New combo therapy aims to crush T-Cell blood cancers
NCT ID NCT00501826
First seen Jun 24, 2026 · Last updated Jul 16, 2026 · Updated 3 times
Summary
This phase II trial is testing a combination of chemotherapy drugs plus nelarabine in 160 people with previously untreated T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. The goal is to see if this stronger cocktail can improve remission rates and help people live longer without the cancer coming back. Researchers are also closely watching for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- combination chemotherapy (cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, venetoclax)
- What this could lead to
- If successful, this could offer a more effective treatment option for people with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma, potentially improving remission rates and long-term survival.
- What could go wrong
- This is a phase II trial, so it is still early. The combination may cause significant side effects, and it is not yet known if it will be better than standard treatments. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2007
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a smart chemotherapy outsmart resistant T-Cell cancers?
- A pill after transplant: new hope to stop t-cell cancer relapse
- Personalized chemo dosing may boost survival in kids with High-Risk leukemia
- Engineered immune cells take aim at Hard-to-Treat T-Cell cancers
- Engineered immune cells take aim at stubborn blood cancers
- Double-Barreled immune attack aims to wipe out T-ALL