Clinical trial · Interventional
GTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade Myelodysplastic Syndromes, or Refractory or Blastic Phase Chronic Myelogenous Leukemia
Phase I and Pharmacodynamic Study of GTI-2040 (NSC 722929, IND 67368) in Acute Leukemias
- 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)
This phase I trial is studying the side effects and best dose of GTI-2040 in treating patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic syndromes, or refractory or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as GTI-2040, work in different ways to stop the growth of cancer or abnormal cells, either by killing the cells or by stopping them from dividing.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Undifferentiated Leukemia | Acute Undifferentiated Leukemia | ONTOLOGY_EXACT | 0.90 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ALIAS | 0.85 |
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| de Novo Myelodysplastic Syndromes | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GTI-2040 | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Procedure | — | UNRESOLVED |
| pharmacological study | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive GTI-2040 IV continuously on days 1-4 and 15-18.
- interventionNames
- Drug: GTI-2040
- Procedure: pharmacological study
- Procedure: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
- timeFrame
- 28 days
- measure
- Change in dCTP levels in PBMC and bone marrow by Real-Time PCR
- timeFrame
- Days 1, 4, 15, and 19 of course 1
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of 1 of the following: * Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) refractory to primary standard induction therapy * Relapsed or refractory acute leukemia * Chronic myelogenous leukemia (CML) in blast crisis at diagnosis OR that failed prior aggressive induction chemotherapy * Diagnosis of 1 of the following: * Acute leukemia secondary to preexisting hematologic condition or prior chemotherapy at diagnosis OR that failed prior aggressive induction chemotherapy * Advanced myelodysplastic syndromes (intermediate-1 or greater) * De novo acute leukemia (myeloid or nonmyeloid) * Not a candidate for aggressive standard induction chemotherapy * De novo AML or ALL (patients \> 60 years of age) * No suspected or proven active CNS leukemia * ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100% * Life expectancy \>= 8 weeks * Bilirubin =\< 1.5 mg/dL * AST and ALT \< 3 times upper limit of normal (ULN) * Creatinine =\< 1.5 times ULN * No HIV positivity * Fertile patients must use effective contraception * No history of allergic reactions attributed to other phosphorothiolated oligonucleotides * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing, active, or poorly controlled infection * Symptomatic congestive heart failure * Unstable angina pectoris * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Cardiac arrhythmia * Poorly controlled pulmonary disease * Psychiatric illness or social situation that would preclude study compliance * Recovered from all prior therapies * Prior autologous or allogeneic stem cell transplantation allowed (No active graft-vs-host disease \> grade 2) * At least 2 weeks since prior and no concurrent cytotoxic chemotherapy * At least 2 weeks since prior and no concurrent biologic therapy * At least 2 weeks since any other prior investigational agent * No other concurrent anticancer therapy, including radiotherapy or hormonal therapy * Concurrent imatinib mesylate for CML allowed * Not pregnant or nursing * Negative pregancy test
References
Publications (0)
Data not yet available