Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
NCT ID: NCT00002798
Last Updated: 2013-01-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
880 participants
Study Classification
INTERVENTIONAL
Study Start Date
1996-08-31
Brief Summary
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Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome
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Detailed Description
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OBJECTIVES:
Increase the remission induction rate to greater than 85% in children with untreated acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) by replacing daunorubicin (DNR) with idarubicin (IDA) in intensively timed DCTER chemotherapy (dexamethasone, cytarabine (ARA-C), thioguanine, etoposide, and daunorubicin) in the first 4 days of each course.
Increase the remission rate further by comparing the efficacy of consolidation chemotherapy with intensively timed IDA DCTER/DCTER vs fludarabine (FAMP), ARA-C, and IDA in maintaining remission and in achieving remission in patients with M2 disease (5%-29% blasts in marrow) at the end of induction chemotherapy.
Compare overall survival, event-free survival, and disease-free survival in patients who receive consolidation with IDA DCTER/DCTER vs FAMP, ARA-C, and IDA.
Compare overall survival, event-free survival, and disease-free survival in patients receiving intensification with the Capizzi II regimen (high-dose ARA-C and asparaginase) vs those receiving a matched-related allogeneic bone marrow transplantation.
Compare overall survival, event-free survival, and disease-free survival in patients treated with interleukin-2 (IL-2) vs standard follow up care after Capizzi II intensification.
Determine whether multichannel flow cytometry detection of residual AML on a companion biologic study protocol CCG-B942 predicts outcome, and determine whether any of these treatment regimens eliminates minimal residual disease more effectively than another.
Register all patients with MDS treated or followed at CCG institutions and capture their biologic, historical and outcome data.
Determine, on a companion biologic study protocol CCG-B972, whether levels of IL-2 soluble receptor (sIL-2R) and absolute lymphocyte count (ALC) before, during, and after therapy correlates with outcome.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, diagnosis (acute myelogenous leukemia vs other), and response to induction (partial vs complete remission). After induction, patients with M1/M2 marrow are randomized to arm I or II. Patients in complete remission after consolidation who have an HLA-identical or 1-antigen mismatched sibling or parent donor are randomly assigned to the allogeneic bone marrow transplantation (AlBMT) regimen; all others in complete remission are nonrandomly assigned to the Capizzi II regimen, then are randomly assigned to arms III or IV. Patients with refractory anemia (RA) or RA with ringed sideroblasts with indolent disease may be registered and followed. Other patients with myelodysplastic syndromes may receive 2961 chemotherapy or go directly to AlBMT. Patients with chloromas (granulocytic sarcomas) receive optional radiotherapy on arm V.
Induction: Patients receive idarubicin IV over 30 minutes on days 0-3, cytarabine and etoposide IV continuously on days 0-3, and oral thioguanine twice a day and oral dexamethasone 3 times a day on days 0-3. Patients then begin course 2, which consists of cytarabine, etoposide, thioguanine, and dexamethasone on days 10-13, daunorubicin IV continuously on days 10-13, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 16 and continuing until blood counts recover. Patients also receive CNS prophylaxis/therapy consisting of cytarabine intrathecally (IT) on days 0 and 14 (if no CNS disease at entry) or on days 0, 5, and 7 (if CNS disease present at entry). Disease is reassessed on day 28-42. Patients with M1 or M2 marrow proceed to consolidation while those with M3 marrow or progressive disease go off study.
Consolidation:
Arm I: Patients receive treatment as in induction therapy, plus G-CSF SC beginning on day 16 and continuing until blood counts recover. If CSF is clear by day 10 of induction, patients receive cytarabine IT on days 0, 10, and 35. If CSF is not clear, patients receive triple intrathecal therapy (TIT; cytarabine, hydrocortisone, methotrexate) on days 0 and 10.
Arm II: Patients receive fludarabine IV over 24 hours on days 0 and 1, cytarabine IV over 72 hours on days 2-4, and idarubicin IV over 15 minutes on days 0-2. G-CSF begins on day 6 and continues until blood counts recover. Patients also receive TIT on days -1 and 7, if CSF is not clear on day 10 of induction. Patients on both arms are reassessed on day 35. Those patients with M1 marrow proceed to intensification; all others are removed from the study.
