Clinical trial · Interventional
Infusional C-myb ASODN in Advanced Hematologic Malignancies
Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies
NCT00780052CI-TRIAL-00024030UPCC 04701completedPhase 1ClinicalTrials.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)
The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.
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 |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| c-myb AS ODN | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- c-myb AS ODN as a 24-hour continuous infusion over 7 days
- interventionNames
- Drug: c-myb AS ODN
Primary outcomes (1)
- measure
- Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
- timeFrame
- At study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have one of the following: acute myeloid or lymphoid leukemia; or Myeloproliferative disorder(MPD) including Chronic Myelogenous Leukemia (CML); or Myelodysplastic Syndrome (MDS); or Non-Hodgkin's Lymphoma (including CLL); or Multiple Myeloma * Patients with acute leukemia must meet one of the following conditions: \*have disease which is refractory to a course of standard induction chemotherapy \*have relapsed diseased after documentation of previous clinical remission or \*have untreated disease and not be a candidate for conventional first line treatment * Patients with CML or other MPD must have evidence of accelerated phase or blast crisis * Patients having clinical features of CML in transformation but who are negative for Philadelphia chromosome may be entered provided there is a prior definable chronic phase * Patients with Philadelphia chromosome positive CML must have failed treated with Gleevec (Imatinib) in order to be eligible for study * Patients with myelodysplastic syndrome (MDS) must have \> 5% blasts in the peripheral blood or bone marrow and have at diagnosis as IPSS score of \>= 1 * Patients with CLL must have relapsed or refractory disease after at least three courses of conventional therapy and have been determined to no longer be a candidate for conventional therapy * Patients with non-Hodgkin's lymphoma (other than CLL) must have relapsed or refractory disease after at least two courses of chemotherapy and have been determined not to be a candidate for further conventional therapies * Patients with multiple myeloma must have failed at least 3 prior therapies * Performance Status 0, 1 or 2 * Serum creatinine \< 2.0 mg/dl; serum bilirubin \< 2 mg/dl and AST/ALT \< 3.0 x upper limit of normal * PTT within normal range * Age \> 18 * Patients must have an indwelling central venous catheter Exclusion Criteria: * Significant cardiac disease which requires active therapy * Intercurrent organ damage or medical problems that will jeopardize outcome of therapy * Pregnant or lactating females * Received prior c-myb AS ODN therapy * Patients with suitable HLA identical sibling donor who are deemed to be appropriate and willing candidates for allogeneic bone marrow transplantation * Patients requiring anticoagulation with unfractionated heparin.
References
Publications (0)
Data not yet available
No reference posted for this study.