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

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
etoposide
leucovorin calcium
methotrexate
methylprednisolone
therapeutic hydrocortisone
thiotepa
vincristine sulfate
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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, recurrent adult non-Hodgkin lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult Burkitt lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, stage IV childhood large cell lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Newly diagnosed undifferentiated nonlymphoblastic non-Hodgkin's lymphoma (Burkitt's or non-Burkitt's) Newly diagnosed large cell lymphoma with CNS involvement Recurrent non-Hodgkin's lymphoma L-3 and B-cell leukemia included At least 1 of the following required: LDH at least 500 IU/liter (old method) or 2,000 IU/liter (new method) Bone marrow involvement (greater than 5% lymphoblasts) CNS involvement (lymphoblasts on CSF cytospin or intracranial mass on CT or MRI scan) PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Prior therapy allowed for non-Hodgkin's lymphoma No prior therapy for all other diseases

Sites / Locations

  • University of Michigan Comprehensive Cancer Center
  • Kaplan Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Children's Hospital of Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 19, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002471
Brief Title
Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Official Title
Phase II Trial of Intensive, Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 1990 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. 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 in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: I. Improve the survival of children and adolescents with poor-risk nonlymphoblastic lymphoma and acute B-lymphoblastic leukemia using an intensive, short-course regimen of combination chemotherapy. II. Assess the toxicity of the regimen. OUTLINE: Nonrandomized study. Induction: 7-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy (TIT). Cyclophosphamide, CTX, NSC-26271; Thiotepa, TSPA, NSC-6396; Vincristine, VCR, NSC-67574; Daunorubicin, DNR, NSC-82151; Dexamethasone, DM, NSC-34521; Etoposide, VP-16, NSC-141540; Methotrexate, MTX, NSC-740; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590; plus TIT: IT MTX; IT Cytarabine, IT ARA-C, NSC-63878; IT Hydrocortisone, IT HC, NSC-10483. Consolidation: 6-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT. ARA-C; VP-16; Asparaginase (E. coli), ASP, NSC-109229; MTX; VCR; Methylprednisolone, MePRDL, NSC-19987; with CF; plus TIT. Reinduction: 7-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT. CTX; TSPA; VCR; DNR; DM; VP-16; MTX; with CF; plus TIT. PROJECTED ACCRUAL: A maximum of 30 patients, accrued from 4 institutions, will be entered. If at any time more than 3 patients are not "event free", the trial will be terminated early, with patients considered event free if they enter remission, do not die as a result of treatment toxicity, and do not experience progression within 1 year from the start of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
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, recurrent adult non-Hodgkin lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult Burkitt lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, stage IV childhood large cell lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
asparaginase
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
therapeutic hydrocortisone
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed undifferentiated nonlymphoblastic non-Hodgkin's lymphoma (Burkitt's or non-Burkitt's) Newly diagnosed large cell lymphoma with CNS involvement Recurrent non-Hodgkin's lymphoma L-3 and B-cell leukemia included At least 1 of the following required: LDH at least 500 IU/liter (old method) or 2,000 IU/liter (new method) Bone marrow involvement (greater than 5% lymphoblasts) CNS involvement (lymphoblasts on CSF cytospin or intracranial mass on CT or MRI scan) PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Prior therapy allowed for non-Hodgkin's lymphoma No prior therapy for all other diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma Wollner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States
Facility Name
Kaplan Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Finlay JL, Wasserman R, Willoughby M, et al.: A pilot study of brief intensive chemotherapy for children with high-risk small non-cleaved cell lymphoma (SNCCL) and acute B-cell leukemmia (B-ALL). Med Pediatr Oncol 21(8): A-18, 535, 1993.
Results Reference
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Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

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