Intensification:
Capizzi II regimen: Course 1: Patients receive cytarabine IV over 3 hours every 12 hours on days 0, 1, 7, and 8 and asparaginase IM on days 1 and 8. Course 2: Patients also receive cytarabine IT or TIT on days 0, 7, and 14.AlBMT regimen: Therapy begins within 2-8 weeks of hematologic recovery. Patients may receive interim therapy consisting of oral thioguanine for about 2 weeks. Patients then receive oral busulfan every 6 hours on days -9 to -6 and cyclophosphamide IV over 1 hour on days -5 to -2. AlBMT is infused over 4 hours beginning 36-48 hours after the last dose of cyclophosphamide. Patients in complete remission after completing the Capizzi II regimen proceed to maintenance therapy on arm III.
Arm III: Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
Arm IV: No further treatment.
Arm V: Patients undergo radiotherapy to the chloroma 5 days a week for 2 weeks.
Patients are followed monthly for 18 months, every 3 months for 1 year, and then every 6 months until 5 years from diagnosis.
PROJECTED ACCRUAL: Approximately 880 patients with de novo acute myelogenous leukemia will be accrued for this study within 4 years. It is expected that 178 patients per year will be randomly assigned for consolidation, that 39 patients per year will undergo allogeneic bone marrow transplantation while 120 patients per year will receive chemotherapy as intensification, and that 102 patients per year will be randomly assigned for polychemotherapy immunomodulation. An additional 80 patients with myelodysplastic syndromes will be accrued for this study.
Increase the remission induction rate to greater than 85% in children with untreated acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) by replacing daunorubicin (DNR) with idarubicin (IDA) in intensively timed DCTER chemotherapy (dexamethasone, cytarabine (ARA-C), thioguanine, etoposide, and daunorubicin) in the first 4 days of each course.
Increase the remission rate further by comparing the efficacy of consolidation chemotherapy with intensively timed IDA DCTER/DCTER vs fludarabine (FAMP), ARA-C, and IDA in maintaining remission and in achieving remission in patients with M2 disease (5%-29% blasts in marrow) at the end of induction chemotherapy.
Compare overall survival, event-free survival, and disease-free survival in patients who receive consolidation with IDA DCTER/DCTER vs FAMP, ARA-C, and IDA.
Compare overall survival, event-free survival, and disease-free survival in patients receiving intensification with the Capizzi II regimen (high-dose ARA-C and asparaginase) vs those receiving a matched-related allogeneic bone marrow transplantation.
Compare overall survival, event-free survival, and disease-free survival in patients treated with interleukin-2 (IL-2) vs standard follow up care after Capizzi II intensification.
Determine whether multichannel flow cytometry detection of residual AML on a companion biologic study protocol CCG-B942 predicts outcome, and determine whether any of these treatment regimens eliminates minimal residual disease more effectively than another.
Register all patients with MDS treated or followed at CCG institutions and capture their biologic, historical and outcome data.
Determine, on a companion biologic study protocol CCG-B972, whether levels of IL-2 soluble receptor (sIL-2R) and absolute lymphocyte count (ALC) before, during, and after therapy correlates with outcome.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, diagnosis (acute myelogenous leukemia vs other), and response to induction (partial vs complete remission). After induction, patients with M1/M2 marrow are randomized to arm I or II. Patients in complete remission after consolidation who have an HLA-identical or 1-antigen mismatched sibling or parent donor are randomly assigned to the allogeneic bone marrow transplantation (AlBMT) regimen; all others in complete remission are nonrandomly assigned to the Capizzi II regimen, then are randomly assigned to arms III or IV. Patients with refractory anemia (RA) or RA with ringed sideroblasts with indolent disease may be registered and followed. Other patients with myelodysplastic syndromes may receive 2961 chemotherapy or go directly to AlBMT. Patients with chloromas (granulocytic sarcomas) receive optional radiotherapy on arm V.
