Clofarabine or High-Dose Cytarabine and Pegaspargase in Children With ALL
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| ClinicalTrials.gov Identifier: NCT01228331 |
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Recruitment Status :
Recruiting
First Posted : October 26, 2010
Last Update Posted : October 8, 2019
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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 once drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known whether giving clofarabine or high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride is more effective in treating young patients with acute lymphoblastic leukemia.
PURPOSE: This randomized phase II/III trial is studying the side effects of giving clofarabine compared with giving high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride and to see how well it works in treating young patients with T-cell acute lymphoblastic leukemia or precursor B-cell acute lymphoblastic leukemia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia | Drug: Amsacrine Drug: Clofarabine Drug: Cyclophosphamide Drug: Cytarabine Drug: Daunorubicin hydrochloride Drug: Dexamethasone Drug: Doxorubicin hydrochloride Drug: Etoposide phosphate Drug: Mercaptopurine Drug: Methotrexate Drug: Methylprednisolone Drug: Pegaspargase Drug: Thioguanine Drug: Vincristine sulfate Radiation: Whole-brain radiation therapy | Phase 2 Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 660 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children With Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology |
| Study Start Date : | October 2010 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I intensification (cytarabine)
LR-S patients receive HD cytarabine IV 4 x 3 g over 12 hours daily on days 29-31 and pegaspargase IV over 2 hours on days 31, 52, and 80. LR-I and precursor B-cell ALL HR-S and HR-I patients receive HD cytarabine IV 2.500 over 3 hours twice daily on days 29-31 and 106-108 and pegaspargase IV over 2 hours on days 31, 53, 67, and 108. Followed by standard consolidation therapy regarding to stratification containing: methotrexate, cyclophosphamide, thioguanin, mercaptopurine, etoposide phosphate, amsacrine, cytarabine, methylprednisolone, dexamethasone, vincristine sulfate; whole-brain radiation therapy only if indicated in patients with cns involvement or T-cell ALL |
Drug: Amsacrine
one block amsacrine together with etoposide and methylprednisolone for very high risk patients Drug: Cyclophosphamide together wit MTX and ASP in consolidation and together with cytarabine and 6-TG in reinduction Drug: Cytarabine part of different chemotherapy blocks in consolidation and reinduction Drug: Dexamethasone part of reinduction therapy Drug: Etoposide phosphate part of different chemotherapy blocks Drug: Methotrexate part of different chemotherapy blocks Drug: Methylprednisolone part of different chemotherapy blocks Drug: Pegaspargase part of different chemotherapy blocks Drug: Thioguanine part of different chemotherapy blocks Drug: Vincristine sulfate part of intravenous chemotherapy Radiation: Whole-brain radiation therapy patients with initial cns involvement receive cranial irradiation |
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Active Comparator: Arm II intensification (clofarabine)
LR-S patients receive clofarabine* IV 5 x 40 mg over 2 hours every day on days 29-33 and pegaspargase IV over 2 hours on days 33, 52, and 80. LR-I and precursor B-cell ALL HR-S and HR-I patients receive clofarabine* IV over 2 hours on days 29-33 and pegaspargase IV over 2 hours on days 33, 53, 67, and 108. Followed by standard consolidation therapy regarding to stratification containing: methotrexate, cyclophosphamide, thioguanin, mercaptopurine, etoposide phosphate, amsacrine, cytarabine, methylprednisolone, dexamethasone, vincristine sulfate; whole-brain radiation therapy only if indicated in patients with cns involvement or T-cell ALL |
Drug: Amsacrine
one block amsacrine together with etoposide and methylprednisolone for very high risk patients Drug: Clofarabine one block clofarabine with Asparaginase for MRD positive patients after induction Drug: Cyclophosphamide together wit MTX and ASP in consolidation and together with cytarabine and 6-TG in reinduction Drug: Daunorubicin hydrochloride part of induction and reinduction therapy Drug: Dexamethasone part of reinduction therapy Drug: Etoposide phosphate part of different chemotherapy blocks Drug: Methotrexate part of different chemotherapy blocks Drug: Methylprednisolone part of different chemotherapy blocks Drug: Pegaspargase part of different chemotherapy blocks Drug: Thioguanine part of different chemotherapy blocks Drug: Vincristine sulfate part of intravenous chemotherapy Radiation: Whole-brain radiation therapy patients with initial cns involvement receive cranial irradiation |
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Active Comparator: Arm III reinduct.(doxorubicin hydrochl.)
LR-S patients receive doxorubicin hydrochloride IV 30 mg/m2 over 24 hours on days 1 and 8. LR-I, HR-S and HR-I Patients receive doxorubicin hydrochloride IV 30 mg/m2 over 24 hours on days 1, 8, 22, and 29. Followed by standard reinduction and maintenance therapy containing: cyclophophamide, cytarabine, thioguanine, mercaptopurine, methotrexate and pegaspargase, dexamethasone, vincristine sulfate |
Drug: Cyclophosphamide
together wit MTX and ASP in consolidation and together with cytarabine and 6-TG in reinduction Drug: Cytarabine part of different chemotherapy blocks in consolidation and reinduction Drug: Dexamethasone part of reinduction therapy Drug: Doxorubicin hydrochloride part of reinduction therapy Drug: Mercaptopurine part of different chemotherapy blocks Drug: Methotrexate part of different chemotherapy blocks Drug: Pegaspargase part of different chemotherapy blocks Drug: Vincristine sulfate part of intravenous chemotherapy |
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Active Comparator: Arm IV reinduct.(daunorubicin hydrochl.)
