LeukemiaNCT00343369
Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia
A study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by Universitätsklinikum Hamburg-Eppendorf at 16 sites in Germany.
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) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Leukemia
- What is being tested?
- asparaginase, cyclophosphamide and cytarabine
- Type of treatment
- Surgery or procedure
- How many people
- 550 participants
- Where
- 16 sitesGermany
- Study dates
- Jan 2003to not given
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Diagnosed with acute B-precursor or T-cell acute lymphoblastic leukemia (ALL)
- Meets 1 of the following risk criteria:
- Low-risk disease, defined by any of the following:
- WBC < 25/nL
- B-precursor ALL
- Excluding pro-B ALL
- High-risk disease, defined by any of the following:
- WBC ≥ 25/nL
- T-cell ALL or pro-B ALL
- Chromosomal translocation 4/11
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- More than 7 days since prior therapy with steroids, vincristine, or daunorubicin hydrochloride
- More than 7 days since prior cytotoxic therapy
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites, 16 recruiting
- Recruiting
Evangelisches Krankenhauus Bielfeld
Biefeld, 33617
N. Jorch, MD, 49-52-177-278-050
- Recruiting
Klinikum Bremen-Mitte
Bremen, D-28205
Arnulf Pekrun, MD, PhD, 49-421-497-3656, arnulf.pekrun@klinikum-bremen-mitte.de
- Recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf, D-40225
Contact Person, 49-211-311-7990
- Recruiting
Universitats - Kinderklinik
Greiswald, 17487
James F. Beck, MD, 49-383-486-6325, beck@uni-greifswald.de
- Recruiting
University Medical Center Hamburg - Eppendorf
Hamburg, D-20246
Gritta Janka-Schaub, 49-404-2803-2580
- Recruiting
Kreskrankenhaus Kinderabteilung
Heide, 25746
Streitberger, 49-481-785-911
- Recruiting
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, D-55743
Wenzel Nuernberger, MD, PhD, 49-6781-66-1582, wnuernberger@bmt-center-io.com
- Recruiting
Klinikum Krefeld GmbH
Krefeld, D-47805
P. Thomas, 49-2151-322-375
- Recruiting
Universitaets - Kinderklinik
Leipzig, D-04317
Dieter Koerholz, MD, 49-341-9726-246, koerd@medizin.uni-leipzig.de
- Recruiting
Johannes Gutenberg University
Mainz, D-55101
P. Gutjahr, MD, 49-6131-17-2112
- Recruiting
Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin
Mönchengladbach, D-41066
Wolfgang Mueller, MD, 49-2161-668-2481
- Recruiting
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, D-80337
Arndt Borkhardt, 49-89-5160-4498
- Recruiting
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, D-81545
Papucek, 49-89-6210-2710
- Recruiting
Klinik St. Hedwig-Kinderklinik
Regensburg, 93049
Ove Peters, 49-941-369-5404
- Recruiting
Dr. Horst-Schmidt-Kliniken
Wiesbaden, D-65199
Gerhard Beron, MD, 49-611-43-2564
- Recruiting
Helios Kliniken Wuppertal University Hospital
Wuppertal, D-42283
B. Dohrn, MD, 49-202-896-3823, bdohrn@wuppertal.helios-klinikum.de
About this study
Official title: Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia
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) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- Determine the dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride in pediatric patients with acute lymphoblastic leukemia (ALL).
- Determine whether it is possible to reduce therapy in pediatric patients with low-risk ALL and a PVA (prednisolone-vincristine-asparaginase) score of 3+4 without loss of efficacy.
- Investigate the role of single nucleotide polymorphisms of infection defense gene for infectious complications during therapy in these patients.
- Reduce neurological complications by reducing doses of intrathecal methotrexate.
- Reduce allergic reactions against asparaginase (ASP) by using pegaspargase after E. coli ASP.
OUTLINE: This is a randomized, multicenter study.
- Prephase: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive doxorubicin hydrochloride IV once.
- Arm II: Patients receive daunorubicin hydrochloride IV once.
- Arm III: Patients receive daunorubicin hydrochloride IV once at a higher dose than in arm II.
- Induction phase: All patients receive vincristine IV 4 times weekly, daunorubicin hydrochloride IV 3 times weekly, and oral prednisolone daily for 4 weeks.
- Intensive phase: Patients are stratified according to risk (low vs high).
- Low-risk disease*: Patients receive 4 courses of methotrexate IV and asparaginase intramuscularly (IM).
- High-risk disease*: Patients receive 6 courses of cyclophosphamide IV, methotrexate IV, and asparaginase IM.
All patients also receive methotrexate IV, teniposide IV, cytarabine IV, high-dose cytarabine IV, and asparaginase IM after completion of the above regimen.
- CNS phase: All patients receive intrathecal (IT) methotrexate for 3 doses and oral mercaptopurine for 4 weeks. Patients with T-cell acute lymphoblastic leukemia or patients who have blasts in cerebrospinal fluid at diagnosis or whose WBC > 200/nL at diagnosis OR whose WBC between 100-200/nL at diagnosis and blasts > 1/nL after prephase chemotherapy undergo cranial irradiation.