Induction: Patients receive idarubicin IV over 30 minutes on days 0-3, cytarabine and etoposide IV continuously on days 0-3, and oral thioguanine twice a day and oral dexamethasone 3 times a day on days 0-3. Patients then begin course 2, which consists of cytarabine, etoposide, thioguanine, and dexamethasone on days 10-13, daunorubicin IV continuously on days 10-13, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 16 and continuing until blood counts recover. Patients also receive CNS prophylaxis/therapy consisting of cytarabine intrathecally (IT) on days 0 and 14 (if no CNS disease at entry) or on days 0, 5, and 7 (if CNS disease present at entry). Disease is reassessed on day 28-42. Patients with M1 or M2 marrow proceed to consolidation while those with M3 marrow or progressive disease go off study.
Consolidation:
Arm I: Patients receive treatment as in induction therapy, plus G-CSF SC beginning on day 16 and continuing until blood counts recover. If CSF is clear by day 10 of induction, patients receive cytarabine IT on days 0, 10, and 35. If CSF is not clear, patients receive triple intrathecal therapy (TIT; cytarabine, hydrocortisone, methotrexate) on days 0 and 10.
Arm II: Patients receive fludarabine IV over 24 hours on days 0 and 1, cytarabine IV over 72 hours on days 2-4, and idarubicin IV over 15 minutes on days 0-2. G-CSF begins on day 6 and continues until blood counts recover. Patients also receive TIT on days -1 and 7, if CSF is not clear on day 10 of induction. Patients on both arms are reassessed on day 35. Those patients with M1 marrow proceed to intensification; all others are removed from the study.
Intensification:
Capizzi II regimen: Course 1: Patients receive cytarabine IV over 3 hours every 12 hours on days 0, 1, 7, and 8 and asparaginase IM on days 1 and 8. Course 2: Patients also receive cytarabine IT or TIT on days 0, 7, and 14.AlBMT regimen: Therapy begins within 2-8 weeks of hematologic recovery. Patients may receive interim therapy consisting of oral thioguanine for about 2 weeks. Patients then receive oral busulfan every 6 hours on days -9 to -6 and cyclophosphamide IV over 1 hour on days -5 to -2. AlBMT is infused over 4 hours beginning 36-48 hours after the last dose of cyclophosphamide. Patients in complete remission after completing the Capizzi II regimen proceed to maintenance therapy on arm III.
Arm III: Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
Arm IV: No further treatment.
Arm V: Patients undergo radiotherapy to the chloroma 5 days a week for 2 weeks.
Patients are followed monthly for 18 months, every 3 months for 1 year, and then every 6 months until 5 years from diagnosis.
PROJECTED ACCRUAL: Approximately 880 patients with de novo acute myelogenous leukemia will be accrued for this study within 4 years. It is expected that 178 patients per year will be randomly assigned for consolidation, that 39 patients per year will undergo allogeneic bone marrow transplantation while 120 patients per year will receive chemotherapy as intensification, and that 102 patients per year will be randomly assigned for polychemotherapy immunomodulation. An additional 80 patients with myelodysplastic syndromes will be accrued for this study.
Conditions
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Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
Childhood Acute Myelomonocytic Leukemia (M4)
Childhood Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Refractory Anemia
Refractory Anemia With Excess Blasts
Refractory Anemia With Excess Blasts in Transformation
Refractory Anemia With Ringed Sideroblasts
Secondary Myelodysplastic Syndromes
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm I (combination chemotherapy)
Patients receive treatment as in induction therapy, plus G-CSF SC beginning on day 16 and continuing until blood counts recover. If CSF is clear by day 10 of induction, patients receive cytarabine IT on days 0, 10, and 35. If CSF is not clear, patients receive triple intrathecal therapy (TIT; cytarabine, hydrocortisone, methotrexate) on days 0 and 10.
See Detailed Description
Group Type
EXPERIMENTAL
daunorubicin hydrochloride
Intervention Type
DRUG
therapeutic hydrocortisone
Intervention Type
DRUG
allogeneic bone marrow transplantation
Intervention Type
PROCEDURE
filgrastim
Intervention Type
BIOLOGICAL
Given SC
cytarabine
Intervention Type
DRUG
Given IV or IT
idarubicin
Intervention Type
DRUG
Given IV
dexamethasone
Intervention Type
DRUG
Given PO
thioguanine
Intervention Type
DRUG
Given PO
etoposide
Intervention Type
DRUG
Given IV
methotrexate
Intervention Type
DRUG
Given IT
Arm II (combination chemotherapy)
Patients receive fludarabine IV over 24 hours on days 0 and 1, cytarabine IV over 72 hours on days 2-4, and idarubicin IV over 15 minutes on days 0-2. G-CSF begins on day 6 and continues until blood counts recover. Patients also receive TIT on days -1 and 7, if CSF is not clear on day 10 of induction. Patients on both arms are reassessed on day 35. Those patients with M1 marrow proceed to intensification; all others are removed from the study.
