Clinical trial · Interventional
Combination Chemotherapy in Treating Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
DFCI ALL Adult Consortium Protocol: Adult ALL Trial
NCT01005758CI-TRIAL-00013406unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of combination chemotherapy and to see how well it works in treating adult patients with newly diagnosed acute lymphoblastic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| hydrocortisone sodium succinate | Drug | — | UNRESOLVED |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility of intensification therapy, measured as the percentage of patients who, having achieved a complete remission after induction therapy, receive > 25 weeks of pegaspargase IV as part of intensification therapy
- measure
- Toxicity
Secondary outcomes (3)
- measure
- Complete remission rate
- measure
- Disease-free and overall survival
- measure
- Prognostic significance of prednisone prophase response, minimal residual disease at various time points, tyrosine kinase mutations, and gene expression profiles at diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) * No known mature B-cell ALL\*, defined by the presence of surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8) * Patients with T-cell surface markers and t(8;14)(q24;q11) are eligible NOTE: \*Patients with mature B-cell ALL will be removed from the study as soon as that diagnosis is made. * No secondary ALL (i.e., ALL arising after another malignancy) PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known HIV positivity (HIV testing is not required) * No comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives * No active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely PRIOR CONCURRENT THERAPY: * No prior anti-leukemic therapy except ≤ 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis * Patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study * No concurrent chronic steroids or anti-metabolite therapy
References
Publications (0)
Data not yet available
No reference posted for this study.