Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Related Clinical Trial
Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL) A Study Of Inotuzumab Ozogamicin Versus Investigator’s Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia Effect of Vitamin D Diffiency on Oral Mucosa in Patients Recieving Methotrexate Chemotherapy Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia: A Study of Children With Refractory or Relapsed ALL Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International Pharmacogenetically Based Dosing of Thiopurines in Childhood Acute Lymphoblastic Leukemia ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL) Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia Phase II Front-line Ponatinib in Adult Philadelphia+/BCR-ABL+ Acute Lymphoblastic Leukemia. Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL) Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL) Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL) Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL) A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients Rapamycin in Relapsed Acute Lymphoblastic Leukemia Treatment of Childhood Acute Lymphoblastic Leukemia Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia CD19-CAR Immunotherapy for Childhood Acute Lymphoblastic Leukemia (ALL) Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL) Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC) Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia Pharmacokinetic Profile of Vincristine Administered With Imatinib for Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) Compared to That Without Imatinib for Bcr-Abl Negative ALL Phase III B in Acute Lymphoblastic Leukemia The Effects of Honey on Febrile Neutropenia in Children With Acute Lymphoblastic Leukemia Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia Treatment of Acute Lymphoblastic Leukemia in Children PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents Treatment of High Risk Adult Acute Lymphoblastic Leukemia Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Acute Lymphoblastic Leukemia (B-ALL) Medical Research Council (MRC) Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003 A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL) The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I Study of Sirolimus With PEG-Asparaginase in Acute Lymphoblastic Leukemia (ALL) Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph ‘Negative in Elderly Patients (> 55 Years) Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008 A Study Evaluating KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia Treatment of Older Adults With Acute Lymphoblastic Leukemia Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+ CTA101 UCAR-T Cell Injection for Treatment of Relapsed or Refractory CD19+ B-cell Acute Lymphoblastic Leukemia Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) Osteonecrosis in Children With Acute Lymphoblastic Leukemia Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL) Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL) STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia A Study in Adults With Untreated Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Relapse in Sweden 2003-2007 The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop Cancer Care Delivery in Adolescent and Young Adult Patients With Acute Lymphoblastic Leukemia Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients Metformin Reduce the Relapse Rate on Patients With B-cell Precursor (Ph+ Negative) Acute Lymphoblastic Leukemia Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals Genomic Changes in Childhood Acute Lymphoblastic Leukemia Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children. Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL) Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia New Markers for Minimal Residual Disease in Acute Lymphoblastic Leukemia Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia FoxO3a and PU.1 in Acute Lymphoblastic Leukemia Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia Genome-wide Single Nucleotide Polymorphism (SNP) Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Lymphoblastic Leukemia Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)

Brief Title

Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Official Title

Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Brief Summary

      The main purpose of this study is to find out if radiation to the central nervous system
      (CNS) can be safely omitted with early intensification of chemotherapy and chemotherapy given
      directly to the CNS. Another purpose is to find out if survival of children with ALL can be
      improved with risk-directed therapy given on this protocol.
    

Detailed Description

      There are multiple secondary objectives in this trial:

        -  To estimate the overall event-free survival of patients treated with risk-directed
           therapy

        -  To identify the plasma methotrexate (MTX) concentrations that produce maximum
           intracellular accumulation of active metabolites (methotrexate polyglutamates, MTXPG) in
           vivo, in relation to major cell lineage and genotype

        -  To determine the relation between MTXPG accumulation in leukemic lymphoblasts and
           antileukemic effects, as measured by the inhibition of de novo purine synthesis, and by
           the decrease in circulating blasts during the 4 days after initiation of single-agent
           high-dose methotrexate treatment

        -  To determine if plasma MTX concentrations exceeding those required for maximum MTXPG
           accumulation cause a paradoxical decrease in the accumulation of long-chain MTXPG in
           lymphoblasts, (e.g., due to "feedback inhibition" of folypolyglutamate synthetase)

        -  To determine if there are significant differences in lymphoblast uptake of MTX and
           expression of the reduced folate carrier in T-lineage vs B-lineage lymphoblasts, and in
           hyperdiploid vs non-hyperdiploid B-lineage lymphoblasts

        -  To investigate whether atovaquone (ATQ) is as effective as trimethoprim-sulfamethoxazole
           (TMP-SMZ) in preventing Pneumocystis carinii pneumonitis (PCP)

        -  To investigate whether or not the administration of G-CSF at the onset of febrile
           episodes in neutropenia patients after induction or any of the two reinductions will
           affect the extent and duration of fever.