Intensification: See Detailed Description
Group Type
EXPERIMENTAL
asparaginase
Intervention Type
DRUG
fludarabine phosphate
Intervention Type
DRUG
therapeutic hydrocortisone
Intervention Type
DRUG
allogeneic bone marrow transplantation
Intervention Type
PROCEDURE
filgrastim
Intervention Type
BIOLOGICAL
Given SC
cytarabine
Intervention Type
DRUG
Given IV or IT
idarubicin
Intervention Type
DRUG
Given IV
thioguanine
Intervention Type
DRUG
Given PO
methotrexate
Intervention Type
DRUG
Given IT
cyclophosphamide
Intervention Type
DRUG
Given IV
busulfan
Intervention Type
DRUG
Arm III (combination chemotherapy, aldesleukin)
Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
Group Type
EXPERIMENTAL
daunorubicin hydrochloride
Intervention Type
DRUG
filgrastim
Intervention Type
BIOLOGICAL
Given SC
cytarabine
Intervention Type
DRUG
Given IV or IT
idarubicin
Intervention Type
DRUG
Given IV
dexamethasone
Intervention Type
DRUG
Given PO
thioguanine
Intervention Type
DRUG
Given PO
etoposide
Intervention Type
DRUG
Given IV
aldesleukin
Intervention Type
BIOLOGICAL
Arm IV (combination chemotherapy)
No further treatment
Group Type
ACTIVE_COMPARATOR
daunorubicin hydrochloride
Intervention Type
DRUG
filgrastim
Intervention Type
BIOLOGICAL
Given SC
cytarabine
Intervention Type
DRUG
Given IV or IT
idarubicin
Intervention Type
DRUG
Given IV
dexamethasone
Intervention Type
DRUG
Given PO
thioguanine
Intervention Type
DRUG
Given PO
etoposide
Intervention Type
DRUG
Given IV
Arm V (combination chemotherapy, radiotherapy)
Patients undergo radiotherapy to the chloroma 5 days a week for 2 weeks.
Group Type
EXPERIMENTAL
daunorubicin hydrochloride
Intervention Type
DRUG
3-dimensional conformal radiation therapy
Intervention Type
RADIATION
filgrastim
Intervention Type
BIOLOGICAL
Given SC
cytarabine
Intervention Type
DRUG
Given IV or IT
idarubicin
Intervention Type
DRUG
Given IV
dexamethasone
Intervention Type
DRUG
Given PO
thioguanine
Intervention Type
DRUG
Given PO
etoposide
Intervention Type
DRUG
Given IV
Interventions
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asparaginase
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
fludarabine phosphate
Intervention Type
DRUG
therapeutic hydrocortisone
Intervention Type
DRUG
allogeneic bone marrow transplantation
Intervention Type
PROCEDURE
3-dimensional conformal radiation therapy
Intervention Type
RADIATION
filgrastim
Given SC
Intervention Type
BIOLOGICAL
cytarabine
Given IV or IT
Intervention Type
DRUG
idarubicin
Given IV
Intervention Type
DRUG
dexamethasone
Given PO
Intervention Type
DRUG
thioguanine
Given PO
Intervention Type
DRUG
etoposide
Given IV
Intervention Type
DRUG
methotrexate
Given IT
Intervention Type
DRUG
cyclophosphamide
Given IV
Intervention Type
DRUG
aldesleukin
Intervention Type
BIOLOGICAL
busulfan
Intervention Type
DRUG
Other Intervention Names
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ASNase
Colaspase
Crasnitin
Elspar
L-ASP
Cerubidin
Cerubidine
daunomycin hydrochloride
daunorubicin
RP-13057
2-F-ara-AMP
Beneflur
Fludara
Aeroseb-HC
Barseb HC
Cetacort
Cort-Dome
Cortef
bone marrow therapy, allogeneic
bone marrow therapy, allogenic
transplantation, allogeneic bone marrow
transplantation, allogenic bone marrow
3D conformal radiation therapy
3D-CRT
G-CSF
Neupogen
ARA-C
arabinofuranosylcytosine
arabinosylcytosine
Cytosar-U
cytosine arabinoside
4-demethoxydaunorubicin
4-DMDR
DMDR
IDA
Aeroseb-Dex
Decaderm
Decadron
DM
DXM
6-TG
EPEG
VP-16
VP-16-213
amethopterin
Folex
methylaminopterin
Mexate
MTX
CPM
CTX
Cytoxan
Endoxan
Endoxana
IL-2
Proleukin
recombinant human interleukin-2
recombinant interleukin-2
BSF
BU
Misulfan
Mitosan
Myeloleukon
