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Treatment Protocol for T-Cell and B-Precursor Cell Lymphoblastic Lymphoma of the European Inter-Group Co-Operation on Childhood Non-Hodgkin-Lymphoma (EICNHL)


Phase 3
N/A
21 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Treatment Protocol for T-Cell and B-Precursor Cell Lymphoblastic Lymphoma of the European Inter-Group Co-Operation on Childhood Non-Hodgkin-Lymphoma (EICNHL)


OBJECTIVES:

Primary

- Compare the event-free survival of young patients with newly diagnosed lymphoblastic
lymphoma treated with induction prednisolone vs dexamethasone.

- Compare the safety of standard maintenance treatment over 18 months vs 24 months in
these patients.

Secondary

- Determine prognostic factors highly predicative for treatment failure in patients
treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

- Cytoreductive prephase: All patients receive methotrexate intrathecally (IT) once on
day 1 and prednisolone IV or orally 3 times daily on days 1-7.

- Induction phase (part 1): Patients with T-cell lymphoblastic lymphoma (T-LBL) are
randomized to 1 of 2 induction treatment arms. Patients with LBL with an unknown
immunophenotype are assigned to arm I. Patients with precursor B-cell lymphoblastic
lymphoma (pB-LBL) are assigned to arm II.

- Arm I (T-LBL or LBL with an unknown immunophenotype): Patients receive
prednisolone IV or orally 3 times daily on days 8-28; vincristine IV and
daunorubicin hydrochloride IV over 1 hour on days 8, 15, 22, and 29; asparaginase
IV over 1 hour on days 12, 15, 18, 21, 24, 27, 30, and 33; and methotrexate IT on
days 12 and 33; Patients with CNS involvement receive additional methotrexate IT
on days 18 and 27. Patients then proceed to part 2 of the induction phase.

- Arm II (T-LBL or pB-LBL): Patients receive dexamethasone IV or orally 3 times
daily on days 8-28. Patients also receive vincristine, daunorubicin hydrochloride,
asparaginase, and methotrexate as in arm I. Patients then proceed to part 2 of the
induction phase.

- Induction phase (part 2): Patients receive cyclophosphamide IV over 1 hour on days 36
and 64; cytarabine IV on days 38-41, 45-48, 52-55, and 59-62; oral mercaptopurine on
days 36-63; and methotrexate IT on days 45 and 59. Two weeks later, patients proceed to
protocol M.

- Protocol M: Patients receive oral mercaptopurine once daily on days 1-56 and high-dose
methotrexate IV continuously over 24 hours, and methotrexate IT on days 8, 22, 36, and
50. Patients also receive leucovorin calcium IV 42, 48, and 54 hours after the start of
high-dose methotrexate infusion. Patients are then stratified according to stage of
disease (I or II vs III or IV). Patients with stage I or II disease proceed directly to
maintenance therapy 2 weeks after completion of protocol M. Patients with stage III or
IV disease proceed to the re-induction phase 2 weeks after completion of protocol M.

- Re-induction phase: Patients receive dexamethasone IV or orally 3 times daily on days
1-21; vincristine IV and doxorubicin hydrochloride IV over 1 hour on days 8, 15, 22,
and 29; asparaginase IV over 1 hour on days 8, 11, 15, and 18; cyclophosphamide IV over
1 hour on day 36; cytarabine IV on days 38-41 and 45-48; oral thioguanine on days
36-49; and methotrexate IT on days 38 and 45. Patients proceed to maintenance therapy 2
weeks after completion of the re-induction phase.

- Maintenance therapy: Patients with T-LBL are randomized to 1 of 2 maintenance treatment
arms. Patients with pB-LBL or LBL with an unknown immunophenotype are assigned to arm
I. Any patients with evidence of initial CNS involvement undergo cranial radiotherapy
before starting maintenance therapy. Patients must show no evidence of progressive
disease before starting maintenance therapy.

- Arm I: Patients receive oral mercaptopurine once a day and oral methotrexate once
a week for up to 2 years (from the first day of the cytoreductive phase) in the
absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive treatment as in arm I for up to 1½ years (from the first
day of the cytoreductive phase) in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: Approximately 600 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed lymphoblastic lymphoma (LBL)

- Stage I-IV disease

- T-cell LBL, precursor B-cell LBL, or LBL with an unknown immunophenotype

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- No known HIV or AIDS infection

- No severe immunodeficiency

- No other prior malignancy

- No prior disease that would preclude treatment with chemotherapy

PRIOR CONCURRENT THERAPY:

- More than 2 months since prior systemic corticosteroids for a duration of > 8 days

- No prior chemotherapy

- No prior radiotherapy

- No prior organ transplant

- No trimethoprim-sulfamethoxazole 6 days before or during methotrexate therapy

- No concurrent participation in another clinical trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Conditional event-free survival

Safety Issue:

No

Principal Investigator

Robert F. Wynn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Manchester Children's Hospital

Authority:

Unspecified

Study ID:

CDR0000454508

NCT ID:

NCT00275106

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Non-Hodgkin

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