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PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA


OBJECTIVES:

- Provide a standard protocol for specific therapy that is relatively easy to administer
and relatively inexpensive but conforms to modern treatment principles, and determine
whether such therapy can be administered safely and effectively in patients with acute
lymphoblastic lymphoma or diffuse non-Hodgkin's lymphoma who live in developing
countries.

- Determine the rates of relapse and survival in patients treated with these protocols,
and relate this data to disease subtype and clinical presentation in order to obtain a
database on which to build future stratagems.

OUTLINE: This is a multicenter study.

Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma with any degree of bone
marrow involvement are assigned to Protocol MCP-841. Patients with mediastinal or localized
lymphoblastic lymphoma (a single nodal or extranodal site) without bone marrow involvement,
or other types of diffuse non-Hodgkin's lymphoma with or without bone marrow involvement are
assigned to Protocol MCP-842.

Protocol MCP-841:

- First induction therapy: Patients receive daunorubicin (DNR) IV on days 8, 15, and 29;
vincristine (VCR) IV on days 1, 8, 15, 22, and 29; asparaginase (ASP) intramuscularly
(IM) every other day on days 2-20; oral prednisone (PRED) on days 1-28; and
methotrexate (MTX) intrathecally (IT) on days 1, 8, 15, and 22. Second induction
therapy: Patients receive oral mercaptopurine (MP) on days 1-7 and 15-21;
cyclophosphamide (CTX) IV over 30 minutes on days 1 and 15; MTX IT as in first
induction therapy; and cranial irradiation on days 4-14.

- Alternative to second induction (if a cranial irradiation facility is unavailable):
Patients receive MP and CTX as in second induction therapy; cytarabine (ARA-C) IV every
12 hours on days 1, 2, 15, 16, 29, and 30; and MTX IT on days 8 and 22.

Patients with low-risk disease (WBC no greater than 10,000/mm3, age 3 to 6 years, no
prominent lymphadenopathy (less than 3 cm in diameter in each nodal region), normal CSF, no
mediastinal mass, no enlargement of liver or spleen, and no cranial nerve palsies) proceed
directly to maintenance therapy. All other patients are considered high risk, and they
repeat first induction therapy and then proceed to consolidation therapy.

- Consolidation therapy: Patients receive MP and CTX as in second induction therapy, VCR
IV on days 1 and 15, and ARA-C subcutaneously (SC) every 12 hours on days 1-3 and
15-17.

- Maintenance therapy: Patients receive VCR IV on day 1; DNR IV on day 1; oral PRED on
days 1-7; ASP IM on days 1, 3, 5, and 7; and oral MTX once weekly and oral MP daily on
days 15-35, 43-63, and 71-91. Maintenance therapy continues for a total of 6 courses.

Protocol MCP-842:

- Patients undergo surgical resection of intra-abdominal masses, if feasible. Patients
with low-risk disease (completely resected tumor or a single extra-abdominal site of
involvement (other than the mediastinum), but without lymphoblastic lymphoma) are
assigned to treatment group 2. All other patients, including those with lymphoblastic
lymphoma without bone marrow involvement, are considered high risk and they are
assigned to treatment group 1.

- Group 1 (high risk): Patients receive one course of regimen A comprising CTX IV over 15
minutes on days 1-4; VCR IV on days 1, 8, and 15; doxorubicin (DOX) IV on days 1 and 2;
ARA-C IV over 3 hours every 12 hours on day 1; ARA-C IT on day 4; and MTX IT on days 8
and 12. Patients then receive one course of regimen B comprising ifosfamide IV over 30
minutes on days 1-5, etoposide IV over 1 hour and MTX IV on days 1-3, VCR IV on day 8,
ARA-C IT on days 1 and 4, and MTX IT as in regimen A. Patients then receive a second
course of regimen A, followed by a second course of regimen B.

- Group 2 (low risk): Patients receive one course of regimen A, followed by one course of
regimen B, and then a second course of regimen A. DOX is withheld during both courses
of regimen A. IT therapy is withheld during the second course of regimen A.

Patients are followed every 2 months for 1 year (Protocol MCP-841) or at 1, 2, 3, 4, 6, and
8 months (Protocol MCP-842), every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed acute lymphoblastic leukemia (ALL)

- Lymphoblasts comprising more than 25% of nucleated cells on bone marrow aspirate

- Associated with an appropriate clinical syndrome

- OR

- Histologically proven newly diagnosed diffuse non-Hodgkin's lymphoma (NHL)

- Immunologic and/or cytochemical confirmation of diagnosis preferred

PATIENT CHARACTERISTICS:

Age:

- ALL:

- Under 25

- NHL:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No prior therapy for ALL or NHL

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ian Trevor Magrath, MD, FRCP, FRCPath

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000077227

NCT ID:

NCT00018954

Start Date:

October 1992

Completion Date:

October 2002

Related Keywords:

  • Leukemia
  • Lymphoma
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • untreated adult acute lymphoblastic leukemia
  • untreated childhood acute lymphoblastic leukemia
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage I childhood large cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182