        -  To determine whether levels of minimal residual disease in peripheral blood (PB) reflect
           those measured in the bone marrow (BM) by immunologic or molecular techniques

        -  To assess the degree of DNA damage in somatic cells (leukocytes) during treatment

        -  To explore whether genetic polymorphisms of enzymes important in metabolism of
           antileukemic agents (e.g. methylene tetrahydrofolate reductase, thiopurine
           methyltransferase, glutathione transferases) are correlated with MTX pharmacology in
           lymphoblasts, acute toxicities and long-term outcome

        -  To explore whether the development of anti-asparaginase antibodies or CSF depletion of
           asparaginase is correlated with acute toxicities and long-term outcome

        -  To assess the relation between MRI changes of brain (especially white matter
           abnormalities) from HDMTX and intrathecal treatment, neurologic and cognitive deficits,
           CSF levels of homocysteines and diminished quality of life

        -  To investigate whether early MRI changes are related to late MRI abnormalities,
           neurologic and cognitive deficits, and diminished quality of life

        -  To correlate changes in MRI, neurologic or cognitive deficits and diminished quality of
           life with selected pharmacokinetic variables

        -  To determine the prevalence of low bone density and to correlate this complication with
           potential risk factors

      Details of Treatment Interventions:

      Treatment will consist of three main phases, Remission Induction (including an Upfront HDMTX
      Window), Consolidation, and Continuation.

      Window Therapy Upfront HDMTX is considered the first part of remission induction treatment.
      HDMTX will be given by vein over 24 hours (one day). MTX 500 mg/m2 for standard risk and 250
      mg/m2 for low-risk cases will be given over 1 hour, followed immediately by maintenance
      infusion (4500 mg/m2 for standard/high-risk or 2250 mg/m2 for low-risk cases) over 23 hours.

      Remission Induction Therapy (6-7 weeks) The remaining induction treatment will begin with
      Prednisone 40 mg/m2/day PO (tid) Days 5-32, Vincristine 1.5 mg/m2/week IV days 5, 12, 19, 26,
      Daunorubicin 25 mg/m2/week IV days 5, 12, L-asparaginase 10,000 U/m2/dose IM (thrice weekly)
      days 6, 8, 10, 12, 14, 16 (19, 21, 23), and triple intrathecal treatment, followed by
      Etoposide 300 mg/m2/dose IV over 2 hr days 26, 29, 33, plus Cytarabine 300 mg/m2/dose IV over
      2 hr Days 26, 29, 33.

      Triple intrathecal chemotherapy (MHA) is used for the remaining treatment with dosages based
      on age Frequency and total number of triple intrathecal treatment for Remission Induction are
      based on the patient's risk of CNS relapse.

      Consolidation (2 weeks) Patients receive High dose Methotrexate (HDMTX) 2.5 gm/m2 (low-risk)
      or 5 gm/m2 (standard-or-high-risk) IV over 24 hr days 1 and 8 and 6-Mercaptopurine 25
      mg/m2/day PO days 1 to 14. All patients will receive triple intrathecal therapy weekly for
      two doses on Days 1 and 8.

      Continuation treatment (120 weeks for girls and 146 weeks for boys) Post-remission
      continuation treatment begins 7 days after the second course of HDMTX of the consolidation
      treatment, provided that the ANC ≥300/mm3 and platelet count ≥ 50 x 109/L. Continuation
      treatment will be 120 weeks for girls and 146 weeks for boys and differs according to the
      risk classification.

      Reinduction Treatment This phase of treatment will be started at weeks 12 and 28 after bone
      marrow examination confirms complete remission.

      Reinduction treatment will be given twice:

      Weeks 12 to 16 and week 28 to 32 for standard/high risk cases; weeks 12 to 15 and weeks 28-31
      for low-risk cases. Leucovorin rescue (5 mg/m2) will be given at 24 and 30 hours after the
      intrathecal treatment during both remission reinduction treatments. No chemotherapy will be
      given weeks 16 and 32 for standard/high risk patients.

      Standard- or High-Risk Leukemia

        -  DEX (dexamethasone) 8 mg/m2 PO daily (tid) x 7 days and VCR (vincristine) 1.5 mg/m2 IV
           push (max. 2 mg) will be given weeks 1, 5, 9, 17, 21, 25, 33, 37, 41, 45, 49, 53, 57,
           61, 65, 69, 73, 77, 81, 85, 89, 93, 97, 101, 105, 109, 113, and 117.

        -  VP16 (etoposide) 300 mg/m2 IV over 2 hours and CTX (cyclophosphamide) 300 mg/m2 IV short
           infusion will be given weeks 2, 6, 10, 18, 22, 26, 34, 38, 42, 46, 50, 54, 58, 62, 66,
           70, 74, 78, 82, 86, 90, and 94.

        -  6MP (6-mercaptopurine) 75 mg/m2 PO daily x 7 days and MTX (methotrexate) 40 mg/m2 IV or
           IM weeks 3, 8, 11, 19, 24, 27, 35, 39, 40, 43, 47, 48, 51, 55, 56, 59, 63, 64, 67, 71,
           72, 75, 79, 80, 83, 87, 88, 91, 95, 96, 98, 99, 102, 103, 104, 106, 107, 110, 111, 112,
           114, 115, 118, 119, and 120, and weeks 121-146 for boys.

        -  MTX (methotrexate) 40 mg/m2 IV or IM and Ara-C (cytarabine) 300 mg/m2 IV push will be
           given weeks4, 20, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, and 116.

        -  6MP (6-mercaptopurine) 75 mg/m2 PO daily x 7 days and HDMTX 5 gm/ gm/m2 will be given
           week 7 and 23.

