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NCT00002494 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2016-07-04

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 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or 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: Histologically documented diffuse small noncleaved cell lymphoma (category J by IWF) of any stage Nodal or abdominal masses with less than 25% lymphoblasts in marrow are defined as lymphoma OR Histologically documented L3 acute lymphocytic leukemia (ALL) Greater than 25% lymphoblasts in marrow is defined as ALL, regardless of presence of bulky nodal disease Lymphoma requirements include: Documentation of lymphadenopathy, splenomegaly, or hepatomegaly, presence or absence of abdominal masses, and presence or absence of B symptoms Measurable disease other than ascites and pleural effusions, bony disease, and CNS lesions Bidimensionally measurable mass on physical exam, x-ray, or CT, or MRI OR Clearly defined hepatic mass greater than 3.5 cm on CT, MRI, or ultrasound considered to represent lymphoma OR Histologically documented hepatic lymphoma with the liver extending more than 5 cm below the costal margin on quiet respiration ALL requirements include: Documentation of monoclonal surface immunoglobulin by surface immunophenotyping Lymph node biopsy strongly recommended for patients with obvious marrow involvement Disease labeled L3 but also manifested by lymphadenopathy must be evaluated as is lymphoma (see above) PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Any status Life expectancy: At least 2 years Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times normal (unless further elevation is directly attributable to malignancy) Renal: Creatinine no greater than 1.5 times normal (unless further elevation is directly attributable to malignancy) Cardiovascular: No uncontrolled or severe cardiovascular disease, e.g.: No myocardial infarction within the past 6 months No congestive heart failure Other: HIV negative No active, uncontrolled bacterial, viral, or fungal infection No active, uncontrolled duodenal ulcer No other serious medical illness No serious psychiatric condition that would preclude informed consent or protocol compliance No second malignancy within 5 years except: Curatively treated carcinoma in situ of the cervix Curatively treated basal cell carcinoma Not pregnant Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic: No concurrent growth factors Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified Other: No prior therapy
healthy Volunteers
false
minimum Age
15 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive combination therapy as described in the study description. All patients must complete at least the first 3 courses of chemotherapy. Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity. On days 134-139, patients who have had prior bone marrow involvement receive cranial radiation therapy. Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113. Patients are followed monthly for 6 months, every 2 months for 18 months, every 6 months for 2 years, and thereafter for survival.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: cytarabine
    3. Drug: dexamethasone
    4. Drug: doxorubicin hydrochloride
    5. Drug: etoposide
    6. Drug: ifosfamide
    7. Drug: leucovorin calcium
    8. Drug: mesna
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: therapeutic hydrocortisone
    12. Drug: vincristine sulfate
    label
    Combination therapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Combination therapy
    name
    cyclophosphamide
    type
    DRUG
  2. arm Group Labels
    1. Combination therapy
    name
    cytarabine
    type
    DRUG
  3. arm Group Labels
    1. Combination therapy
    name
    dexamethasone
    type
    DRUG
  4. arm Group Labels
    1. Combination therapy
    name
    doxorubicin hydrochloride
    type
    DRUG
  5. arm Group Labels
    1. Combination therapy
    name
    etoposide
    type
    DRUG
  6. arm Group Labels
    1. Combination therapy
    name
    ifosfamide
    type
    DRUG
  7. arm Group Labels
    1. Combination therapy
    name
    leucovorin calcium
    type
    DRUG
  8. arm Group Labels
    1. Combination therapy
    name
    mesna
    type
    DRUG
  9. arm Group Labels
    1. Combination therapy
    name
    methotrexate
    type
    DRUG
  10. arm Group Labels
    1. Combination therapy
    name
    prednisone
    type
    DRUG
  11. arm Group Labels
    1. Combination therapy
    name
    therapeutic hydrocortisone
    type
    DRUG
  12. arm Group Labels
    1. Combination therapy
    name
    vincristine sulfate
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
134
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    complete response
    time Frame
    up to 5 years post-transplant
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 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
