Clinical trial · Interventional
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
Phase I/II Trial Of Sequential Therapy With Cytarabine And Bismuth-213-Labeled HuM195 (Humanized Anti-CD33) In Patients With Advanced Myeloid Malignancies
NCT00014495CI-TRIAL-00020624completedPhase 1 / Phase 2Results postedClinicalTrials.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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer.
Conditions
Conditions (3)
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 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bismuth Bi213 monoclonal antibody M195 | Radiation | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bismuth Bi 213 monoclonal antibody M195 & cytarabine
- description
- Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD. Patients are followed twice weekly for 4 weeks and then monthly for 3 months
- interventionNames
- Biological: filgrastim
- Drug: cytarabine
- Radiation: bismuth Bi213 monoclonal antibody M195
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 2 years
- description
- The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Pathologically confirmed acute myeloid leukemia (AML) meeting one of the following criteria:
* Newly diagnosed AML, over age 60, and not eligible for higher priority protocols
* Newly diagnosed AML and unable to receive anthracycline-containing or high-dose cytarabine-containing regimens
* AML in relapse
* AML refractory to two courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy
* Chronic myelogenous leukemia in accelerated phase or myeloid blast crisis
* Refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia
* More than 25% of bone marrow blasts must be CD33 positive
* Not a candidate for immediate bone marrow transplantation with a HLA-compatible donor
* No active CNS leukemia
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2 mg/dL (unless due to leukemia or Gilbert's disease)
* Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
Renal:
* Creatinine less than 2 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV cardiac disease
Pulmonary:
* No pulmonary disease
Other:
* No detectable antibodies to monoclonal antibody M195
* No serious active uncontrolled infection
* No other concurrent active malignancy requiring therapy
* No other serious or life-threatening conditions that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic therapy and recovered
Chemotherapy:
* See Disease Characteristics
* Prior hydroxyurea allowed if discontinued before study treatment
* At least 3 weeks since other prior chemotherapy and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 3 weeks since prior radiotherapy and recovered
Surgery:
* Not specifiedReferences
Publications (2)
- RESULTRosenblat TL, McDevitt MR, Mulford DA, Pandit-Taskar N, Divgi CR, Panageas KS, Heaney ML, Chanel S, Morgenstern A, Sgouros G, Larson SM, Scheinberg DA, Jurcic JG. Sequential cytarabine and alpha-particle immunotherapy with bismuth-213-lintuzumab (HuM195) for acute myeloid leukemia. Clin Cancer Res. 2010 Nov 1;16(21):5303-11. doi: 10.1158/1078-0432.CCR-10-0382. Epub 2010 Sep 21. PMID 20858843
- RESULTMulford DA, Pandit-Taskar N, McDevitt MR, et al.: Sequential therapy with cytarabine and bismuth-213 (213Bi)-labeled-HuM195 (Anti-CD33) for acute myeloid leukemia (AML). [Abstract] Blood 104 (11): A-1790, 2004.