Chemotherapy with nelarabine for T-cell lymphoblastic leukemia or lymphoma
Tests chemotherapy combined with nelarabine in adults with T-cell leukemia or lymphoma.
Key facts
- Who runs it
- M.D. Anderson Cancer Center
- Where
- Houston, United StatesSee the site
- Trial code
- Registry title
- Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 160 people, planned
- Started
- 11 Jul 2007
- Expected to end
- 31 Oct 2028
- Type of study
- Interventional
- Treatments tested
- Cyclophosphamide
- Cytarabine
- Dexamethasone
- Doxorubicin Hydrochloride
- Mercaptopurine
- Methotrexate
- Nelarabine
- Pegaspargase
- Prednisone
- Venetoclax
- Vincristine Sulfate
- Record updated
- 8 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who have not been treated before, or who had little treatment.
- Sex
- All sexes can join.
- Disease stage
- T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Not treated before. People whose disease did not respond to one induction course of chemotherapy can also join. People in complete remission after 2 courses or fewer can also join.
- Earlier treatment
- No earlier treatment, apart from up to 2 courses of induction chemotherapy as described above.
Main reasons for not taking part
- Pregnant or nursing women cannot join.
- ECOG performance status above 3 (the record asks for 3 or lower).
- Serum bilirubin above 2.0 mg/dL, unless caused by the tumor (then up to 5.0 mg/dL is acceptable).
- SGOT or SGPT above 4 x the upper limit of normal.
- Serum creatinine above 2.0 mg/dL (177 µmol/L), unless caused by the tumor (then up to 2.5 mg/dL (221 µmol/L) is acceptable).
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Pregnant or nursing women
Where in United States
- M D Anderson Cancer CenterHouston, United StatesContact: Farhad Ravandi-KashaniTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Treatment (nelarabine and combination chemotherapy)Treatment being tested
See Detailed Description
Treatment: Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Mercaptopurine, Methotrexate, Nelarabine, Pegaspargase, Prednisone, Venetoclax, and Vincristine Sulfate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
- Plain-language title
- Chemotherapy with nelarabine for T-cell lymphoblastic leukemia or lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 8 October 2026