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LeukemiaPhase 2NCT00003671

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

A Phase 2 study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by Children's Oncology Group at 57 sites in 5 countries.

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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Leukemia
What is being tested?
asparaginase, cyclophosphamide and cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
57 sitesin 5 countries
Study dates
Dec 1998to Feb 2009
Phase
Phase 2
Are there results?
None posted in the registry

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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS: Histologically newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for induction therapy Average prognosis (neither very good nor very poor)

PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400

Trial locations and contacts

57 sites in 5 countries.

57 sites in 5 countries

United States50 sites

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87131

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • West Virginia University Medical School, Charleston Division

    Charleston, West Virginia, 25304

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri, 65212

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • St. John's Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22046

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • University of Texas Medical Branch

    Galveston, Texas, 77555-1329

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • James H. Quillen College of Medicine

    Johnson City, Tennessee, 37614-0622

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9162

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Christ Hospital

    Oak Lawn, Illinois, 60453

  • Oklahoma Memorial Hospital

    Oklahoma City, Oklahoma, 73126-0307

  • Walt Disney Memorial Cancer Institute

    Orlando, Florida, 32803

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61602

  • Maine Children's Cancer Program

    Portland, Maine, 04101

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24029

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California, 92120

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-9832

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Scott and White Clinic

    Temple, Texas, 76508

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • Via Christi Regional Medical Center-Saint Francis Campus

    Wichita, Kansas, 67214

Other trials in United States

Canada4 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Centre Hospitalier de L'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

Other trials in Canada

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

Other trials in Netherlands

Puerto Rico1 site

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

Switzerland1 site

  • Clinique de Pediatrie

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.

Read the detailed description

OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in children with average risk acute lymphocytic leukemia. II. Determine the feasibility of delivering 6 courses of this therapy in these patients.

OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion, methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24 until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks 8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29, daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21, and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48 hours after the start of oral methotrexate. Patients also receive methotrexate IT during week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another continuation: Patients receive oral methotrexate once weekly except during the week of methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment continues for up to 130 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually for ten years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.

Conditions
Leukemia
Being tested
asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone
Keywords
untreated childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia
Medical subject headings
Leukemia

What participants receive

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

  • asparaginaseDrug

    Also called E. coli, Elspar, NSC #109229

  • cyclophosphamideDrug

    Also called CTX, Cytoxan, NSC #026271, IND #7089

  • cytarabineDrug

    Also called cytosine arabinoside, Ara-C, Cytosar, NSC #063878

  • daunorubicin hydrochlorideDrug

    Also called daunomycin, DNR, Cerubidine, NSC #82151

  • dexamethasoneDrug

    Also called Decadron, NSC #034521

  • leucovorin calciumDrug

    Also called LCV, Wellcovorin, citrovorum factor, folinic acid

  • mercaptopurineDrug

    Also called 6-MP, Purinethol, NSC #000755

  • methotrexateDrug

    Also called MTX, amethopterin, NSC #000740, IND #4291

  • thioguanineDrug

    Also called 6-thioguanine, 6-TG, NSC #752

  • vincristine sulfateDrug

    Also called VCR, Oncovin, NSC #067574, IND #7161

Study groups in NCT00003671
Study groupRoleWhat they receive
Chemotherapy TreatmentExperimentalSee detailed description.
Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: thioguanine; Drug: vincristine sulfate

What is being measured

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

  1. Event-free survival

    Measured: 7 years

Timeline

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

  1. First posted13 Sep 2004 (estimated)
  2. Study startDec 1998
  3. Primary completionNov 2002
  4. Study completionFeb 2009

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
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003671
Sponsor's protocol ID
9705
Other IDs
POG-9705, CDR0000066768
Status last verified
Jul 2014
First submitted
1 Nov 1999
Last updated
25 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by Children's Oncology Group at 57 sites in 5 countries.

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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Canada, Netherlands, Puerto Rico, Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Event-free survival (time frame: 7 years). 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 NCT00003671.

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 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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