Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 days, 30 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients also receive nelarabine IV over 2 hours once daily (QD) for 5 days and pegaspargase IV over 2 hours on day 5 after completion of course 4 and after the completion of course 5 in the absence of disease progression or unacceptable toxicity."
- "POMP maintenance therapy continues for 30 months in the absence of disease progression or unacceptable toxicity."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase 2 study tests the side effects of nelarabine with other chemotherapy drugs and how well they work. It is for people with T-cell acute lymphoblastic leukemia (ALL) or T-cell lymphoblastic lymphoma, two types of cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have T-cell ALL or T-cell lymphoblastic lymphoma that has not been treated. You may also qualify if one starting course of chemotherapy did not work, or if cancer signs are gone after no more than two courses.
- Have a score of 0 to 3 on the ECOG scale, which measures how well you can do daily activities.
- Have bilirubin, a liver-related blood test, at 2.0 mg/dL or less. Up to 5.0 mg/dL is allowed if the tumor causes the high level.
- Have liver enzyme levels (SGOT or SGPT) no more than 4 times the upper normal limit.
- Have creatinine, a blood test of kidney function, at 2.0 mg/dL or less. Up to 2.5 mg/dL is allowed if the tumor causes the high level.
Who can't join
- Are pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030Farhad Ravandi-Kashani · Study contact · 713-745-0394Farhad Ravandi-Kashani · Principal investigatorMore trials in Houston