New hope for young leukemia patients: combination chemo shows promise
NCT ID NCT00558519
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested a combination of chemotherapy drugs in 318 adolescents and young adults (ages not specified but typically 15-39) with newly diagnosed acute lymphoblastic leukemia (ALL). The goal was to see how well the treatment worked at killing cancer cells and stopping the disease from coming back. Participants received multiple chemotherapy drugs over several phases, and researchers measured response rates, survival, and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
318 people
The number who actually took part.
- Started
-
Mar 2008
- Finished
-
Jun 2024
- Lead sponsor
-
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
-
16 to 39 years
- Sex
-
Anyone
- Healthy volunteers
-
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.
Eligibility Criteria: 1. Diagnosis 1. Newly diagnosed patients with either B-precursor or T-precursor acute lymphoblastic leukemia (WHO criteria). Burkitt type leukemia as defined per protocol is not eligible. Patients known to have Ph+ ALL at time of diagnosis are not eligible. 2. CALGB patients entered on CALGB 10403 who are later found to meet the following criteria for Ph+ ALL should have treatment on this trial discontinued and should be encouraged to enroll on CALGB 10001 or its successor trial: * BCR-ABL fusion transcript determined by FISH or RT-PCR * t(9;22)(q34;q11) or variant determined by cytogenetics Non-CALGB study participants who are later found to be Ph+ should have treatment on this trial discontinued and should be encouraged to enroll on an appropriate clinical trial specifically designed for Ph+ ALL. 2. Age: 16 - 39 years 3. ECOG Performance Status 0-2 4. Patients with Down Syndrome are excluded from this study due to the likelihood of excessive toxicity resulting. These patients should be treated in consultation with a pediatric oncologist. 5. Prior Therapy - No prior therapy except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. 1. No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC. 2. Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systemic therapy for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy. 3. Patients receiving prior steroid therapy are eligible for study. The dose and duration of previous steroid therapy should be carefully documented on case report forms.
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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.
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Other studies related to the condition(s) this trial covers.
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