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed previously untreated acute myeloid leukemia (AML) in patients 1 month to 21 years of age
* Infants under 1 month with progressive disease eligible
* Supportive care may be given to confirm that the leukemia is not regressing prior to entry
* No acute promyelocytic leukemia (FAB M3)
* No acute undifferentiated leukemia (FAB M0)
* Histochemical verification of AML required by the following stains:
* Wright or Giemsa
* Peroxidase
* PAS
* Chloroacetate esterase
* Sudan black
* Nonspecific esterase (NSE) with and without fluoride (NaF) inhibition
* Combined NSE/NaF and butyrate inhibition or diagnosis of megakaryoblasticleukemia (FAB M7) should be supported by one of the following:
* CD41 reactivity
* Glycoprotein 1b reactivity
* Factor VIII-related antigen reactivity
* Platelet peroxidase on electron microscopy
* The following are also eligible:
* Myelodysplastic syndromes, including:
* Refractory anemia (RA) \*
* RA with ringed sideroblasts (RARS) \*
* RA with excess blasts (RAEB)
* RAEB in transformation (RAEBt)
* Chronic myelomonocytic leukemia (CMML)
* AML with monosomy 7
* Granulocytic sarcoma (chloroma) with or without marrow involvement
* Mixed lineage leukemia with 2 morphologically defined populations provided the predominant population is myeloid
* No Downs syndrome
* No juvenile chronic myelogenous leukemia
* No Fanconi's anemia
* No secondary AML
* Performance status - Not specified
* No prior anticancer chemotherapy
* Prior topical or inhaled steroids for nonmalignant conditions allowed
* No prior anticancer radiotherapy
* No prior antileukemic therapy
* Infants under 1 month with progressive disease eligible
* Supportive care may be given to confirm that the leukemia is not regressing prior to entry
* No acute promyelocytic leukemia (FAB M3)
* No acute undifferentiated leukemia (FAB M0)
* Histochemical verification of AML required by the following stains:
* Wright or Giemsa
* Peroxidase
* PAS
* Chloroacetate esterase
* Sudan black
* Nonspecific esterase (NSE) with and without fluoride (NaF) inhibition
* Combined NSE/NaF and butyrate inhibition or diagnosis of megakaryoblasticleukemia (FAB M7) should be supported by one of the following:
* CD41 reactivity
* Glycoprotein 1b reactivity
* Factor VIII-related antigen reactivity
* Platelet peroxidase on electron microscopy
* The following are also eligible:
* Myelodysplastic syndromes, including:
* Refractory anemia (RA) \*
* RA with ringed sideroblasts (RARS) \*
* RA with excess blasts (RAEB)
* RAEB in transformation (RAEBt)
* Chronic myelomonocytic leukemia (CMML)
* AML with monosomy 7
* Granulocytic sarcoma (chloroma) with or without marrow involvement
* Mixed lineage leukemia with 2 morphologically defined populations provided the predominant population is myeloid
* No Downs syndrome
* No juvenile chronic myelogenous leukemia
* No Fanconi's anemia
* No secondary AML
* Performance status - Not specified
* No prior anticancer chemotherapy
* Prior topical or inhaled steroids for nonmalignant conditions allowed
* No prior anticancer radiotherapy
* No prior antileukemic therapy
Maximum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Beverly Lange
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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Tarlock K, Gerbing RB, Ries RE, Smith JL, Leonti A, Huang BJ, Kirkey D, Robinson L, Peplinski JH, Lange B, Cooper TM, Gamis AS, Kolb EA, Aplenc R, Pollard JA, Alonzo TA, Meshinchi S. Prognostic impact of cooccurring mutations in FLT3-ITD pediatric acute myeloid leukemia. Blood Adv. 2024 May 14;8(9):2094-2103. doi: 10.1182/bloodadvances.2023011980.
