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A PHASE III STUDY OF LARGE CELL LYMPHOMAS IN CHILDREN AND ADOLESCENTS: COMPARISON OF APO VS APO + IDMTX/HDARA-C AND CONTINUOUS VS BOLUS INFUSION OF DOXORUBICIN


Phase 3
N/A
21 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A PHASE III STUDY OF LARGE CELL LYMPHOMAS IN CHILDREN AND ADOLESCENTS: COMPARISON OF APO VS APO + IDMTX/HDARA-C AND CONTINUOUS VS BOLUS INFUSION OF DOXORUBICIN


OBJECTIVES: I. Compare the event free survival of children with advanced stage large cell
lymphoma treated with modified APO (doxorubicin/prednisone/vincristine/mercaptopurine) with
or without intermediate-dose methotrexate/high dose cytarabine as maintenance therapy
following induction therapy with APO. II. Characterize further the immunophenotypic and
morphologic correlates of pediatric large cell lymphoma.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms, except for those with CNS disease. These patients are assigned to arm II and
receive whole brain irradiation on Regimen B. Arm I: Induction (Modified APO): Patients
receive vincristine IV on days 1, 8, 15, 22, and 29, doxorubicin IV over 15 minutes on days
1 and 22, prednisone three times a day on days 1-28, and methotrexate intrathecally (IT) on
days 1, 8, and 22. Patients in complete remission on day 43 proceed to maintenance, those in
partial remission undergo biopsy then proceed to maintenance, and those with residual
disease receive radiotherapy on regimen A concurrently with maintenance. Maintenance (day 1
is day 43 of Induction): Courses of intermediate dose methotrexate/leucovorin calcium and
high dose cytarabine (ID MTX/CF/HD ARA-C) and modified APO alternate every 3 weeks. Patients
receive a total of 15 courses (8 of ID MTX/CF/HD ARA-C and 7 of Modified APO). ID MTX/CF/HD
ARA-C: Patients receive methotrexate IV over 24 hours on day 1, leucovorin calcium IV or
orally every 6 hours on days 2 and 3, cytarabine IV over 48 hours on days 2 to 4, and
methotrexate IT on day 1 of courses 1, 3, and 5. Filgrastim (G-CSF) is administered
beginning on day 5 and continuing until blood counts recover. Modified APO: Patients receive
vincristine IV on day 1, oral mercaptopurine on days 1-5, doxorubicin IV over 15 minutes on
day 1, and oral prednisone three times a day on days 1-5. Arm II: Induction: Patients
receive treatment as in arm I except that patients with CNS disease also receive
methotrexate IT on days 15, 29, and 36. Maintenance (day 1 is day 43 of Induction): Modified
APO: as in Arm I, with methotrexate administered on day 1 of courses 1, 3, and 5 (days 1-5
for patients with CNS disease). Courses repeat every 21 days for a total of 15 courses.
Patients with CNS disease begin radiotherapy on Regimen B on week 2 of maintenance. Regimen
A: Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of
maintenance. Regimen B: Patients receive whole brain irradiation (5 days a week for 3.1
weeks) beginning on day 1 of maintenance. Patients are followed monthly for 6 months, every
3 months for 18 months, every 6 months for 3 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 242 patients will be accrued for this study over approximately
5.4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Previously untreated large cell lymphoma, including the following
histologic designations: Rappaport classification Diffuse histiocytic Mixed
lymphocytic-histiocytic Working Formulation classification Diffuse large cell, cleaved
and/or noncleaved Immunoblastic Diffuse, mixed small and large cell Lukes-Collins
classification Diffuse large cleaved Diffuse large noncleaved Immunoblastic T or B cell
True histiocytic Updated Kiel classification Cytocentric large cell
Centroblastic-centrocytic T-zone Lymphoepithelioid cell (Lennert's) Immunoblastic T or B
cell Large cell anaplastic Pleomorphic Centroblastic-centrocytic, diffuse Malignant
histiocytosis Murphy stage III/IV HIV-associated lymphoma eligible Any degree of bone
marrow involvement eligible CNS disease eligible (such patients not randomized)

PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hepatic: Not
specified Renal: Not specified Other: Not pregnant or nursing Adequate contraception
required of fertile patients

PRIOR CONCURRENT THERAPY: No prior therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joseph H. Laver, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Federal Government

Study ID:

CDR0000063955

NCT ID:

NCT00002618

Start Date:

December 1994

Completion Date:

Related Keywords:

  • Lymphoma
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Memorial Mission HospitalAsheville, North Carolina  28801
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Via Christi Regional Medical Center-Saint Francis CampusWichita, Kansas  67214