Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
NCT ID: NCT00057811
Last Updated: 2014-09-19
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
97 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-06-30
Study Completion Date
2014-07-31
Brief Summary
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Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.
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Detailed Description
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OBJECTIVES:
I. Determine the toxicity of the addition of rituximab to induction chemotherapy comprising vincristine, methylprednisolone, methotrexate, leucovorin calcium, cyclophosphamide, and doxorubicin (COPADM) \[COMRAP\] and to consolidation chemotherapy in children with newly diagnosed FAB prognostic group B or group C leukemia or lymphoma treated with LMB/FAB therapy.
II. Determine the toxicity of the addition of rasburicase to the reduction phase comprising cyclophosphamide, vincristine, prednisone or methylprednisolone, methotrexate, and leucovorin calcium (COP-R) in these patients.
III. Determine the incidence of tumor lysis syndrome, renal complications, and the use of assisted renal support (i.e., dialysis or hemofiltration) during the COP-R reduction phase and the first induction phase of COPADM or COMRAP in these patients.
IV. Determine the response rate of patients treated with COMRAP incorporated into LMB/FAB therapy.
V. Assess minimal residual disease in patients before and during COMRAP therapy incorporated into LMB/FAB therapy.
OUTLINE: This is a multicenter study. Patients are stratified according to FAB prognostic group (B vs C) and treated by group classification.
FAB GROUP B
TREATMENT I (first 6 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen comprising cyclophosphamide IV over 15 minutes, vincristine IV, and methotrexate and hydrocortisone intrathecally (IT) on day 0; rasburicase\* IV over 30 minutes every 12 hours on days 0 and 1 and then once daily on days 2-4 (patients exhibiting hyperuricemia and clinical suspicion of B-cell non-Hodgkin's lymphoma or B-cell acute lymphocytic leukemia also receive rasburicase on days -3, -2, and -1); leucovorin calcium IV or orally every 12 hours on days 1 and 3; and prednisone (PRED) or methylprednisolone (MePRDL) IV (or orally) on days 0-6. Patients too critical to proceed may receive another course of reduction therapy.
NOTE: \*Patients with G6PD deficiency do not receive rasburicase during reduction therapy.
INDUCTION THERAPY: Patients with less than 20% tumor reduction follow the group C induction phase (described below). Patients with at least 20% tumor reduction receive 1 course of the COPADM regimen: vincristine IV and methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; leucovorin calcium IV or orally every 6 hours for 12 doses on days 1-3; doxorubicin IV over 30-60 minutes on day 1; cyclophosphamide IV over 15 minutes every 12 hours on days 1-3; methotrexate IT and hydrocortisone IT on days 1 and 5; and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover.
Patients receive the second part of induction therapy when peripheral blood counts have recovered but no fewer than 16 days after the first part of induction therapy. Patients receive 1 course of the COMRAP regimen comprising rituximab IV on days -2 and 0 with COPADM as in the first part of induction therapy.
CONSOLIDATION THERAPY: Patients receive the CYM-RM regimen comprising rituximab IV and methotrexate IV over 4 hours on day 0; leucovorin calcium IV or orally every 6 hours for 12 doses on days 1-3; cytarabine IV over 24 hours daily on days 1-5; hydrocortisone IT on days 1 and 6; methotrexate IT on day 1; and cytarabine IT on day 6.
After full recovery from consolidation therapy, patients with any residual masses undergo surgical excision or biopsy. Patients with histology positive for tumor (even if completely resected) proceed to Group C consolidation therapy (described below). Patients with histology negative for tumor proceed to Group B maintenance therapy.
MAINTENANCE THERAPY: Patients receive the COPADM regimen comprising vincristine IV and methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; doxorubicin IV over 30-60 minutes, and cyclophosphamide IV over 30 minutes on days 1 and 2; methotrexate IT and hydrocortisone IT on day 1; and leucovorin calcium IV or orally every 6 hours on days 1-3 (12 doses).
