Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00004228 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : December 5, 2013
Last Update Posted : August 6, 2019
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.
PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy | Phase 3 |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 393 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma |
| Study Start Date : | June 2000 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | March 31, 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A0 (localized disease Stg I/II) Modified CCG BFM
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
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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: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: prednisone Given IV
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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Experimental: A1 (Disseminated, No CNS - CCG mod BFM w/out intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
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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: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: prednisone Given IV
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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Experimental: A2 (Disseminated, No CNS - CCG mod BFM w/ intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
|
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: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: prednisone Given IV
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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Experimental: B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
|
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: leucovorin calcium Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: prednisone Given IV
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
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Experimental: B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
|
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: leucovorin calcium Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: prednisone Given IV
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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|
Experimental: B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
|
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: leucovorin calcium Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: prednisone Given IV
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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|
Experimental: B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
|
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: leucovorin calcium Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: prednisone Given IV
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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- Event-free Survival [ Time Frame: 5 years ]Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
- Percentage of Patients With Overall Survival as Assessed by Time to Death [ Time Frame: 5 years ]Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
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| Ages Eligible for Study: | 1 Year to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma*
- Less than 25% tumor cells in the bone marrow
- Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
- Stage III or IV disease
- NOTE: *Localized lymphoblastic lymphoma is closed to accrual as of 10/2005
PATIENT CHARACTERISTICS:
Age:
- 1 to 30
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- Adequate cardiac function
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy
Radiotherapy:
- Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy
Surgery:
- Not specified
Other:
- No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
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): NCT00004228
Show 176 study locations
| Study Chair: | Minnie Abromowitch, MD | Children's Hospital Medical Center, Cincinnati |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00004228 |
| Other Study ID Numbers: |
A5971 CCG-59701 ( Other Identifier: Children's Cancer Group ) CCG-59701C ( Other Identifier: Children's Cancer Group ) CCG-A5971 ( Other Identifier: Children's Cancer Group ) POG-A5971 ( Other Identifier: Pediatric Oncology Group ) CDR0000067470 ( Other Identifier: Clinical Trials.gov ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | December 5, 2013 |
| Last Update Posted: | August 6, 2019 |
| Last Verified: | November 2016 |
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stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma |
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Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Leukemia Leucovorin Cytarabine Dexamethasone Prednisone |
Cyclophosphamide Doxorubicin Liposomal doxorubicin Methotrexate Vincristine Daunorubicin Asparaginase Mercaptopurine Thioguanine Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating |

