Combination Chemotherapy in Treating Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT01005758 | Unknown Phase 2

• 4 other identifiers: CDR0000632144OSU-080662008C0112DFCI-06254
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of combination chemotherapy and to see how well it works in treating adult patients with newly diagnosed acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

untreated adult acute lymphoblastic leukemia; Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia; L1 adult acute lymphoblastic leukemia; L2 adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (2)

• Feasibility of intensification therapy, measured as the percentage of patients who, having achieved a complete remission after induction therapy, receive > 25 weeks of pegaspargase IV as part of intensification therapy

• Toxicity

Secondary Outcomes (3)

• Complete remission rate

• Disease-free and overall survival

• Prognostic significance of prednisone prophase response, minimal residual disease at various time points, tyrosine kinase mutations, and gene expression profiles at diagnosis

Interventions

cyclophosphamide DRUG

cytarabine DRUG

dexamethasone DRUG

doxorubicin hydrochloride DRUG

etoposide phosphate DRUG

hydrocortisone sodium succinate DRUG

imatinib mesylate DRUG

mercaptopurine DRUG

methotrexate DRUG

methylprednisolone DRUG

pegaspargase DRUG

prednisolone DRUG

prednisone DRUG

vincristine sulfate DRUG

laboratory biomarker analysis OTHER

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) * No known mature B-cell ALL\*, defined by the presence of surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8) * Patients with T-cell surface markers and t(8;14)(q24;q11) are eligible NOTE: \*Patients with mature B-cell ALL will be removed from the study as soon as that diagnosis is made. * No secondary ALL (i.e., ALL arising after another malignancy) PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known HIV positivity (HIV testing is not required) * No comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives * No active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely PRIOR CONCURRENT THERAPY: * No prior anti-leukemic therapy except ≤ 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis * Patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study * No concurrent chronic steroids or anti-metabolite therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; etoposide phosphate; Hydrocortisone; Imatinib Mesylate; Mercaptopurine; Methotrexate; Methylprednisolone; pegaspargase; Prednisolone; Prednisone; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Piperazines; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Study Officials

• William G. Blum, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2009-10