Clinical trial · Interventional
S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
- 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. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia. PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| tretinoin | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Induction: ATRA 45mg/m2 PO D1-CR Gemtuzumab Ozogamicin 9 mg/m2 IV D1 Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7 Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days 6-MP 60 mg/m2/d PO daily for 1 year Methotrexate 20 mg/m2 PO once/wk for 1 year
- interventionNames
- Drug: arsenic trioxide
- Drug: gemtuzumab ozogamicin
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: tretinoin
Primary outcomes (2)
- measure
- Continuous Complete Remission at 3 Years
- timeFrame
- 3 years
- description
- Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow examination * APL-RARα-negative by RT-PCR are not eligible * High-risk disease, defined as WBC \> 100,000/mm\^3 * Bone marrow specimens must be made available for cytogenetic studies PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prolonged QTc \> 0.47 sec * No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer from which the patients is currently in complete remission PRIOR CONCURRENT THERAPY: * No prior systemic chemotherapy for acute leukemia * At least 3 days since prior tretinoin (ATRA) allowed * Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed
References
Publications (1)
- DERIVEDLancet JE, Moseley AB, Coutre SE, DeAngelo DJ, Othus M, Tallman MS, Litzow MR, Komrokji RS, Erba HP, Appelbaum FR. A phase 2 study of ATRA, arsenic trioxide, and gemtuzumab ozogamicin in patients with high-risk APL (SWOG 0535). Blood Adv. 2020 Apr 28;4(8):1683-1689. doi: 10.1182/bloodadvances.2019001278. PMID 32330241