Study on a New Treatment Plan for Adults Aged 18-60 with Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT01920737

This clinical trial is testing a new combination of chemotherapy drugs, inspired by treatments used in children, to see if they are safe and effective for adults with a specific type of leukemia called Ph Negative Acute Lymphoblastic Leukemia (ALL).

Patient Parameters

Program Overview

The study aims to determine if a combination of chemotherapy drugs, typically used in children with Acute Lymphoblastic Leukemia (ALL), can be safely and effectively used to treat adults with the same condition. In adults, there is no standard treatment for ALL, and this study focuses on those without a specific chromosome abnormality known as the Philadelphia chromosome (Ph Negative). Researchers want to see if this new drug combination can help treat adult patients with Ph Negative ALL.

Eligibility Criteria

Inclusion Criteria

  • Have not received previous treatment for Ph Negative precursor B-cell or T-cell ALL, confirmed by specific lab tests.
  • Patients with T-cell or B-cell lymphoblastic lymphoma, even if the bone marrow is not involved, are eligible.
  • Aged between 18 and 60 years.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Have good kidney function, shown by specific blood test results.
  • Have good liver function, with certain blood test results within normal limits.
  • Have normal heart function, with a heart pumping ability of 50% or more.
  • Women of childbearing age must have a negative pregnancy test.
  • Men and women of childbearing age must agree to use effective birth control during treatment and for at least 4 months after.
  • Patients with leukemia affecting the central nervous system can participate and may receive additional treatments like radiation or specific chemotherapy as needed.

Exclusion Criteria

  • Have received previous treatment for ALL, except for certain medications like steroids or hydroxyurea.
  • Have Philadelphia chromosome-positive (Ph+) ALL.
  • Have a specific type of leukemia crisis related to chronic myelogenous leukemia.
  • Have a type of ALL known as Mature B-cell (Burkitt's) ALL.
  • Have active serious infections not controlled by antibiotics.
  • Are pregnant or breastfeeding.
  • Have another active cancer that needs immediate treatment.
  • Have significant heart or lung disease.
  • Are known to be HIV positive.
  • Have other serious or life-threatening conditions that the study leader considers unacceptable.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Weill Cornell Medical CenterNew YorkNew York
Duke University Medical Center27701DurhamNorth Carolina

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