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A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All

Phase 3
22 Years
Not Enrolling
Leukemia, Lymphoma

Thank you

Trial Information

A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All


- Determine if increasing the methotrexate dose in combination with standard treatment is
feasible in patients with advanced small noncleaved cell non-Hodgkin's lymphoma or
B-cell acute lymphocytic leukemia.

- Assess the toxicity of this intensified therapy in these patients.

- Assess the feasibility of treating these patients that have CNS disease at diagnosis
with this intensified therapy plus etoposide and ifosfamide.

- Assess toxicities and late effects of this intensive therapy on the central nervous
system, cardiac function, and fertility in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to stage and disease
(stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL with no CNS involvement vs stage IV
NHL with CNS involvement vs B-cell acute lymphocytic leukemia (B-ALL) with no CNS
involvement vs B-ALL with CNS involvement).

Patients receive methotrexate and cytarabine intrathecally on days 1, 4, 11, and 36 (on day
40 for patients with stage IV NHL or B-ALL only) in combination with alternating courses of:
A) cyclophosphamide IV every 12 hours for a total of six doses on days 1-3, doxorubicin IV
over 30 minutes on day 4, vincristine IV on days 4 and 11, dexamethasone IV or orally twice
daily on days 1-5, and filgrastim (G-CSF) subcutaneously (SQ) or IV over 30 minutes
beginning on day 5 and continuing until blood counts recover and B) methotrexate IV over 24
hours on day 18, methotrexate intrathecally on day 18, dexamethasone IV or orally twice
daily on days 18-22, leucovorin calcium IV or orally every 6 hours for a total of 6 doses on
days 20-21, cytarabine IV over 48 hours on days 20-21, and G-CSF SQ or IV over 30 minutes
beginning on day 22 and continuing until blood counts recover. Patients with stage III NHL
receive at total of 5 courses of treatment (A-B-A-B-A) and patients with stage IV NHL or
B-ALL with no CNS involvement receive a total of 6 courses of treatment (A-B-A-B-A-B).

Patients with CNS involvement receive a third course of treatment: C) etoposide IV over 1
hour on days 36-40, ifosfamide IV over 1 hour on days 36-40, oral dexamethasone twice daily
on days 36-40, and G-CSF SQ or IV over 30 minutes beginning on day 41 and continuing until
blood counts recover. Patients with CNS involvement receive a total of 7 courses of
treatment (A-B-C-A-B-A-B).

Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 27-80 patients will be accrued for this study over 24 months.

Inclusion Criteria


- One of the following diagnoses:

- Histologically confirmed small noncleaved cell non-Hodgkin's lymphoma

- Stage III or IV

- Burkitt's or non-Burkitt's by the Working Formulation OR

- Burkitt's or Burkitt's-like by the REAL classification

- Histologically confirmed B-cell acute lymphocytic leukemia

- At least 25% blasts in bone marrow

- FAB L3 morphology

- FAB L1 morphology allowed if blasts show B-cell markers (CD19, 20, 22) and
surface immunoglobulin positivity

- Must be registered on POG-9900 in past 8 days



- Under 22 at time of diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- Not pregnant or nursing

- Negative pregnancy test

- HIV positive allowed


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- No concurrent use of dexamethasone as antiemetic


- Not specified


- Prior surgery allowed


- No prior therapy except surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Hazem H. Mahmoud, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Carol G. Simon Cancer Center at Morristown Memorial Hospital


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • childhood Burkitt lymphoma
  • L3 childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • L3 adult acute lymphoblastic leukemia
  • B-cell adult acute lymphoblastic leukemia
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



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