CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
filgrastim +2 morebiological
Likely dose
Cytarabine dose not specified in published record; bismuth Bi-213 monoclonal antibody M195 dose not specifiedAI-extracted
Key inclusion· 5
  • ✓Pathologically confirmed AML that is newly diagnosed (age >60, not eligible for higher priority protocols), newly diagnosed (unable to receive anthracycline or high-dose cytarabine), in relapse, or refractory to two courses of standard induction chemotherapy or one course of high-dose cytarabine induction
  • ✓CML 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
Key exclusion· 7
  • ✕Active CNS leukemia
  • ✕New York Heart Association class III or IV cardiac disease
  • ✕Pulmonary disease
  • ✕Detectable antibodies to monoclonal antibody M195

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00014495
NCT00014495Phase 2Completed
CompareCT.gov

Phase I/II Trial Of Sequential Therapy With Cytarabine And Bismuth-213-Labeled HuM195 (Humanized Anti-CD33) In Patients With Advanced Myeloid Malignancies

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 27, 2003·Updated Jan 22, 2016

In Brief

A Phase 2 clinical trial evaluating filgrastim, cytarabine, and 1 other intervention for Leukemia and 2 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 1, 2000
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

cytarabinedrug

bismuth Bi213 monoclonal antibody M195radiation