Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
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| ClinicalTrials.gov Identifier: NCT00002812 |
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Recruitment Status :
Completed
First Posted : November 24, 2003
Last Update Posted : August 26, 2013
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief 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 and giving the drugs in different combinations may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia | Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2078 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study |
| Study Start Date : | September 1996 |
| Actual Primary Completion Date : | March 2006 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A - Standard BFM of Standard Duration (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow. Consolidation (Phase II) (5 weeks) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
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Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
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Experimental: Arm B - Standard BFM with Double Delayed Intensification (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (5 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
|
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
|
Experimental: Arm C - Augumented BFM of Standard Duration (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
|
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
|
Experimental: Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
|
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
Primary Outcome Measures :
- Event Free Survival [ Time Frame: from the time of randomization where the life table events will consist of the first occurrence of the following events: failure to achieve remission, leukemic relapse at any site, death, or occurrence of a second malignancy. ]The primary outcome index used in examining most of the randomized treatment groups will be event-free survival (EFS).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 1 Year to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS: Acute lymphocytic leukemia (ALL) with M3 bone marrow No FAB L3 morphology CNS or overt testicular leukemia at diagnosis allowed High risk status 10-21 years old with any white blood count (WBC) 1-9 years old with WBC of 50,000/mm3 or greater
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: No prior therapy for ALL except: Emergency therapy for blast crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration Biologic therapy: Not specified Chemotherapy: Intrathecal cytarabine or methotrexate allowed at diagnostic lumbar puncture Induction therapy must begin within 72 hours after intrathecal injection Endocrine therapy: At least 1-2 months since prior prednisone, for less than 48 hours, for reactive airway disease Inhalational steroids allowed Radiotherapy: Not specified Surgery: Not specified
Information from the National Library of Medicine
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): NCT00002812
Show 35 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | Nita L. Seibel, MD | Children's Research Institute |
Publications of Results:
Arce FJ, Seibel N, Gaynon PS, et al.: Pharmacokinetics and pharmacodynamics of asparaginases in antibody-negative pediatric patients with higher risk acute lymphoblastic leukemia (ALL): a report from CCG-1961. [Abstract] J Clin Oncol 24 (Suppl 18): A-9027, 508s, 2006.
Avramis VI, Ettinger L, Martin-Aragon S, et al.: Anti-asparaginase (ASNase) antibody (Ab) in pediatric patients in high risk ALL study (CCG-1961): correlation of Ab and clinical allergy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2319, 2000.
Avramis VI, Panosyan E, Avramis IA, et al.: Anti-asparaginase (ASNase) antibody (Ab) and ASNase activity in children with higher risk acute lymphoblastic leukemia (HR ALL) (CCG-1961). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1592, 2002.
Dhall G, Jones T, Radvinsky D, et al.: Adverse reactions to PEG and Erwinia asparaginase and correlation with anti-asparaginase antibody data and survival in children with acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group study CCG 1961. [Abstract] Blood 114 (22): A-3077, 2009.
Dhall G, Robison NJ, Rubin JI, et al.: Incidence of adverse reactions to post-induction asparaginase (ASP) therapy in children and adolescents with high-risk acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group Study CCG-1961. [Abstract] J Clin Oncol 26 (Suppl 15): A-10021, 2008.
Freyer DR, Seibel NL, La MK, et al.: Survival after relapse in higher risk acute lymphoblastic leukemia (ALL) in children and adolescents is independent of prior treatment intensity: a report from the Children's Oncology Group (COG). [Abstract] Blood 112 (11): A-917, 2008.
Hastings C, Sather HN, Seibel NL, et al.: Outcomes in children and adolescents with a markedly elevated white blood cell count (>200,000) at diagnosis of high risk acute lymphoblastic leukemia (ALL): a report from the Children's Oncology Group. [Abstract] Blood 108 (11): A-1870, 2006.
Hastings C, Whitlock JA, La M, et al.: Improved outcome of children with Down syndrome (DS) and high risk acute lymphocytic leukemia (HR-ALL): a report of CCG-1961. [Abstract] Blood 110 (11): A-586, 2007.
Nachman J, Siebel N, Sather H, et al.: Outcome for adolescent and young adults 16-21 years of age (AYA) with acute lymphoblastic leukemia (ALL) treated on the Children' s Cancer Group (CCG) 1961 study. [Abstract] Blood 104 (11): A-683, 2004.
Panosyan EH, Seibel NL, Grigoryan RS, et al.: Pharmacokinetics and pharmacodynamics of three asparaginases in pediatric patients with higher risk acute lymphoblastic leukemia: a report from CCG-1961. [Abstract] Blood 104 (11): A-2745, 2004.
Other Publications:
Seibel NL, Asselin BL, Nachman JB, et al.: Treatment of high risk T-cell acute lymphoblastic leukemia (T-ALL): comparison of recent experience of the Children's Cancer Group (CCG) and Pediatric Oncology Group (POG). [Abstract] Blood 104 (11): A-681, 2004.
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002812 History of Changes |
| Other Study ID Numbers: |
1961 CCG-1961 ( Other Identifier: Children's Cancer Group ) CDR0000064953 ( Other Identifier: Clinical Trials.gov ) |
| First Posted: | November 24, 2003 Key Record Dates |
| Last Update Posted: | August 26, 2013 |
| Last Verified: | August 2013 |
Keywords provided by Children's Oncology Group:
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untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone Prednisone Liposomal doxorubicin Pegaspargase Cyclophosphamide Doxorubicin |
Methotrexate Cytarabine Vincristine Daunorubicin Idarubicin Asparaginase 6-Mercaptopurine Thioguanine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids |