leucovorinDrug

    For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC < 3,000

  • mercaptopurineDrug

    Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs

  • methotrexateDrug

    Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs

  • mitoxantroneDrug

    Induction 2: 80 mg/m2; IV; day 3

  • AsparaginaseDrug

    Induction: 2,000 IU/m2; IM or IV; day 15

  • prednisoneDrug

    Induction: 60 mg/m2/d; PO or IV; days 1-35

  • thioguanineDrug

    Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14

  • vincristineDrug

    Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22

  • radiation therapyRadiation

    For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.

  • allopurinolDrug

    300 mg/d PO Days 1-7

  • bactrimDrug

    1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone

Study groups in NCT00109837
Study groupRoleWhat they receive
Induc x2, Consol, MaintExperimentalInduc 1: Allopurinol; Daunorubicin; Vincristine; Prednisone; asparaginase; Bactrim Induc 2: Allopurinol; cytarabine; Dexamethasone; filgrastim; mitoxantrone; Methotrexate; leucovorin Consol: Cyclophosphamide; cytarabine; 6-mercaptopurine; Methotrexate; filgrastim Maint:Course 1: 6-mercaptopurine; Methotrexate Course 2: Vincristine; doxorubicin; Dexamethasone Course 3: Cyclophosphamidee; thioguanine; cytarabine Course 4: 6-mercaptopurine; methotrexate
Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin; Drug: dexamethasone; Drug: doxorubicin; Drug: leucovorin; Drug: mercaptopurine; Drug: methotrexate; Drug: mitoxantrone; Drug: Asparaginase; Drug: prednisone; Drug: thioguanine; Drug: vincristine; Radiation: radiation therapy; Drug: allopurinol; Drug: bactrim

What is being measured

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

  1. Continuous Complete Remission at 1 Year

    A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.

    Measured: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year

Secondary outcomes (1)

  1. 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 assessed for adverse events after the induction cycle

Timeline

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

  1. First posted4 May 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionNov 2010
  4. Study completionNov 2014

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
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109837
Sponsor's protocol ID
S0333
Other IDs
U10CA032102, S0333
Status last verified
Mar 2015
First submitted
3 May 2005
Last updated
25 Mar 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Leukemia, run by SWOG Cancer Research Network at 78 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 78 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 23 Aug 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?

Continuous Complete Remission at 1 Year (time frame: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year). 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 NCT00109837.

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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