detailed Description
OBJECTIVES: I. Determine the response rate and disease free survival of HIV seronegative patients with diffuse small noncleaved cell lymphoma or L3 acute lymphocytic leukemia when treated with high intensity, brief duration combination chemotherapy: alternating courses of ifosfamide/cytarabine/etoposide and cyclophosphamide/doxorubicin, each with methotrexate/vincristine/dexamethasone. II. Determine the toxicity of these regimens in HIV negative patients. OUTLINE: Patients are stratified by participating institution and disease type (diffuse small noncleaved cell lymphoma vs L3 ALL). Patients receive cyclophosphamide IV over 5-10 minutes on days 1 through 5 and oral prednisone on days 1 through 7, followed by alternating courses of: 2) ifosfamide IV over 1 hour on days 8 through 12, methotrexate IV over 24 hours on day 8; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after the first 24 hours) every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M; vincristine IV on day 8; cytarabine IV over 48 hours and etoposide IV over 60 minutes on days 11 and 12; and oral dexamethasone on days 8 through 12, plus triple intrathecal therapy (TIT) with methotrexate, cytarabine, and hydrocortisone on days 8 and 12, and 3) cyclophosphamide IV over 5-10 minutes on days 29 through 33; methotrexate IV over 24 hours and vincristine IV on day 29; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after the first 24 hours) every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M; doxorubicin IV on days 32 and 33; and oral dexamethasone on days 29 through 33, plus TIT on day 29, with doses as above. Patients with CNS disease at diagnosis continue TIT once weekly until the CSF clears, then weekly for 4 more weeks. TIT must be completed prior to initiation of radiotherapy. All patients must complete at least the first 3 courses of chemotherapy. Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity. On days 134-139, patients who have had prior bone marrow involvement receive cranial radiation therapy. Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113. Patients are followed monthly for 6 months, every 2 months for 18 months, every 6 months for 2 years, and thereafter for survival.
Source references
references
  1. citation
    Rizzieri DA, Johnson JL, Niedzwiecki D, Lee EJ, Vardiman JW, Powell BL, Barcos M, Bloomfield CD, Schiffer CA, Peterson BA, Canellos GP, Larson RA. Intensive chemotherapy with and without cranial radiation for Burkitt leukemia and lymphoma: final results of Cancer and Leukemia Group B Study 9251. Cancer. 2004 Apr 1;100(7):1438-48. doi: 10.1002/cncr.20143.
    pmid
    15042678
    type
    RESULT
  2. citation
    Lee EJ, Petroni GR, Schiffer CA, Freter CE, Johnson JL, Barcos M, Frizzera G, Bloomfield CD, Peterson BA. Brief-duration high-intensity chemotherapy for patients with small noncleaved-cell lymphoma or FAB L3 acute lymphocytic leukemia: results of cancer and leukemia group B study 9251. J Clin Oncol. 2001 Oct 15;19(20):4014-22. doi: 10.1200/JCO.2001.19.20.4014.
    pmid
    11600602
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        phology:</strong> Patients with L3 morphology showed improved outcomes, as evidenced in a completed Cancer and Leukemia Group B study (<a href="/clinicaltrials/NCT00002494">CLB-9251</a> [NCT00002494]), when treated according to specific treatment algorithms.[<a href="#cit/section_1.8">8</a>,<a href="#cit/section_1.9">9</a>] This
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        with L3 morphology showed improved outcomes, as evidenced in a completed Cancer and Leukemia Group B study (<a href="/clinicaltrials/NCT00002494">CLB-9251</a> [NCT00002494]), when treated according to specific treatment algorithms.[<a href="#cit/section_1.8">8</a>,<a href="#cit/section_1.9">9</a>] This study found that L3 leuke
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        not usually cured with typical ALL regimens. Aggressive, brief-duration, high-intensity regimens, including those previously used in <a href="/clinicaltrials/NCT00002494">CLB-9251</a> (NCT00002494), that are similar to those used in aggressive non-Hodgkin lymphoma have shown high response rates and cure rates (75% complete resp
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        ical ALL regimens. Aggressive, brief-duration, high-intensity regimens, including those previously used in <a href="/clinicaltrials/NCT00002494">CLB-9251</a> (NCT00002494), that are similar to those used in aggressive non-Hodgkin lymphoma have shown high response rates and cure rates (75% complete response rate; 40% failure-free
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      Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 17, 2025
        datetime
        2025-03-17T12:00:00Z
        display
        March 17, 2025

    Preserved source evidence · Not medical advice