TREATMENT II (44 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen as in treatment I.
INDUCTION THERAPY: Patients receive 2 courses of the COMRAP regimen as in the second induction of treatment I.
CONSOLIDATION THERAPY: Patients receive the CYM-RM regimen as in treatment I.
MAINTENANCE THERAPY: Patients receive the COPADM regimen as in treatment I.
FAB GROUP C:
TREATMENT I (first 3 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen as in group B treatment I, with the addition of triple intrathecal therapy (TIT) comprising methotrexate, hydrocortisone, and cytarabine on days 0, 2, and 4.
INDUCTION THERAPY: Patients receive 2 courses of the COPADM regimen as in group B treatment I, with the addition of TIT on days 1, 3, and 5. Patients in group C who have biopsy-proven disease after induction therapy are off protocol therapy and treated at the discretion of the investigator.
CONSOLIDATION THERAPY:
CNS-POSITIVE DISEASE: Patients receive 2 courses of the CYVE-RM regimen comprising rituximab IV and methotrexate and hydrocortisone IT on day 0; cytarabine IV over 12 hours on days 0-4; high-dose cytarabine IV over 3 hours and etoposide IV over 2 hours on days 1-4; and G-CSF SC on days 6-20. During the first course, patients also receive HD-MTX IV over 4 hours on day 17; TIT on day 18; and leucovorin calcium IV or orally every 6 hours on days 18-21 (12 doses).
CNS-NEGATIVE DISEASE: Patients receive the CYVE-RM regimen without intrathecal therapy, HD-MTX, or leucovorin calcium.
After full recovery from consolidation therapy, patients with any residual masses undergo surgical excision or biopsy. Patients who do not achieve complete remission after consolidation therapy are considered treatment failures.
MAINTENANCE THERAPY (each course lasts 28 days):
COURSE M1: Patients receive vincristine IV and high-dose methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; doxorubicin IV over 30-60 minutes and TIT on day 1; cyclophosphamide IV over 30 minutes on days 1 and 2; and leucovorin calcium IV or orally every 6 hours on days 1-4 (12 doses).
COURSE M2: Patients receive etoposide IV over 90 minutes on days 0-2 and cytarabine SC every 12 hours on days 0-4.
COURSE M3: Patients receive vincristine IV on day 0; cyclophosphamide IV over 30 minutes on days 0 and 1; PRED or MePRDL IV (or orally) twice daily on days 0-7; and doxorubicin IV over 30-60 minutes on day 0 (after first dose of cyclophosphamide).
COURSE M4: Patients receive etoposide and cytarabine as in course M2.
TREATMENT II (37 patients):
REDUCTION THERAPY: Patients receive 2 courses of the COP-R regimen as in group C treatment I.
INDUCTION THERAPY: Patients receive the COMRAP regimen comprising rituximab IV, vincristine IV, and HD-MTX IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; leucovorin calcium IV or orally and cyclophosphamide IV over 15 minutes on days 1-3; doxorubicin IV over 30-60 minutes on day 1; TIT on days 1, 3, and 5; and G-CSF SC on days 6-20.
CONSOLIDATION THERAPY: CNS-positive disease: Patients receive the CYVE-RM regimen plus HD-MTX as in group C treatment I. Patients then receive CYVE-RM for a second course.
CNS-NEGATIVE DISEASE: Patients receive CYVE-RM regimen as in group C treatment I.
MAINTENANCE THERAPY: Patients receive maintenance therapy as in group C treatment I.
Patients are followed every 3-6 months for 1 year and then every 6 months for up to 5 years
I. Determine the toxicity of the addition of rituximab to induction chemotherapy comprising vincristine, methylprednisolone, methotrexate, leucovorin calcium, cyclophosphamide, and doxorubicin (COPADM) \[COMRAP\] and to consolidation chemotherapy in children with newly diagnosed FAB prognostic group B or group C leukemia or lymphoma treated with LMB/FAB therapy.
