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NCT00002812 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia

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
2013-08-26

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.

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
DISEASE CHARACTERISTICS: Acute lymphocytic leukemia (ALL) with M3 bone marrow No FAB L3 morphology CNS or overt testicular leukemia at diagnosis allowed High risk status 10-21 years old with any white blood count (WBC) 1-9 years old with WBC of 50,000/mm3 or greater PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: No prior therapy for ALL except: Emergency therapy for blast crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration Biologic therapy: Not specified Chemotherapy: Intrathecal cytarabine or methotrexate allowed at diagnostic lumbar puncture Induction therapy must begin within 72 hours after intrathecal injection Endocrine therapy: At least 1-2 months since prior prednisone, for less than 48 hours, for reactive airway disease Inhalational steroids allowed Radiotherapy: Not specified Surgery: Not specified
healthy Volunteers
false
maximum Age
21 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow. Consolidation (Phase II) (5 weeks) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: idarubicin
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: pegaspargase
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Arm A - Standard BFM of Standard Duration (RER)
    type
    EXPERIMENTAL
  2. description
    Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (5 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: idarubicin
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: pegaspargase
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Arm B - Standard BFM with Double Delayed Intensification (RER)
    type
    EXPERIMENTAL
  3. description
    Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: idarubicin
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: pegaspargase
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Arm C - Augumented BFM of Standard Duration (RER)
    type
    EXPERIMENTAL
  4. description
    Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: idarubicin
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: pegaspargase
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    asparaginase
    other Names
    1. E. coli
    2. Elspar
    3. NSC-109229
    type
    DRUG
  2. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. Cytoxan
    2. NSC-26271
    type
    DRUG
  3. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    cytarabine
    other Names
    1. Cytosine Arabinoside
    2. Ara-C
    3. Cytosar-U
    4. NSC-63878
    type
    DRUG
  4. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    daunorubicin hydrochloride
    other Names
    1. Daunomycin Hydrochloride
    2. Cerrubidine
    3. NSC-82151
    type
    DRUG
  5. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    dexamethasone
    other Names
    1. Decadron
    2. NSC-34521
    type
    DRUG
  6. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    doxorubicin hydrochloride
    other Names
    1. Adriamycin
    2. NSC-123127
    type
    DRUG
  7. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    idarubicin
    other Names
    1. Idarubicin Hydrochloride
    2. Idamycin
    3. NSC-256439
    type
    DRUG
  8. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    mercaptopurine
    other Names
    1. 6-MP
    2. Purinethol
    3. NSC-755
    type
    DRUG
  9. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given PO
    name
    methotrexate
    other Names
    1. NSC-740
    type
    DRUG
  10. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    pegaspargase
    other Names
    1. Asparaginase
    2. Oncaspar
    type
    DRUG
  11. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given PO
    name
    prednisone
    other Names
    1. NSC-10023
    type
    DRUG
  12. arm Group Labels
    1. Arm A - Standard BFM of Standard Duration (RER)
    2. Arm B - Standard BFM with Double Delayed Intensification (RER)
    3. Arm C - Augumented BFM of Standard Duration (RER)
    4. Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
    description
    Given IV
    name
    thioguanine
    other Names
    1. 6-TG
    2. NSC-752
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2078
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The primary outcome index used in examining most of the randomized treatment groups will be event-free survival (EFS).
    measure
    Event Free Survival
    time Frame
    from the time of randomization where the life table events will consist of the first occurrence of the following events: failure to achieve remission, leukemic relapse at any site, death, or occurrence of a second malignancy.
