A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

NCT01920737 | Active Not Recruiting Phase 2

• 1 other identifier: 12-266
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to find out whether the combination of chemotherapy drugs that are routinely used in children with ALL, will be safe and effective in treating adult patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy drugs that are given in different combinations and in several steps. In adult ALL there is no standard which drugs to give and how to combine them. Some leukemias have a chromosome abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do not (called Ph Negative). In this study we want to see whether this combination of chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative ALL.

Conditions

Leukemia

Keywords

ALL; Bone Marrow; Ph Negative; Daunorubicin; Vincristine; Prednisone; PEG-Asparaginase; Methotrexate; 16-MP (6-Mercaptopurine); Cyclophosphamide; Cytarabine; Leucovorin; Dexamethasone; 12-266

Outcome Measures

Primary Outcomes (1)

• rate of molecular remission

  i.e. minimal residual disease (MRD) negative status, as assessed by PCR and flow cytometry in the bone marrow after phase I induction.

  1 year

Secondary Outcomes (6)

• complete remission (CR)

  1 year

• overall survival (OS)

  1 year

• event-free survival (EFS)

  1 year

• disease free survival (DFS) rates

  1 year

• minimal residual disease (MRD) status

  1 year

Study Arms (1)

Leukemia Patients

EXPERIMENTAL

The treatment plan has 6 treatment cycles. The cycle names are listed in the following order: Induction Phase I - Induction Phase II - Intensification I - Re-induction I - Intensification II - Re-induction II Each cycle is given over a period of 4-6 weeks and the interval between them can range between 1-3 weeks. Based the patients medical condition, the doctor may decide to change the timing of the drugs, the interval between the drugs in a cycle, or the interval between the cycles. After receiving all cycles you will continue with a 36 months treatment part that is called Maintenance.

Drug: Daunorubicin; Drug: Vincristine; Drug: Prednisone; Drug: PEG-Asparaginase; Drug: Methotrexate; Drug: 6-MP (6-Mercaptopurine); Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Leucovorin; Drug: Dexamethasone; Other: Blood draw; Device: CT/PET scans

Interventions

Daunorubicin DRUG

In the event of a shortage of daunorubicin, doxorubicin may be used as a substitute.

Leukemia Patients

Vincristine DRUG

Leukemia Patients

Prednisone DRUG

Leukemia Patients

PEG-Asparaginase DRUG

Leukemia Patients

Methotrexate DRUG

Leukemia Patients

6-MP (6-Mercaptopurine) DRUG

Leukemia Patients

Cyclophosphamide DRUG

Leukemia Patients

Cytarabine DRUG

Leukemia Patients

Leucovorin DRUG

Leukemia Patients

Dexamethasone DRUG

Leukemia Patients

Blood draw OTHER

Leukemia Patients

CT/PET scans DEVICE

PET or CT scan every 6 months for 3 years

Leukemia Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Previously untreated Ph negative precursor B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain Patients who have untreated B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain, but Ph status is unknown, may also enroll.
• Patients with T-cell or B cell lymphoblastic lymphoma confirmed by conventional immature T- or pre B cell markers even if the bone marrow is not involved are also eligible
• Age 18 - 60 years
• ECOG performance status of 0-2
• Adequate renal function as demonstrated by a serum creatinine ≤ 2.0 mg/dl or a creatinine clearance of \> 60 ml/min.
• Adequate hepatic function as demonstrated by a total bilirubin \< 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia
• Normal cardiac function as demonstrated by a left ventricular ejection fraction ≥ 50% on echocardiogram or MUGA scan
• Negative serum pregnancy test in women of childbearing potential
• Men and women of childbearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished.
• Patients with central nervous system involvement by ALL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice. For patients with CNS disease, dexamethasone may be temporarily administered instead of prednisone to reduce CNS pressure, at the discretion of the treating physician and after discussion with the MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per protocol for 28 days.

You may not qualify if:

• Previous treatment for ALL, except for prior steroids and/or hydroxyurea
• Patients known to have Philadelphia (Ph)+ ALL are not eligible. Leukemia cell samples will be obtained from all patients enrolled before starting protocol treatment and submitted for Philadelphia chromosome testing by either karyotyping, or for bcr/abl1 translocation by FISH or by PCR for bcr/abl1. Patients who are later found to have Ph+ ALL should have treatment on this trial discontinued and will not be considered in the evaluation
• Lymphoid blastic crisis of chronic myelogenous leukemia
• Mature B-cell (Burkitt's) ALL
• Active serious infections not controlled by antibiotics
• Pregnant women or women who are breast-feeding
• Concurrent active malignancy requiring immediate therapy
• Clinically significant cardiac disease (NY Heart Association Class III or IV), including chronic arrhythmias, or pulmonary disease
• Known HIV positive status
• Other serious or life-threatening conditions deemed unacceptable by the principal investigator

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Shire: collaborator
• Duke University: collaborator
• Weill Medical College of Cornell University: collaborator
• Lehigh Valley Health Network: collaborator

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medical Center

New York, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

• Geyer MB, Ritchie EK, Rao AV, Vemuri S, Flynn J, Hsu M, Devlin SM, Roshal M, Gao Q, Shukla M, Salcedo JM, Maslak P, Tallman MS, Douer D, Park JH. Pediatric-inspired chemotherapy incorporating pegaspargase is safe and results in high rates of minimal residual disease negativity in adults up to age 60 with Philadelphia chromosome-negative acute lymphoblastic leukemia. Haematologica. 2021 Aug 1;106(8):2086-2094. doi: 10.3324/haematol.2020.251686.

  PMID: 33054114 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia

Interventions

Daunorubicin; Vincristine; Prednisone; pegaspargase; Methotrexate; Mercaptopurine; Cyclophosphamide; Cytarabine; Leucovorin; Dexamethasone; Blood Specimen Collection; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Aminopterin; Pterins; Pteridines; Sulfhydryl Compounds; Sulfur Compounds; Purines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes; Pregnadienetriols; Steroids, Fluorinated; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Jae Park, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 12, 2013
• Study Start: August 7, 2013
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (3)