II. Determine the toxicity of the addition of rasburicase to the reduction phase comprising cyclophosphamide, vincristine, prednisone or methylprednisolone, methotrexate, and leucovorin calcium (COP-R) in these patients.
III. Determine the incidence of tumor lysis syndrome, renal complications, and the use of assisted renal support (i.e., dialysis or hemofiltration) during the COP-R reduction phase and the first induction phase of COPADM or COMRAP in these patients.
IV. Determine the response rate of patients treated with COMRAP incorporated into LMB/FAB therapy.
V. Assess minimal residual disease in patients before and during COMRAP therapy incorporated into LMB/FAB therapy.
OUTLINE: This is a multicenter study. Patients are stratified according to FAB prognostic group (B vs C) and treated by group classification.
FAB GROUP B
TREATMENT I (first 6 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen comprising cyclophosphamide IV over 15 minutes, vincristine IV, and methotrexate and hydrocortisone intrathecally (IT) on day 0; rasburicase\* IV over 30 minutes every 12 hours on days 0 and 1 and then once daily on days 2-4 (patients exhibiting hyperuricemia and clinical suspicion of B-cell non-Hodgkin's lymphoma or B-cell acute lymphocytic leukemia also receive rasburicase on days -3, -2, and -1); leucovorin calcium IV or orally every 12 hours on days 1 and 3; and prednisone (PRED) or methylprednisolone (MePRDL) IV (or orally) on days 0-6. Patients too critical to proceed may receive another course of reduction therapy.
NOTE: \*Patients with G6PD deficiency do not receive rasburicase during reduction therapy.
INDUCTION THERAPY: Patients with less than 20% tumor reduction follow the group C induction phase (described below). Patients with at least 20% tumor reduction receive 1 course of the COPADM regimen: vincristine IV and methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; leucovorin calcium IV or orally every 6 hours for 12 doses on days 1-3; doxorubicin IV over 30-60 minutes on day 1; cyclophosphamide IV over 15 minutes every 12 hours on days 1-3; methotrexate IT and hydrocortisone IT on days 1 and 5; and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover.
Patients receive the second part of induction therapy when peripheral blood counts have recovered but no fewer than 16 days after the first part of induction therapy. Patients receive 1 course of the COMRAP regimen comprising rituximab IV on days -2 and 0 with COPADM as in the first part of induction therapy.
CONSOLIDATION THERAPY: Patients receive the CYM-RM regimen comprising rituximab IV and methotrexate IV over 4 hours on day 0; leucovorin calcium IV or orally every 6 hours for 12 doses on days 1-3; cytarabine IV over 24 hours daily on days 1-5; hydrocortisone IT on days 1 and 6; methotrexate IT on day 1; and cytarabine IT on day 6.
After full recovery from consolidation therapy, patients with any residual masses undergo surgical excision or biopsy. Patients with histology positive for tumor (even if completely resected) proceed to Group C consolidation therapy (described below). Patients with histology negative for tumor proceed to Group B maintenance therapy.
MAINTENANCE THERAPY: Patients receive the COPADM regimen comprising vincristine IV and methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; doxorubicin IV over 30-60 minutes, and cyclophosphamide IV over 30 minutes on days 1 and 2; methotrexate IT and hydrocortisone IT on day 1; and leucovorin calcium IV or orally every 6 hours on days 1-3 (12 doses).
TREATMENT II (44 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen as in treatment I.
INDUCTION THERAPY: Patients receive 2 courses of the COMRAP regimen as in the second induction of treatment I.
CONSOLIDATION THERAPY: Patients receive the CYM-RM regimen as in treatment I.
MAINTENANCE THERAPY: Patients receive the COPADM regimen as in treatment I.
FAB GROUP C:
TREATMENT I (first 3 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen as in group B treatment I, with the addition of triple intrathecal therapy (TIT) comprising methotrexate, hydrocortisone, and cytarabine on days 0, 2, and 4.