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
detailed Description
OBJECTIVES: I. Compare the outcomes in children with higher risk acute lymphocytic leukemia (ALL) treated with postinduction chemotherapy based on marrow response on day 7 of induction therapy: for patients with rapid early response (M1/M2), standard vs intensified consolidation chemotherapy and standard vs prolonged duration of intensification chemotherapy; for patients with slow early response, addition of doxorubicin vs idarubicin and cyclophosphamide to intensification chemotherapy. II. Decrease the incidence of avascular necrosis by alternating dexamethasone dosing in patients undergoing 2 courses of delayed intensification. III. Assess the impact of day 7 marrow status on outcome in these patients. IV. Determine prognosis more precisely by supplementing presenting clinical features, immunophenotype, ploidy, cytogenetics, and early marrow response with BAX/BCL-2 ratios, pattern of tyrosine kinase activation, leukemic burden following induction and intensification therapy, and development of high antibody titer to E. coli asparaginase. V. Correlate the traditional prognostic factors of day 7 marrow response, immunophenotype, ploidy, cytogenetics, and early marrow response with BAX/BCL-2 ratios. OUTLINE: This is a partially randomized, multicenter study. Patients are stratified by center. Patients receive one course of the VPLD regimen comprised of vincristine IV and daunorubicin IV over 15 minutes to 2 hours on days 0 and 7, oral prednisone daily on days 0-7, intrathecal cytarabine on day 0, and asparaginase or pegaspargase intramuscularly on days 3, 5, and 7. Patients are assigned to 1 of 2 two postinduction chemotherapy groups based on bone marrow response on day 7 of induction. Patients with M1/M2 marrow on day 7 are considered rapid early responders. Patients with M3 marrow on day 7 are considered slow early responders. Group 1: Rapid early responders Patients receive 2 additional courses of VPLD induction chemotherapy. Patients are then randomized to 1 of 4 treatment arms: Arm I: Beginning on day 35 of induction therapy, patients receive standard Berlin-Frankfurt-Munster (BFM) regimen with standard delayed intensification. Standard BFM for patients in arm I consists of the following: consolidation over 5 weeks with cyclophosphamide, cytarabine, and mercaptopurine; interim maintenance over 8 weeks with oral methotrexate and mercaptopurine (MTX/MP); and delayed intensification over 7 weeks consisting of reinduction with vincristine, doxorubicin, oral dexamethasone, and asparaginase or pegaspargase followed by reconsolidation with cyclophosphamide, thioguanine, and cytarabine. Arm II: Patients receive standard BFM regimen with double delayed intensification. Patients receive therapy similar to those in arm I, but dexamethasone is interrupted for 1 week during delayed intensification and the intensification regimen is repeated, separated by an 8 week interim maintenance course of oral MTX/MP. Arm III: Patients receive augmented BFM regimen with standard delayed intensification. Patients receive 9 weeks of consolidation therapy with 2 courses of vincristine and pegaspargase alternating with the arm I consolidation therapy. Vincristine, intravenous methotrexate, and pegaspargase (the Capizzi I regimen) are substituted for oral MTX/MP in the interim maintenance regimen. Pegaspargase is substituted for asparaginase and two additional doses of vincristine are administered during delayed intensification. Arm IV: Patients receive augmented BFM regimen with double delayed intensification. Patients receive intensified chemotherapy throughout, combining the additional therapy given to patients in arms II and III. Patients receiving augmented BFM regimen receive pegaspargase instead of asparaginase. Patients with CNS disease at diagnosis are treated only on arm IV. Patients who are Philadelphia chromosome positive and do not have a bone marrow donor are nonrandomly assigned to the treatment group for slow early responders. All RER patients receive the same maintenance therapy with vincristine/prednisone and oral MTX/MP. Intrathecal methotrexate is administered periodically throughout protocol treatment. Group 2: Slow early responders Patients receive augmented BFM consolidation therapy and Capizzi I interim maintenance identical to that received by rapid early responders in arm IV. Patients are then randomized to receive double delayed intensification with either idarubicin or doxorubicin and concurrent cyclophosphamide. All patients receive the same maintenance therapy with vincristine/prednisone and oral MTX/MP. Intrathecal MTX is administered periodically throughout protocol treatment. Patients with CNS disease at entry receive craniospinal irradiation daily for 5 consecutive days beginning on day 0 of consolidation therapy. All slow early responders at diagnosis receive cranial irradiation daily for 5 consecutive days during consolidation therapy. Patients with testicular leukemia at diagnosis receive bilateral testicular irradiation daily for 5 consecutive days during consolidation chemotherapy. Groups 1 and 2: Maintenance therapy continues for 2 years for girls or 3 years for boys beyond completion of consolidation therapy. Patients are followed every 4-6 weeks for 1 year, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 1,520 patients will be accrued for this study over 4 years.
Source references
references
  1. citation
    Nguyen K, Devidas M, Cheng SC, La M, Raetz EA, Carroll WL, Winick NJ, Hunger SP, Gaynon PS, Loh ML; Children's Oncology Group. Factors influencing survival after relapse from acute lymphoblastic leukemia: a Children's Oncology Group study. Leukemia. 2008 Dec;22(12):2142-50. doi: 10.1038/leu.2008.251. Epub 2008 Sep 25.
    pmid
    18818707
    type
    BACKGROUND
  2. citation
    Butturini AM, Dorey FJ, Lange BJ, Henry DW, Gaynon PS, Fu C, Franklin J, Siegel SE, Seibel NL, Rogers PC, Sather H, Trigg M, Bleyer WA, Carroll WL. Obesity and outcome in pediatric acute lymphoblastic leukemia. J Clin Oncol. 2007 May 20;25(15):2063-9. doi: 10.1200/JCO.2006.07.7792.
    pmid
    17513811
    type
    BACKGROUND
  3. citation
    Avramis VI, Panosyan EH. Pharmacokinetic/pharmacodynamic relationships of asparaginase formulations: the past, the present and recommendations for the future. Clin Pharmacokinet. 2005;44(4):367-93. doi: 10.2165/00003088-200544040-00003.
    pmid
    15828851
    type
    BACKGROUND
  4. citation
    Seibel NL, Asselin BL, Nachman JB, et al.: Treatment of high risk T-cell acute lymphoblastic leukemia (T-ALL): comparison of recent experience of the Children's Cancer Group (CCG) and Pediatric Oncology Group (POG). [Abstract] Blood 104 (11): A-681, 2004.
