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Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia

NCT ID: NCT00002499

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1990-01-31

Brief Summary

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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/III trial to study the effectiveness of combination chemotherapy in treating children with relapsed acute lymphocytic leukemia.

Detailed Description

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OBJECTIVES: I. Evaluate the feasibility, at GATLA, of a study of the treatment of ALL in first hematologic relapse following treatment on a BFM protocol. II. Evaluate the efficacy of induction with vincristine/daunorubicin/asparaginase/prednisone in producing a second complete remission in these patients, and evaluate the toxicity of this regimen. III. Evaluate the efficacy and toxicity of the Capizzi I regimen (vincristine/asparaginase/methotrexate) and Capizzi II regimen (cytarabine/asparaginase/daunorubicin) when given to maintain and prolong complete remission. IV. Offer the option of bone marrow transplantation to those patients who are in second remission and who have a histocompatible donor, and compare outcome of these patients with those on chemotherapy alone.

OUTLINE: Nonrandomized study. Patients achieving remission on Induction proceed to Interim Maintenance, then to Continued Maintenance; those failing to achieve remission receive Salvage Re-induction, followed, if remission is achieved, by Interim Maintenance, then Continued Maintenance. Induction: 4-Drug Combination Chemotherapy with CNS Prophylaxis/Therapy. Vincristine, VCR, NSC-67574; Prednisone, PRED, NSC-10023; Asparaginase, ASP, NSC-109229; Daunorubicin, DNR, NSC-82151; with Intrathecal Cytarabine, IT ARA-C, NSC-63878; Intrathecal Dexamethasone, IT DM, NSC-34521. Interim Maintenance: 3-Drug Combination Chemotherapy with, as indicated, Radiotherapy. VCR; ASP; Methotrexate, MTX, NSC-740; with, as indicated, testicular irradiation (equipment not specified). Continued Maintenance: 3-Drug Combination Chemotherapy followed by 3-Drug Combination Chemotherapy with CNS Prophylaxis and, as indicated, Radiotherapy. Capizzi II: ARA-C; ASP; DNR; followed by Capizzi I: VCR; ASP; MTX; with IT ARA-C; IT DM; and, as indicated, cranial irradiation (equipment not specified). Salvage Re-induction: 2-Drug Combination Chemotherapy. ARA-C; ASP.

PROJECTED ACCRUAL: At least 72 evaluable patients will be entered. Accrual is expected to be completed in 3 years.

Conditions

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Leukemia

Keywords

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recurrent childhood acute lymphoblastic leukemia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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asparaginase

Intervention Type DRUG

cytarabine

Intervention Type DRUG

daunorubicin hydrochloride

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

methotrexate

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: ALL in first hematologic relapse during or following completion of treatment on a BFM protocol (ARG-GATLA-1-LLA-82, -84, -87, or -90) M2-M3 bone marrow required

PATIENT CHARACTERISTICS: Age: Under 20 Performance status: Not specified Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: No significant liver disease Renal: No significant kidney disease Cardiovascular: No significant heart disease Pulmonary: No significant lung disease Other: No significant digestive disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior total anthracycline no greater than 280 mg/sqm Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not applicable
Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Argentino de Tratamiento de la Leucemia Aguda

OTHER

Sponsor Role lead

Principal Investigators

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Federico Sackmann-Muriel, MD

Role: STUDY_CHAIR

Hospital de Pediatria Garrahan

Locations

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Grupo Argentino de Tratamiento de la Leucemia Aguda

Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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Argentina

Other Identifiers

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ARG-GATLA-1LLAREC90

Identifier Type: -

Identifier Source: secondary_id

NCI-F92-0006

Identifier Type: -

Identifier Source: secondary_id

CDR0000077835

Identifier Type: -

Identifier Source: org_study_id