INDUCTION THERAPY: Patients receive 2 courses of the COPADM regimen as in group B treatment I, with the addition of TIT on days 1, 3, and 5. Patients in group C who have biopsy-proven disease after induction therapy are off protocol therapy and treated at the discretion of the investigator.
CONSOLIDATION THERAPY:
CNS-POSITIVE DISEASE: Patients receive 2 courses of the CYVE-RM regimen comprising rituximab IV and methotrexate and hydrocortisone IT on day 0; cytarabine IV over 12 hours on days 0-4; high-dose cytarabine IV over 3 hours and etoposide IV over 2 hours on days 1-4; and G-CSF SC on days 6-20. During the first course, patients also receive HD-MTX IV over 4 hours on day 17; TIT on day 18; and leucovorin calcium IV or orally every 6 hours on days 18-21 (12 doses).
CNS-NEGATIVE DISEASE: Patients receive the CYVE-RM regimen without intrathecal therapy, HD-MTX, or leucovorin calcium.
After full recovery from consolidation therapy, patients with any residual masses undergo surgical excision or biopsy. Patients who do not achieve complete remission after consolidation therapy are considered treatment failures.
MAINTENANCE THERAPY (each course lasts 28 days):
COURSE M1: Patients receive vincristine IV and high-dose methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; doxorubicin IV over 30-60 minutes and TIT on day 1; cyclophosphamide IV over 30 minutes on days 1 and 2; and leucovorin calcium IV or orally every 6 hours on days 1-4 (12 doses).
COURSE M2: Patients receive etoposide IV over 90 minutes on days 0-2 and cytarabine SC every 12 hours on days 0-4.
COURSE M3: Patients receive vincristine IV on day 0; cyclophosphamide IV over 30 minutes on days 0 and 1; PRED or MePRDL IV (or orally) twice daily on days 0-7; and doxorubicin IV over 30-60 minutes on day 0 (after first dose of cyclophosphamide).
COURSE M4: Patients receive etoposide and cytarabine as in course M2.
TREATMENT II (37 patients):
REDUCTION THERAPY: Patients receive 2 courses of the COP-R regimen as in group C treatment I.
INDUCTION THERAPY: Patients receive the COMRAP regimen comprising rituximab IV, vincristine IV, and HD-MTX IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; leucovorin calcium IV or orally and cyclophosphamide IV over 15 minutes on days 1-3; doxorubicin IV over 30-60 minutes on day 1; TIT on days 1, 3, and 5; and G-CSF SC on days 6-20.
CONSOLIDATION THERAPY: CNS-positive disease: Patients receive the CYVE-RM regimen plus HD-MTX as in group C treatment I. Patients then receive CYVE-RM for a second course.
CNS-NEGATIVE DISEASE: Patients receive CYVE-RM regimen as in group C treatment I.
MAINTENANCE THERAPY: Patients receive maintenance therapy as in group C treatment I.
Patients are followed every 3-6 months for 1 year and then every 6 months for up to 5 years
Conditions
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Childhood Burkitt Lymphoma
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Stage I Childhood Large Cell Lymphoma
Stage I Childhood Small Noncleaved Cell Lymphoma
Stage II Childhood Large Cell Lymphoma
Stage II Childhood Small Noncleaved Cell Lymphoma
Stage III Childhood Large Cell Lymphoma
Stage III Childhood Small Noncleaved Cell Lymphoma
Stage IV Childhood Large Cell Lymphoma
Stage IV Childhood Small Noncleaved Cell Lymphoma
Untreated Childhood Acute Lymphoblastic Leukemia
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Group B (chemotherapy, protective therapy, monoclonal antib.)
Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
Group Type
EXPERIMENTAL
doxorubicin hydrochloride
Intervention Type
DRUG
Given IV, IT, or orally
cyclophosphamide
Intervention Type
DRUG
Given IV
methotrexate
Intervention Type
DRUG
Given IV or IT
rasburicase
Intervention Type
DRUG
Given IV
leucovorin calcium
Intervention Type
DRUG
Given IV or orally
prednisone
Intervention Type
DRUG
Given IV or orally
methylprednisolone
Intervention Type
DRUG
Given IV or orally
filgrastim
Intervention Type
BIOLOGICAL
Given subcutaneously
rituximab
Intervention Type
BIOLOGICAL
Given IV
cytarabine
Intervention Type
DRUG
Given IT
vincristine sulfate
Intervention Type
DRUG
Given IV
hydrocortisone sodium succinate
Intervention Type
DRUG
Given IT
laboratory biomarker analysis
Intervention Type
OTHER
Correlative studies
Group C (Chemotherapy, monoclonal antibody therapy)
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Group Type
EXPERIMENTAL
doxorubicin hydrochloride
Intervention Type
DRUG
Given IV, IT, or orally
cyclophosphamide
Intervention Type
DRUG
Given IV
methotrexate
Intervention Type
DRUG
Given IV or IT
leucovorin calcium
Intervention Type
DRUG
Given IV or orally
prednisone
Intervention Type
DRUG
Given IV or orally
methylprednisolone
Intervention Type
DRUG
Given IV or orally
filgrastim
Intervention Type
BIOLOGICAL
Given subcutaneously
rituximab
Intervention Type
BIOLOGICAL
Given IV
cytarabine
Intervention Type
DRUG
Given IT
etoposide
Intervention Type
DRUG
Given IV
vincristine sulfate
Intervention Type
DRUG
Given IV
hydrocortisone sodium succinate
Intervention Type
DRUG
Given IT
laboratory biomarker analysis
Intervention Type
OTHER
Correlative studies
Interventions
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doxorubicin hydrochloride
Given IV, IT, or orally
Intervention Type
DRUG
cyclophosphamide
Given IV
Intervention Type
DRUG
methotrexate
Given IV or IT
Intervention Type
DRUG
rasburicase
Given IV
Intervention Type
DRUG
leucovorin calcium
Given IV or orally
Intervention Type
DRUG
prednisone
Given IV or orally
Intervention Type
DRUG
methylprednisolone
Given IV or orally
Intervention Type
DRUG
filgrastim
Given subcutaneously
Intervention Type
BIOLOGICAL
rituximab
Given IV
Intervention Type
BIOLOGICAL
cytarabine
Given IT
Intervention Type
DRUG
etoposide
Given IV
Intervention Type
DRUG
vincristine sulfate
Given IV
Intervention Type
DRUG
hydrocortisone sodium succinate
Given IT
Intervention Type
DRUG
laboratory biomarker analysis
Correlative studies
Intervention Type
OTHER
Other Intervention Names
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ADM
ADR
Adria
Adriamycin PFS
Adriamycin RDF
CPM
CTX
Cytoxan
Endoxan
Endoxana
amethopterin
Folex
methylaminopterin
Mexate
MTX
Elitek
NK-631
recombinant urate oxidase
CF
CFR
LV
DeCortin
Deltra
Depo-Medrol
Medrol
MePRDL
Solu-Medrol
Wyacort
G-CSF
Neupogen
IDEC-C2B8
IDEC-C2B8 monoclonal antibody
Mabthera
MOAB IDEC-C2B8
Rituxan
ARA-C
arabinofuranosylcytosine
arabinosylcytosine
Cytosar-U
cytosine arabinoside
EPEG
VP-16
VP-16-213
leurocristine sulfate
VCR
Vincasar PFS
Sodium hydrocortisone succinate
Solu-Cortef
Solu-Glyc
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL classification of 1 of the following subtypes:
* Diffuse large cell lymphoma
* Burkitt's lymphoma
* High-grade B-cell lymphoma (Burkitt-like)
* No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas
* One of the following FAB prognostic groups:
* Group B (intermediate risk)
* Group C (high risk)
* Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following criteria:
* Any L3 blasts in cerebrospinal fluid
* Cranial nerve palsy (if not explained by extracranial tumor)
* Clinical spinal cord compression
* Isolated intracerebral mass
* Parameningeal extension (cranial and/or spinal)
* Hepatitis B status known
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No known history of congenital immune deficiency and/or laboratory evidence of acquired immune deficiency
* No known G6PD deficiency (if receiving rasburicase)
* No prior malignancies treated with systemic chemotherapy with alkylator or anthracycline therapy
* No prior chemotherapy