        -  HDMTX 5 gm/ gm/m2 and Ara-C (cytarabine) 300 mg/m2 IV push will be given weeks 15 and
           31.

      Reinduction Treatment-Standard/High Risk

        -  DEX (dexamethasone) 8 mg/m2 PO daily (tid) days 1-21,

        -  VCR (vincristine) 1.5 mg/m2/week IV (max. 2 mg) days 1, 8, and 15

        -  PEG-asparaginase 2500 U/m2/week IM weeks 28-31, days 8, and 15

        -  Idarubicin 5 mg/m2/week IV days 1 and 8

        -  HDMTX 5 gm/m2 IV day 22

        -  ITMHA (methotrexate+hydrocortisone+ara-C), age dependent, IT day 1

        -  High-dose cytarabine 2 gm/m2 IV q 12 hr Days 23, and 24 Low Risk

        -  6MP (6-mercaptopurine) 75 mg/m2 PO daily x 7 days and MTX (methotrexate) 40 mg/m2 IV or
           IM weeks 1, 2, 3, 4, 6, 8, 10,, 11, 16, 18- 20, 22, 24, 26, 27, 32, 34- 36, 38-40, 42-
           44, 46-48, 50-52, 54-56, 58-60, 62-64, 66-68, 70-72, 74-76, 78-80, 82-84, 86-88, 90-92,
           94-96, 98-100, 102-104, 106-108, 110-112, 114-116, 118-120 and weeks 121-146 for boys.

        -  6MP (6-mercaptopurine) 75 mg/m2 PO daily x 7 days, MTX (methotrexate) 40 mg/m2 IV or IM,
           DEX (dexamethasone) 8 mg/m2 PO daily (tid) x 7 days and VCR (vincristine) 1.5 mg/m2 IV
           push (max. 2 mg) weeks 5, 9, 17, 21, 25, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77,
           81, 85, 89, 93, 97, 101, 105, 109, 113, and 117.

        -  6MP (6-mercaptopurine) 75 mg/m2 PO daily x 7 days and HDMTX 2.5 gm/m2 weeks 7, 15, 23
           and 31.

      Reinduction Treatment-Low Risk

        -  DEX (dexamethasone) 8 mg/m2 PO daily days 1-21,

        -  VCR (vincristine) 1.5 mg/m2/week IV push (max. 2 mg) days 1, 8, and 15

        -  PEG-asparaginase 2500 U/m2/week IM days 8, and 15

        -  Idarubicin 5 mg/m2/week IV day 1

        -  HDMTX 2.5 gm/m2 day 22

        -  ITMHA (methotrexate+hydrocortisone+ara-C), age dependent, IT day 1 and 22

        -  6 MP 75 mg/m2/day PO days 22-28 IT Chemotherapy

        -  Triple intrathecal treatment will be given to low-risk cases with CNS-1 status on weeks
           1, 2, 7, 12, 15, 23, 28, 31, 39, 47, and 54.

        -  Triple intrathecal treatment will be given to low-risk cases with CNS-2 or traumatic CSF
           status on weeks 1, 2, 7, 12, 15, 19, 23, 28, 31, 36, 39, 43, 47, and 54.

        -  Triple intrathecal treatment will be given to standard/high-risk cases on weeks 1, 2, 7,
           12, 19, 23, 28, 36, 39, 43, 47, and 54.

        -  Triple intrathecal treatment will be given to other standard/high-risk cases with WBC
           ≥100 x 109/L, T-cell ALL with WBC ≥50 x 109/L, presence of Philadelphia chromosome, MLL
           rearrangement, near haploidy, or CNS-3 status on weeks 1, 2, 7, 12, 19, 23, 28, 36, 39,
           43, 47, 54, 64, 72, 80, and 88.

      Hematopoietic Stem Cell Transplantation Patients who meet the criteria of high-risk ALL will
      be offered the option of transplantation with a matched, related or unrelated donor. However,
      if the option is declined or if a suitable donor is not available, the patient will remain on
      study and continue to receive chemotherapy.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

To determine if CNS irradiation can be safely omitted with early intensification of systemic and intrathecal chemotherapy.


Condition

Acute Lymphoblastic Leukemia

Intervention

Prednisone, Dexamethasone, Vincristine, Daunorubicin, PEG-L-asparaginase

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

53

Start Date

July 1998

Completion Date

July 2002

Primary Completion Date

July 2002

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of non-B-cell leukemia by immunophenotyping (e.g. T-cell, B-cell precursor,
             or acute undifferentiated leukemia)

          -  Ages less than or equal to 18 years of age

          -  One week or less of prior therapy, limited to glucocorticoids, vinca alkaloids,
             emergency radiation therapy to the mediastinum and one dose of intrathecal
             chemotherapy Exclusion Criteria

          -  Participants greater than 18 years of age
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Ching-Hon Pui, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00187005

Organization ID

TOTXIV



Study Sponsor

St. Jude Children's Research Hospital


Study Sponsor

Ching-Hon Pui, MD, Principal Investigator, St. Jude Children's Research Hospital


Verification Date

June 2008