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NCT00002798 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-01-16

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
21 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Drug: daunorubicin hydrochloride
    2. Drug: therapeutic hydrocortisone
    3. Procedure: allogeneic bone marrow transplantation
    4. Biological: filgrastim
    5. Drug: cytarabine
    6. Drug: idarubicin
    7. Drug: dexamethasone
    8. Drug: thioguanine
    9. Drug: etoposide
    10. Drug: methotrexate
    label
    Arm I (combination chemotherapy)
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Drug: asparaginase
    2. Drug: fludarabine phosphate
    3. Drug: therapeutic hydrocortisone
    4. Procedure: allogeneic bone marrow transplantation
    5. Biological: filgrastim
    6. Drug: cytarabine
    7. Drug: idarubicin
    8. Drug: thioguanine
    9. Drug: methotrexate
    10. Drug: cyclophosphamide
    11. Drug: busulfan
    label
    Arm II (combination chemotherapy)
    type
    EXPERIMENTAL
  3. description
    Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
    intervention Names
    1. Drug: daunorubicin hydrochloride
    2. Biological: filgrastim
    3. Drug: cytarabine
    4. Drug: idarubicin
    5. Drug: dexamethasone
    6. Drug: thioguanine
    7. Drug: etoposide
    8. Biological: aldesleukin
    label
    Arm III (combination chemotherapy, aldesleukin)
    type
    EXPERIMENTAL
  4. description
    No further treatment
    intervention Names
    1. Drug: daunorubicin hydrochloride
    2. Biological: filgrastim
    3. Drug: cytarabine
    4. Drug: idarubicin
    5. Drug: dexamethasone
    6. Drug: thioguanine
    7. Drug: etoposide
    label
    Arm IV (combination chemotherapy)
    type
    ACTIVE_COMPARATOR
  5. description
    Patients undergo radiotherapy to the chloroma 5 days a week for 2 weeks.
    intervention Names
    1. Drug: daunorubicin hydrochloride
    2. Radiation: 3-dimensional conformal radiation therapy
    3. Biological: filgrastim
    4. Drug: cytarabine
    5. Drug: idarubicin
    6. Drug: dexamethasone
    7. Drug: thioguanine
    8. Drug: etoposide
    label
    Arm V (combination chemotherapy, radiotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (combination chemotherapy)
    name
    asparaginase
    other Names
    1. ASNase
    2. Colaspase
    3. Crasnitin
    4. Elspar
    5. L-ASP
    type
    DRUG
  2. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm III (combination chemotherapy, aldesleukin)
    3. Arm IV (combination chemotherapy)
    4. Arm V (combination chemotherapy, radiotherapy)
    name
    daunorubicin hydrochloride
    other Names
    1. Cerubidin
    2. Cerubidine
    3. daunomycin hydrochloride
    4. daunorubicin
    5. RP-13057
    type
    DRUG
  3. arm Group Labels
    1. Arm II (combination chemotherapy)
    name
    fludarabine phosphate
    other Names
    1. 2-F-ara-AMP
    2. Beneflur
    3. Fludara
    type
    DRUG
  4. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm II (combination chemotherapy)
    name
    therapeutic hydrocortisone
    other Names
    1. Aeroseb-HC
    2. Barseb HC
    3. Cetacort
    4. Cort-Dome
    5. Cortef
    type
    DRUG
  5. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm II (combination chemotherapy)
    name
    allogeneic bone marrow transplantation
    other Names
    1. bone marrow therapy, allogeneic
    2. bone marrow therapy, allogenic
    3. transplantation, allogeneic bone marrow
    4. transplantation, allogenic bone marrow
    type
    PROCEDURE
  6. arm Group Labels
    1. Arm V (combination chemotherapy, radiotherapy)
    name
    3-dimensional conformal radiation therapy
    other Names
    1. 3D conformal radiation therapy
    2. 3D-CRT
    type
    RADIATION
  7. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm II (combination chemotherapy)
    3. Arm III (combination chemotherapy, aldesleukin)
    4. Arm IV (combination chemotherapy)
    5. Arm V (combination chemotherapy, radiotherapy)
    description
    Given SC
    name
    filgrastim
    other Names
    1. G-CSF
    2. Neupogen
    type
    BIOLOGICAL
  8. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm II (combination chemotherapy)
    3. Arm III (combination chemotherapy, aldesleukin)
    4. Arm IV (combination chemotherapy)
    5. Arm V (combination chemotherapy, radiotherapy)
    description
    Given IV or IT
    name
    cytarabine
    other Names
    1. ARA-C
    2. arabinofuranosylcytosine
    3. arabinosylcytosine
    4. Cytosar-U
    5. cytosine arabinoside
    type
    DRUG
  9. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm II (combination chemotherapy)
    3. Arm III (combination chemotherapy, aldesleukin)
    4. Arm IV (combination chemotherapy)
    5. Arm V (combination chemotherapy, radiotherapy)
    description
    Given IV
    name
    idarubicin
    other Names
    1. 4-demethoxydaunorubicin
    2. 4-DMDR
    3. DMDR
    4. IDA
    type
    DRUG
  10. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm III (combination chemotherapy, aldesleukin)
    3. Arm IV (combination chemotherapy)
    4. Arm V (combination chemotherapy, radiotherapy)
    description
    Given PO
    name
    dexamethasone
    other Names
    1. Aeroseb-Dex
    2. Decaderm
    3. Decadron
    4. DM
    5. DXM
    type
    DRUG
  11. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm II (combination chemotherapy)
    3. Arm III (combination chemotherapy, aldesleukin)
    4. Arm IV (combination chemotherapy)
    5. Arm V (combination chemotherapy, radiotherapy)
    description
    Given PO
    name
    thioguanine
    other Names
    1. 6-TG
    type
    DRUG
  12. arm Group Labels
    1. Arm I (combination chemotherapy)
    2. Arm III (combination chemotherapy, aldesleukin)
    3. Arm IV (combination chemotherapy)
    4. Arm V (combination chemotherapy, radiotherapy)
    description
    Given IV
    name
    etoposide
    other Names
    1. EPEG
    2. VP-16
    3. VP-16-213
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
880
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Proportions of patients achieving remission rate during induction therapy
    time Frame
    Up to 42 days
  2. measure
    Proportion of patients dying or with residual disease during induction therapy
    time Frame
    Up to 42 days
  3. measure
    Time to marrow recovery (induction phase)
    time Frame
    Up to 42 days
  4. measure
    Frequency of toxicities, including infectious complications (induction phase)
    time Frame
    Up to 42 days
  5. measure
    Marrow status
    time Frame
    At 14 days
  6. measure
    Percent of blasts
    time Frame
    At the end of induction therapy
  7. measure
    Complete remission at the end of consolidation therapy
    time Frame
    Up to 5 years
  8. measure
    Survival following consolidation
    time Frame
    Up to 5 years
  9. measure
    Event-free survival following consolidation
    time Frame
    Up to 5 years
  10. measure
    Overall survival (intensification)
    time Frame
    Up to 5 years
  11. measure
    EFS (intensification)
    time Frame
    Up to 5 years
Full study description
brief Summary
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
detailed Description
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.
Source references
references
  1. citation
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    pmid
    20056794
    type
    DERIVED
  6. citation
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    pmid
    19304957
    type
    DERIVED
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        ef="#cit/section_4.35">35</a>]</p></li><li><strong>Race and ethnicity:</strong> In both the Children's Cancer Group (CCG) CCG-2891 and <a href="/clinicaltrials/NCT00002798">COG-2961 (NCT00002798)</a> studies, White children had higher OS rates than Black and Hispanic children.[<a href="#cit/section_4.24">24</a>,<a href="#cit/sect
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        35</a>]</p></li><li><strong>Race and ethnicity:</strong> In both the Children's Cancer Group (CCG) CCG-2891 and <a href="/clinicaltrials/NCT00002798">COG-2961 (NCT00002798)</a> studies, White children had higher OS rates than Black and Hispanic children.[<a href="#cit/section_4.24">24</a>,<a href="#cit/section_4.36">36</a>,<a hre
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        unt) recovery has been used to reduce treatment-related mortality.</p> <div class="pdq-content-list"><ul id="_2144"><li> The <a href="/clinicaltrials/NCT00002798">COG-2961 (NCT00002798)</a> trial demonstrated the following:[<a href="#cit/section_6.7">7</a>]<div class="pdq-content-list"><ul id="_2145"><li>A significant r
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        used to reduce treatment-related mortality.</p> <div class="pdq-content-list"><ul id="_2144"><li> The <a href="/clinicaltrials/NCT00002798">COG-2961 (NCT00002798)</a> trial demonstrated the following:[<a href="#cit/section_6.7">7</a>]<div class="pdq-content-list"><ul id="_2145"><li>A significant reduction in treatment-r
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        te-risk AML):</p> <div class="pdq-content-list"><ol id="_956"><li>A study combining the results of the POG-8821, CCG-2891, <a href="/clinicaltrials/NCT00002798">COG-2961 (NCT00002798)</a>, and MRC AML10 studies reported the following:[<a href="#cit/section_6.65">65</a>] <div class="pdq-content-list"><ul id="_2152"><li
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        <div class="pdq-content-list"><ol id="_956"><li>A study combining the results of the POG-8821, CCG-2891, <a href="/clinicaltrials/NCT00002798">COG-2961 (NCT00002798)</a>, and MRC AML10 studies reported the following:[<a href="#cit/section_6.65">65</a>] <div class="pdq-content-list"><ul id="_2152"><li>A DFS and OS advantage
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      1. context
        Updated: April 15, 2025
        datetime
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        display
        April 15, 2025

    Preserved source evidence · Not medical advice