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Trial record 89 of 170 for:    "Acute Lymphocytic Leukemia" | "Etoposide"

SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002665
Recruitment Status : Completed
First Posted : July 29, 2004
Last Update Posted : March 6, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without bone marrow transplantation in treating patients who have acute lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Neutropenia Thrombocytopenia Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy Phase 2

Detailed Description:

OBJECTIVES: I. Evaluate if front line induction therapy with daunorubicin, vincristine, prednisone, and asparaginase is sufficiently effective to warrant a phase III trial in patients with acute lymphocytic leukemia (ALL). II. Assess the toxicity of this regimen in this patient population. III. Assess disease free and overall survival and toxicity associated with allogeneic bone marrow transplantation for ALL patients in first remission following induction and consolidation therapy. IV. Assess disease free and overall survival and toxicity associated with sequential regimens of mercaptopurine, methotrexate and vincristine, doxorubicin, dexamethasone, and cyclophosphamide, thioguanine, and cytarabine in ALL patients in first remission who are ineligible for allogeneic bone marrow transplantation. V. Evaluate the prognostic significance of cell surface immunophenotype, Philadelphia chromosome, and polymerase chain reaction detected BCR/abl fusion in this patient population.

OUTLINE: Patients are stratified according to age (15 to 29 vs 30 to 49 vs 50 to 65), performance status (0-1 vs 2-3), participating center, and candidate for allogeneic bone marrow transplantation (yes vs no). Patients receive induction chemotherapy consisting of daunorubicin IV on days 1-3, vincristine IV on days 1, 8, 15, and 22, oral prednisone on days 1-28, and asparaginase IV or intramuscularly (IM) on days 15-24. Patients with persistent leukemia on day 21, receive additional induction therapy consisting of daunorubicin IV on days 22 and 23, vincristine IV on days 29 and 36, and oral prednisone continuing to day 42. Patients with CNS leukemia receive additional therapy beginning on day 1 of induction chemotherapy consisting of methotrexate intrathecally (IT) or intraventricularly twice weekly until blasts are absent in spinal fluid. Patients receive oral leucovorin calcium every 6 hours for a total of 4 doses following each IT dose in the absence of blood count recovery. Following absence of spinal fluid blasts, patients receive methotrexate IT or intraventricularly weekly for 4 weeks then monthly for 1 year. Patients also receive cranial radiotherapy during consolidation therapy 5 days a week for 2.5 weeks. Patients with A1 bone marrow receive consolidation therapy following completion of induction therapy and blood count recovery. Patients receive consolidation therapy consisting of cyclophosphamide IV on days 1, 15, and 29, cytarabine IV on days 2-5, 9-12, 16-19, and 23-26, oral mercaptopurine on days 1-28, and methotrexate IT on days 2, 9, 16, and 23. Following completion of consolidation therapy, patients eligible for allogeneic bone marrow transplantation receive total body radiotherapy 3 times a day on days -7, -6, -5, and twice on day -4, and eptoposide IV over 4 hours on day -3. Patients undergo allogeneic bone marrow transplantation on day 0. Following completion of consolidation therapy, patients ineligible for allogeneic bone marrow transplantation receive maintenance therapy consisting of oral mercaptopurine on days 1-63, and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients receive subsequent courses of maintenance therapy when blood counts recover. Patients receive a second course of maintenance therapy consisting of vincristine IV on days 1, 8, 15, and 22, doxorubicin IV on days 1, 8, 15, and 22, and oral dexamethasone on days 1-28. Patients receive a third course consisting of cyclophosphamide IV on day 1, oral thioguanine on days 1-14, and cytarabine IV on days 3-6 and 10-13. Patients receive a fourth course consisting of oral mercaptopurine and oral methotrexate daily for 2 years. Patients are followed monthly for 6 months and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 1995
Actual Primary Completion Date : December 2001
Actual Study Completion Date : December 2003

