Clinical trial · Interventional
Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone ("ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia. PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and comparing them to see how well they work in treating adults with acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dactinomycin | Biological | Dactinomycin | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARA-C/High-Dose Mitoxantrone("All-2")
- description
- See detail description
- interventionNames
- Biological: dactinomycin
- Biological: sargramostim
- Drug: carmustine
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: mitoxantrone hydrochloride
- Drug: pegaspargase
- Drug: prednisone
- Drug: vincristine sulfate
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Standard Vincristine/Prednisone ("L-20")
- description
- See detail description
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of one of the following malignancies: * Acute lymphoblastic leukemia (ALL) of B- or T-cell lineage * Philadelphia chromosome-positive ALL eligible * Lymphoblastic lymphoma * Chronic myelogenous leukemia in lymphoid blast crisis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 20-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 mg/dL * Glucocorticoids for higher bilirubin allowed prior to entry, at principal investigator's discretion Renal: * Creatinine no greater than 2.0 mg/dL * Glucocorticoids or renal radiotherapy for higher creatinine allowed prior to entry, at principal investigator's discretion Cardiovascular: * Left ventricular ejection fraction at least 50% Other: * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy Chemotherapy * No prior chemotherapy Endocrine therapy * No prior endocrine therapy Radiotherapy * No prior radiotherapy Surgery * No prior surgery
References
Publications (0)
Data not yet available