Clinical trial · Interventional
Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)
- 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: Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ara-C | Drug | Cytarabine | ALIAS |
| gemtuzumab ozogamicin | Biological | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort I
- description
- Immunotherapy with gemtuzumab
- interventionNames
- Biological: gemtuzumab ozogamicin
- type
- EXPERIMENTAL
- label
- Cohort II
- description
- Gemtuzumab + ara-C
- interventionNames
- Drug: ara-C
- Biological: gemtuzumab ozogamicin
- type
- EXPERIMENTAL
- label
- Cohort IA
- description
- Gemtuzumab + ara C
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Primary refractory acute myeloid leukemia (AML)
* More than 10% blasts in the bone marrow or blood after recovery from 2 courses of standard cytarabine- and anthracycline-based induction chemotherapy
* No prior remission
* Relapsed AML
* More than 10% blasts in the bone marrow or blood after documented remission
* Prior remission lasted more than 30 days
* No prior treatment for current relapse
* CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for primary refractory patients or at the time of relapse for all other patients
* No active CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 17 and over
Performance status:
* 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
* WBC less than 30,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL
* No veno-occlusive disease of the liver
* No chronic liver disease unless due to AML
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active serious infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 6 months since prior stem cell transplantation
Chemotherapy:
* See Disease Characteristics
* Prior etoposide and/or thioguanine during remission induction allowed
* Prior hydroxyurea for control of AML allowed
* At least 24 hours since prior hydroxyurea
* At least 3 months since prior high-dose cytarabine (greater than 2 g/m\^2/dose)-containing regimen
* No other concurrent chemotherapy
Endocrine therapy:
* Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock allowed
* Concurrent ophthalmic corticosteroids allowed
* Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions) allowed
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* More than 2 months since prior cytotoxic therapyReferences
Publications (2)
- RESULTStone RM, Moser B, Sanford B, Schulman P, Kolitz JE, Allen S, Stock W, Galinsky I, Vij R, Marcucci G, Hurd D, Larson RA; Cancer and Leukemia Group B. High dose cytarabine plus gemtuzumab ozogamicin for patients with relapsed or refractory acute myeloid leukemia: Cancer and Leukemia Group B study 19902. Leuk Res. 2011 Mar;35(3):329-33. doi: 10.1016/j.leukres.2010.07.017. Epub 2010 Aug 4. PMID 20688393
- RESULTStone RM, Moser B, Schulman P, et al.: A dose escalation and phase II study of gemtuzumab ozogamicin (GO) with high-dose cytarabine (HiDAC) for patients (pts) with refractory or relapsed acute myeloid leukemia (AML): CALGB 19902. [Abstract] Blood 104 (11): A-873, 2004.