Intervention Details:
  • Drug: asparaginase
    10,000 units/d IV or IM 15 - 24
  • Drug: cyclophosphamide
    con: 650 mg/m2 IV 1, 15, 29 maint: 650 mg/m2 IV 1
  • Drug: cytarabine
    cons: 75 mg/m2/d IV Push 2 - 5, 9 - 12, 6 - 19, 23 - 26
  • Drug: daunorubicin hydrochloride
    ind: 60 mg/m2 IV 22 and 23
  • Drug: dexamethasone
    main: 10 mg/m2/day PO 1 - 28
  • Drug: doxorubicin hydrochloride
    main: 25 mg/m2 IV 1, 8, 15, and 22
  • Drug: etoposide
    60 mg/kg based on ideal body weight day -3
  • Drug: leucovorin calcium
    5 mg q 6 hours for 4 doses, PO 1, 3, 8, 11 after each methotrexate if WBC < 3,000 /μl
  • Drug: mercaptopurine
    con: 60 mg/m2 PO 1 - 28
  • Drug: methotrexate
    10 mg/m2 IT or IV, d 2, 9, 16, and 23; Maximum 15 mg/admin
  • Drug: prednisone

    ind: 60 mg/m2/d PO 1 - 21*, 22 - 28 Patients will receive full dose through day 8 and then tapered to zero between Day 29 and 42.

    ind2: 60 mg/m2/d PO through day 42

  • Drug: thioguanine
    main: 60 mg/m2/day PO 1 - 14
  • Drug: vincristine sulfate
    ind: 1.4 mg/m2 2 mg max, IV 1, 8, 15, and 22 ind2: 1.4 mg/m2 2 mg max IV 29 and 36 main: 1.5 mg/m2 2 mg max, IV 1, 8, 15, and 22
  • Procedure: allogeneic bone marrow transplantation
    day 0
  • Radiation: radiation therapy
    day -7 through day -4 total dose of radiation is 1,320 cGy.

Primary Outcome Measures :
  1. response

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia FAB class L1-L2 Mixed immunophenotypic markers with no cytochemical myeloid markers allowed No non-Hodgkin's lymphoma No chronic myelogenous leukemia in blast crisis Concurrent registration on the cytogenetics protocol SWOG-9007 required

PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: SWOG 0-3 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times normal (unless elevation due to leukemia) AST no greater than 3 times normal (unless elevation due to leukemia) No chronic liver disease Renal: Creatinine no greater than 2 times normal Cardiovascular: Left ventricular ejection fraction at least 50% by MUGA or echocardiogram No symptomatic congestive heart failure No symptomatic coronary artery disease No cardiomyopathy No uncontrolled arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior remission induction chemotherapy for acute lymphocytic leukemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002665

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Stephen J. Forman, MD City of Hope Comprehensive Cancer Center

Publications of Results:
Sala-Torra O, Gundacker HM, Stirewalt DL, et al.: CTGF (CCN2) predicts OS and DFS in adult acute lymphoblastic leukemia. [Abstract] Blood 106 (11): A-336, 2005.
Slovak ML, Kopecky KJ, Gundacker H, et al.: Clinical significance of cytogenetic abnormalities in adult acute lymphoblastic leukemia (ALL): a Southwest Oncology Group (SWOG) study (S9400). [Abstract] Blood 102 (11 Pt 1): A-2223, 2003.
Boldt DH, Gundacker HM, Lee DY, et al.: Analysis of multidrug resistance gene-1 (MDR1) expression and function in adult acute lymphoblastic leukemia (ALL). A Southwest Oncology Group (SWOG) study. [Abstract] Blood 100 (11 Pt 1): A-2991, 2002.
Gazitt Y, Lee D, Wang ME, et al.: Functional MDR1 expression in adult acute lymphoblastic leukemia (ALL). Blood 92 (10 Suppl 1): A-2788, 676a, 1998.

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Responsible Party: Southwest Oncology Group Identifier: NCT00002665     History of Changes
Other Study ID Numbers: SWOG-9400
SWOG-9400 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2004    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Southwest Oncology Group:
untreated adult acute lymphoblastic leukemia
L1 adult acute lymphoblastic leukemia
L2 adult acute lymphoblastic leukemia
L3 adult acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases
Leukocyte Disorders
Anti-Inflammatory Agents