CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

NCT00176462 | Completed Phase 2 Results

• 3 other identifiers: 0201010220003389P30CA072720
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.

Conditions

Acute Lymphocytic Leukemia

Keywords

Acute Lymphocytic Leukemia; Leukemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years

  This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.

  5 years

Secondary Outcomes (1)

• To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis

  5 years

Study Arms (2)

Arm 1 Standard Risk

EXPERIMENTAL

6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin

Drug: L-asparaginase; Drug: daunomycin; Drug: dexamethasone; Drug: 6-mercaptopurine; Drug: methotrexate; Drug: vincristine; Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone); Drug: Leucovorin

Arm 2 High Risk

EXPERIMENTAL

6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C

Drug: aminopterin; Drug: L-asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunomycin; Drug: dexamethasone; Drug: 6-mercaptopurine; Drug: 6-thioguanine; Drug: vincristine; Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone); Drug: Leucovorin

Interventions

aminopterin DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 2 High Risk

L-asparaginase DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 1 Standard Risk; Arm 2 High Risk

cyclophosphamide DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 2 High Risk

cytarabine DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 2 High Risk

daunomycin DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 1 Standard Risk; Arm 2 High Risk

dexamethasone DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 1 Standard Risk; Arm 2 High Risk

6-mercaptopurine DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 1 Standard Risk; Arm 2 High Risk

methotrexate DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 1 Standard Risk

6-thioguanine DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 2 High Risk

vincristine DRUG

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Arm 1 Standard Risk; Arm 2 High Risk

Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone) DRUG

Arm 1 Standard Risk; Arm 2 High Risk

Leucovorin DRUG

Arm 1 Standard Risk; Arm 2 High Risk

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive)
• Patients with overt CNS (central nervous system) or testicular disease are eligible
• Informed consent according to institutional and FDA guidelines.
• Adequate organ function is required.
• HIV seropositive patients will not be excluded from this study.
• Patients greater than 1 year of age and less than 29.99 years of age are eligible.

You may not qualify if:

• Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible.
• All patients with evidence of significant organ dysfunction not thought to be attributable to ALL (patients with clinically significant congestive heart failure, cardiac ejection fraction \<40%, total bilirubin \>2, serum creatinine \>2) will be ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note: Patients with total bilirubin \>2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl transferase.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Jersey Shore University Medical Center

Neptune City, New Jersey, 07754, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Interventions

Aminopterin; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Mercaptopurine; Methotrexate; Thioguanine; Vincristine; Hydrocortisone; Leucovorin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Sulfhydryl Compounds; Sulfur Compounds; Purines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes

Limitations and Caveats

Antifolate therapy was non-randomly assigned, therefore, we do not have a statistical basis to compare the toxicity observed among patients on the standard risk and high risk treatment arms.

Results Point of Contact

• Title: Richard Drachtman, MD
• Organization: Rutgers Cancer Institute of New Jersey

drachtri@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu

732-235-8675

Study Officials

• Barton Kamen, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2001
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

US (2)