- Reinduction phase: Patients are stratified according to risk (low vs high)
- Low-risk disease*: Patients receive 2 courses of doxorubicin hydrochloride IV, vincristine IV, and oral dexamethasone; pegaspargase IM once; and 1 course of cyclophosphamide IV, cytarabine IV, and oral thioguanine.
- High-risk disease*: Patients receive 4 courses of doxorubicin hydrochloride IV, vincristine IV, and oral dexamethasone; pegaspargase IM twice; and 2 courses of cyclophosphamide IV, cytarabine IV, and oral thioguanine.
- Maintenance phase: All patients receive oral mercaptopurine daily and methotrexate IV once weekly for up to 2 years after diagnosis.
NOTE: *In addition to those defined in Disease Characteristics, patients who do not achieve remission after induction phase are treated as high-risk disease, patients who achieve remission after induction phase are treated as low-risk disease
PROJECTED ACCRUAL: A total of 550 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone
- Keywords
- B-cell childhood acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, untreated childhood 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.
asparaginaseDrug
cyclophosphamideDrug
cytarabineDrug
daunorubicin hydrochlorideDrug
dexamethasoneDrug
mercaptopurineDrug
methotrexateDrug
pegaspargaseDrug
prednisoloneDrug
teniposideDrug
thioguanineDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride
Reduce therapy in low-risk patients without loss of efficacy
Reduce neurological complications
Reduce allergic reactions against asparaginase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Investigators
- Gritta Janka-Schaub, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343369
- Sponsor's protocol ID
- CDR0000455738
- Other IDs
- GER-COALL-07-03, EU-205104
- Status last verified
- Jun 2006
- First submitted
- 22 Jun 2006
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00343369
- Acronym / sponsor ID
- CDR0000455738
- Conditions
- Leukemia
- Keywords
- B-cell childhood acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 23 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- Determine the dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride in pediatric patients with acute lymphoblastic leukemia (ALL).
- Determine whether it is possible to reduce therapy in pediatric patients with low-risk ALL and a PVA (prednisolone-vincristine-asparaginase) score of 3+4 without loss of efficacy.
- Investigate the role of single nucleotide polymorphisms of infection defense gene for infectious complications during therapy in these patients.
- Reduce neurological complications by reducing doses of intrathecal methotrexate.
- Reduce allergic reactions against asparaginase (ASP) by using pegaspargase after E. coli ASP.
OUTLINE: This is a randomized, multicenter study.
- Prephase: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive doxorubicin hydrochloride IV once.
- Arm II: Patients receive daunorubicin hydrochloride IV once.
- Arm III: Patients receive daunorubicin hydrochloride IV once at a higher dose than in arm II.
- Induction phase: All patients receive vincristine IV 4 times weekly, daunorubicin hydrochloride IV 3 times weekly, and oral prednisolone daily for 4 weeks.
- Intensive phase: Patients are stratified according to risk (low vs high).
- Low-risk disease*: Patients receive 4 courses of methotrexate IV and asparaginase intramuscularly (IM).
- High-risk disease*: Patients receive 6 courses of cyclophosphamide IV, methotrexate IV, and asparaginase IM.
All patients also receive methotrexate IV, teniposide IV, cytarabine IV, high-dose cytarabine IV, and asparaginase IM after completion of the above regimen.
- CNS phase: All patients receive intrathecal (IT) methotrexate for 3 doses and oral mercaptopurine for 4 weeks. Patients with T-cell acute lymphoblastic leukemia or patients who have blasts in cerebrospinal fluid at diagnosis or whose WBC > 200/nL at diagnosis OR whose WBC between 100-200/nL at diagnosis and blasts > 1/nL after prephase chemotherapy undergo cranial irradiation.
- Reinduction phase: Patients are stratified according to risk (low vs high)
- Low-risk disease*: Patients receive 2 courses of doxorubicin hydrochloride IV, vincristine IV, and oral dexamethasone; pegaspargase IM once; and 1 course of cyclophosphamide IV, cytarabine IV, and oral thioguanine.
- High-risk disease*: Patients receive 4 courses of doxorubicin hydrochloride IV, vincristine IV, and oral dexamethasone; pegaspargase IM twice; and 2 courses of cyclophosphamide IV, cytarabine IV, and oral thioguanine.
- Maintenance phase: All patients receive oral mercaptopurine daily and methotrexate IV once weekly for up to 2 years after diagnosis.
NOTE: *In addition to those defined in Disease Characteristics, patients who do not achieve remission after induction phase are treated as high-risk disease, patients who achieve remission after induction phase are treated as low-risk disease
PROJECTED ACCRUAL: A total of 550 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| asparaginase | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| daunorubicin hydrochloride | Drug | – |
| dexamethasone | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| mercaptopurine | Drug | – |
| methotrexate | Drug | – |
| pegaspargase | Drug | – |
| prednisolone | Drug | – |
| teniposide | Drug | – |
| thioguanine | Drug | – |
| vincristine sulfate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride
Reduce therapy in low-risk patients without loss of efficacy
Reduce neurological complications
Reduce allergic reactions against asparaginase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gritta Janka-Schaub study chair
Universitätsklinikum Hamburg-Eppendorf
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by Universitätsklinikum Hamburg-Eppendorf at 16 sites in Germany.
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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2013.