* At least 1 week since prior steroids except emergency steroids initiated within 72 hours of study entry
* No prior radiotherapy except emergency radiotherapy initiated within 72 hours of study entry
* No concurrent radiotherapy
* No prior solid organ transplantation
* Diffuse large cell lymphoma
* Burkitt's lymphoma
* High-grade B-cell lymphoma (Burkitt-like)
* No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas
* One of the following FAB prognostic groups:
* Group B (intermediate risk)
* Group C (high risk)
* Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following criteria:
* Any L3 blasts in cerebrospinal fluid
* Cranial nerve palsy (if not explained by extracranial tumor)
* Clinical spinal cord compression
* Isolated intracerebral mass
* Parameningeal extension (cranial and/or spinal)
* Hepatitis B status known
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No known history of congenital immune deficiency and/or laboratory evidence of acquired immune deficiency
* No known G6PD deficiency (if receiving rasburicase)
* No prior malignancies treated with systemic chemotherapy with alkylator or anthracycline therapy
* No prior chemotherapy
* At least 1 week since prior steroids except emergency steroids initiated within 72 hours of study entry
* No prior radiotherapy except emergency radiotherapy initiated within 72 hours of study entry
* No concurrent radiotherapy
* No prior solid organ transplantation
Minimum Eligible Age
1 Year
Maximum Eligible Age
29 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Children's Oncology Group
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mitchell Cairo, MD CCRP
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Oncology Group
Arcadia, California, United States
Site Status
Countries
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United States
References
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Shiramizu B, Goldman S, Kusao I, Agsalda M, Lynch J, Smith L, Harrison L, Morris E, Gross TG, Sanger W, Perkins S, Cairo MS. Minimal disease assessment in the treatment of children and adolescents with intermediate-risk (Stage III/IV) B-cell non-Hodgkin lymphoma: a children's oncology group report. Br J Haematol. 2011 Jun;153(6):758-63. doi: 10.1111/j.1365-2141.2011.08681.x. Epub 2011 Apr 18.
Reference Type
BACKGROUND
Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available.
Reference Type
DERIVED
Other Identifiers
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NCI-2009-00405
Identifier Type: REGISTRY
Identifier Source: secondary_id
COG-ANHL01P1
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000271941
Identifier Type: OTHER
Identifier Source: secondary_id
ANHL01P1
Identifier Type: -
Identifier Source: org_study_id
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Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
NCT00004228
COMPLETED
PHASE3
Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkin's Lymphoma
NCT00002691
COMPLETED
PHASE2
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
NCT05518383
RECRUITING
PHASE4
MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia
NCT01231919
COMPLETED
PHASE1
TITLE:Less Intensive Therapy for Children With Non-Hodgkin's Lymphoma
NCT00002757
COMPLETED
PHASE3
Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
NCT00137111
COMPLETED
PHASE3
Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
NCT01026220
COMPLETED
PHASE3
A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)
NCT03743246
TERMINATED
PHASE1/PHASE2
Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma
NCT00317408
UNKNOWN
NA
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma
NCT00002941
COMPLETED
PHASE2
Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT00873093
COMPLETED
PHASE2
Combination Chemotherapy With or Without Radiation Therapy and Peripheral Stem Cell Transplant in Treating Children With Hodgkin's Lymphoma
NCT00025064
UNKNOWN
PHASE2
LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma
NCT00085150
COMPLETED
PHASE1
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
NCT05761171
ACTIVE_NOT_RECRUITING
PHASE2