Reference Type
DERIVED
Bertrums EJM, Smith JL, Harmon L, Ries RE, Wang YJ, Alonzo TA, Menssen AJ, Chisholm KM, Leonti AR, Tarlock K, Ostronoff F, Pogosova-Agadjanyan EL, Kaspers GJL, Hasle H, Dworzak M, Walter C, Muhlegger N, Morerio C, Pardo L, Hirsch B, Raimondi S, Cooper TM, Aplenc R, Gamis AS, Kolb EA, Farrar JE, Stirewalt D, Ma X, Shaw TI, Furlan SN, Brodersen LE, Loken MR, Van den Heuvel-Eibrink MM, Zwaan CM, Triche TJ, Goemans BF, Meshinchi S. Comprehensive molecular and clinical characterization of NUP98 fusions in pediatric acute myeloid leukemia. Haematologica. 2023 Aug 1;108(8):2044-2058. doi: 10.3324/haematol.2022.281653.
Reference Type
DERIVED
Ho PA, Zeng R, Alonzo TA, Gerbing RB, Miller KL, Pollard JA, Stirewalt DL, Heerema NA, Raimondi SC, Hirsch B, Franklin JL, Lange B, Meshinchi S. Prevalence and prognostic implications of WT1 mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2010 Aug 5;116(5):702-10. doi: 10.1182/blood-2010-02-268953. Epub 2010 Apr 22.
Reference Type
DERIVED
Pollard JA, Alonzo TA, Gerbing RB, Ho PA, Zeng R, Ravindranath Y, Dahl G, Lacayo NJ, Becton D, Chang M, Weinstein HJ, Hirsch B, Raimondi SC, Heerema NA, Woods WG, Lange BJ, Hurwitz C, Arceci RJ, Radich JP, Bernstein ID, Heinrich MC, Meshinchi S. Prevalence and prognostic significance of KIT mutations in pediatric patients with core binding factor AML enrolled on serial pediatric cooperative trials for de novo AML. Blood. 2010 Mar 25;115(12):2372-9. doi: 10.1182/blood-2009-09-241075. Epub 2010 Jan 7.
Reference Type
DERIVED
Ho PA, Alonzo TA, Gerbing RB, Pollard J, Stirewalt DL, Hurwitz C, Heerema NA, Hirsch B, Raimondi SC, Lange B, Franklin JL, Radich JP, Meshinchi S. Prevalence and prognostic implications of CEBPA mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2009 Jun 25;113(26):6558-66. doi: 10.1182/blood-2008-10-184747. Epub 2009 Mar 20.
Reference Type
DERIVED
Other Identifiers
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2961
Identifier Type: -
Identifier Source: secondary_id
CDR0000064883
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-01834
Identifier Type: -
Identifier Source: org_study_id
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Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia
NCT00764907
UNKNOWN
PHASE3
Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
NCT00002658
UNKNOWN
PHASE3
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT00558519
UNKNOWN
PHASE2
Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
NCT00004128
UNKNOWN
PHASE3
Donor Stem Cell Transplant in Treating Patients With High Risk Acute Myeloid Leukemia
NCT01801046
TERMINATED
PHASE1
Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia
NCT00553202
COMPLETED
PHASE2
Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Leukemia
NCT02446964
COMPLETED
PHASE1
Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML
NCT02094794
ACTIVE_NOT_RECRUITING
PHASE2
Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
NCT00003593
COMPLETED
PHASE3
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
NCT00049517
COMPLETED
PHASE3
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT00103285
COMPLETED
PHASE3
Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT01707004
COMPLETED
PHASE2
Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
NCT00002800
COMPLETED
PHASE2
Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
NCT00006363
COMPLETED
PHASE3