    type
    BACKGROUND
  5. citation
    Arce FJ, Seibel N, Gaynon PS, et al.: Pharmacokinetics and pharmacodynamics of asparaginases in antibody-negative pediatric patients with higher risk acute lymphoblastic leukemia (ALL): a report from CCG-1961. [Abstract] J Clin Oncol 24 (Suppl 18): A-9027, 508s, 2006.
    type
    RESULT
  6. citation
    Avramis VI, Ettinger L, Martin-Aragon S, et al.: Anti-asparaginase (ASNase) antibody (Ab) in pediatric patients in high risk ALL study (CCG-1961): correlation of Ab and clinical allergy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2319, 2000.
    type
    RESULT
  7. citation
    Avramis VI, Panosyan E, Avramis IA, et al.: Anti-asparaginase (ASNase) antibody (Ab) and ASNase activity in children with higher risk acute lymphoblastic leukemia (HR ALL) (CCG-1961). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1592, 2002.
    type
    RESULT
  8. citation
    Bhojwani D, Kang H, Menezes RX, Yang W, Sather H, Moskowitz NP, Min DJ, Potter JW, Harvey R, Hunger SP, Seibel N, Raetz EA, Pieters R, Horstmann MA, Relling MV, den Boer ML, Willman CL, Carroll WL; Children's Oncology Group Study; Dutch Childhood Oncology Group; German Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia. Gene expression signatures predictive of early response and outcome in high-risk childhood acute lymphoblastic leukemia: A Children's Oncology Group Study [corrected]. J Clin Oncol. 2008 Sep 20;26(27):4376-84. doi: 10.1200/JCO.2007.14.4519.
    pmid
    18802149
    type
    RESULT
  9. citation
    Dhall G, Jones T, Radvinsky D, et al.: Adverse reactions to PEG and Erwinia asparaginase and correlation with anti-asparaginase antibody data and survival in children with acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group study CCG 1961. [Abstract] Blood 114 (22): A-3077, 2009.
    type
    RESULT
  10. citation
    Dhall G, Robison NJ, Rubin JI, et al.: Incidence of adverse reactions to post-induction asparaginase (ASP) therapy in children and adolescents with high-risk acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group Study CCG-1961. [Abstract] J Clin Oncol 26 (Suppl 15): A-10021, 2008.
    type
    RESULT
  11. citation
    Freyer DR, Devidas M, La M, Carroll WL, Gaynon PS, Hunger SP, Seibel NL. Postrelapse survival in childhood acute lymphoblastic leukemia is independent of initial treatment intensity: a report from the Children's Oncology Group. Blood. 2011 Mar 17;117(11):3010-5. doi: 10.1182/blood-2010-07-294678. Epub 2010 Dec 30.
    pmid
    21193696
    type
    RESULT
  12. citation
    Freyer DR, Seibel NL, La MK, et al.: Survival after relapse in higher risk acute lymphoblastic leukemia (ALL) in children and adolescents is independent of prior treatment intensity: a report from the Children's Oncology Group (COG). [Abstract] Blood 112 (11): A-917, 2008.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        OG reported on the impact of obesity on outcome in 2,008 children, 14% of whom were obese, who were enrolled on a high-risk ALL trial (<a href="/clinicaltrials/NCT00002812">CCG-1961 [NCT00002812]</a>).[<a href="#cit/section_4.103">103</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810033&amp;version=HealthProfessional&amp;lan
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        ct of obesity on outcome in 2,008 children, 14% of whom were obese, who were enrolled on a high-risk ALL trial (<a href="/clinicaltrials/NCT00002812">CCG-1961 [NCT00002812]</a>).[<a href="#cit/section_4.103">103</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810033&amp;version=HealthProfessional&amp;language=English" onclick=
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        ificantly improved outcome for patients with a poor response to a prednisone prophase.[<a href="#cit/section_7.83">83</a>]</li><li>The <a href="/clinicaltrials/NCT00002812">CCG-1961</a> study used a 2 &#215; 2 factorial design to compare both standard- versus augmented-intensity therapies and therapies of standard duration (one i
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        n with T-ALL met National Cancer Institute (NCI) high-risk criteria.<div class="pdq-content-list"><ul id="_1181"><li>Results from the <a href="/clinicaltrials/NCT00002812">CCG-1961</a> trial for high-risk ALL, which included patients with T-ALL, showed that an augmented Berlin-Frankfurt-M&#252;nster (BFM) regimen with a single d
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        <p id="_1579" tabindex="-1">Evidence (osteonecrosis):</p> <div class="pdq-content-list"><ol id="_1580"><li>In the <a href="/clinicaltrials/NCT00002812">CCG-1961</a> high-risk ALL study, alternate-week dosing of dexamethasone was compared with standard continuous dexamethasone during delayed intensification to
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      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice