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

NCT ID: NCT01920737

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-07
• Study Completion Date: 2026-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leukemia Patients

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.

Group Type: EXPERIMENTAL

Daunorubicin

Intervention Type: DRUG

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

Vincristine

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

PEG-Asparaginase

Intervention Type: DRUG

Methotrexate

Intervention Type: DRUG

6-MP (6-Mercaptopurine)

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Leucovorin

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Blood draw

Intervention Type: OTHER

CT/PET scans

Intervention Type: DEVICE

PET or CT scan every 6 months for 3 years

Interventions

Daunorubicin

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

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

PEG-Asparaginase

Intervention Type: DRUG

Methotrexate

Intervention Type: DRUG

6-MP (6-Mercaptopurine)

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Leucovorin

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Blood draw

Intervention Type: OTHER

CT/PET scans

PET or CT scan every 6 months for 3 years

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Lehigh Valley Health Network

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Park, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33054114 (View on PubMed)

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

12-266

Identifier Type: -

Identifier Source: org_study_id