LR-S patients receive daunorubicin hydrochloride IV 36 mg/m2 over 24 hours on days 1 and 8. LR-I, HR-S and HR-I Patients receive daunorubicin hydrochloride IV 36 mg/m2 over 24 hours on days 1, 8, 22, and 29. Followed by standard reinduction and maintenance therapy containing: cyclophophamide, cytarabine, thioguanine, mercaptopurine, methotrexate and pegaspargase, dexamethasone, vincristine sulfate |
Drug: Cyclophosphamide
together wit MTX and ASP in consolidation and together with cytarabine and 6-TG in reinduction Drug: Cytarabine part of different chemotherapy blocks in consolidation and reinduction Drug: Daunorubicin hydrochloride part of induction and reinduction therapy Drug: Dexamethasone part of reinduction therapy Drug: Mercaptopurine part of different chemotherapy blocks Drug: Methotrexate part of different chemotherapy blocks Drug: Pegaspargase part of different chemotherapy blocks Drug: Vincristine sulfate part of intravenous chemotherapy |
- Safety and efficacy of clofarabine combined with pegaspargase (phase II) [ Time Frame: at day 21 after chemotherapy ]minimal residual disease diagnostic, toxicity form
- Incidence of infectious complications after administration of daunorubicin hydrochloride vs doxorubicin hydrochloride [ Time Frame: at the end of reinduction therapy ]toxicity form
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| Ages Eligible for Study: | 1 Year to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
diagnosis after the first and before the 18th birthday AND confirmed diagnosis of acute B-precursor or or T-cell leukemia AND parents or guardians/patients give consent for inclusion in the study and transmission of data AND if none of exclusion criteria is accomplished
Exclusion criteria:
BCR/ABL rearrangement positive OR prior cytostatic treatment lasting > 7 days or prior treatment with cytostatic drugs other than vincristine, daunorubicin and prednisone OR prior severe illnesses which make treatment per the protocol impossible from the outset (BUT trisomy 21 is not an exclusion criterion) OR absence of the baseline data required for assignment to a risk group in accordance with the protocol (BUT patients for whom the MRD value could not be determined for technical reasons will be treated as protocol patients) OR the disease is a secondary malignancy or relapse OR death before the start of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228331
| Germany | |
| Krankenanstalten Gilead gCmbH Neurochirurgische Klinik | Recruiting |
| Bielefeld, Germany, 33617 | |
| Contact: Contact Person 49-521-144-2728 | |
| Klinikum Bremen-Mitte | Recruiting |
| Bremen, Germany, D-28205 | |
| Contact: Contact Person 49-421-497-5413 | |
| Universitaetsklinikum Duesseldorf | Recruiting |
| Duesseldorf, Germany, D-40225 | |
| Contact: Contact Person 49-211-81-17662 | |
| Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald | Recruiting |
| Greifswald, Germany, 17487 | |
| Contact: Contact Person 49-3834-86-6321 | |
| University Medical Center Hamburg - Eppendorf | Recruiting |
| Hamburg, Germany, D-20246 | |
| Contact: Contact Person 49-407-4105-2580 horstmann@uke.uni-hamburg.de | |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | Recruiting |
| Idar-Oberstein, Germany, D-55743 | |
| Contact: Contact Person 49-6781-66-1582 | |
| Klinikum Krefeld GmbH | Recruiting |
| Krefeld, Germany, D-47805 | |
| Contact: Contact Person 49-2151-322-375 | |
| Universitaets - Kinderklinik | Recruiting |
| Leipzig, Germany, D-04317 | |
| Contact: Contact Person 49-341-9726-113 | |
| Johannes Gutenberg University | Recruiting |
| Mainz, Germany, D-55101 | |
| Contact: Contact Person 49-6131-17-2642 | |
| Dr. von Haunersches Kinderspital der Universitaet Muenchen | Recruiting |
| Munich, Germany, D-80337 | |
| Contact: Contact Person 49-89-5160-2843 | |
| Staedtisches Krankenhaus Muenchen - Harlaching | Recruiting |
| Munich, Germany, D-81545 | |
| Contact: Contact Person 49-89-6210-2720 | |
| Klinik St. Hedwig-Kinderklinik | Recruiting |
| Regensburg, Germany, 93049 | |
| Contact: Contact Person 49-941-2080-493 | |
| Dr. Horst-Schmidt-Kliniken | Recruiting |
| Wiesbaden, Germany, D-65199 | |
| Contact: Contact Person 49-611-43-2564 | |
| Helios Kliniken Wuppertal University Hospital | Recruiting |
| Wuppertal, Germany, D-42283 | |
| Contact: Contact Person 49-202-896-2444 | |
| Principal Investigator: | Martin Horstmann, MD | Universitätsklinikum Hamburg-Eppendorf |
Additional Information:
| Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT01228331 History of Changes |
| Other Study ID Numbers: |
CDR0000686545 2009-012758-18 ( EudraCT Number ) |
| First Posted: | October 26, 2010 Key Record Dates |
| Last Update Posted: | October 8, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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childhood acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia |
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Leukemia Neoplasms by Histologic Type Neoplasms Cytarabine Dexamethasone Dexamethasone acetate Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Cyclophosphamide Doxorubicin Liposomal doxorubicin Methotrexate |
Etoposide Etoposide phosphate Vincristine Daunorubicin Clofarabine Mercaptopurine Pegaspargase Asparaginase Thioguanine Amsacrine Prednisolone hemisuccinate Prednisolone phosphate BB 1101 Anti-Inflammatory Agents Antiemetics |