NCT00501826 · M.D. Anderson Cancer Center
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
What this study is about
This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma.
View original scientific description
This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Interventions
DRUG
Cyclophosphamide
Given IV
DRUG
Cytarabine
Given IV
DRUG
Dexamethasone
Given IV or PO
DRUG
Doxorubicin Hydrochloride
Given IV
DRUG
Mercaptopurine
Given PO
DRUG
Methotrexate
Given IV and PO
DRUG
Nelarabine
Given IV
DRUG
Pegaspargase
Given IV
DRUG
Prednisone
Given PO
DRUG
Venetoclax
Given PO
DRUG
Vincristine Sulfate
Given IV
Primary outcome measures
Complete remission rate
Time frame: 3 years
The sample size will provide an estimate of relapse rate at 3 years with a 95% confidence interval of width +/- 10%.
Duration of remission
Time frame: Up to 9 years
Duration of remission will be evaluated.
Progression-free survival
Time frame: 3 years
Progression-free survival will be estimated.
Overall survival
Time frame: 3 years
Overall survival will be estimated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =\< 2 courses are also eligible
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3
- Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN)
- Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable
Exclusion criteria
- Pregnant or nursing women
Where
- Houston, Texas
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations