Clinical trial · Interventional
Study of DT388GMCSF Fusion Protein in Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML)
A Phase I Study of DT388GMCSF Fusion Protein in Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
DTGM belongs to a new generation of drugs designed to target leukemic cells. To achieve this, DTGM takes advantage of the ability of naturally-produced growth factor (GM, granulocyte-macrophage stimulating factor) to deliver a drug (diphtheria toxin) to cells; preferably leukemic cells. It then attaches to the cells and allows the toxin to enter the leukemic cells and destroy them.
Conditions
Conditions (2)
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 Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DTGM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DTGM
- description
- Starting dose of DTGM fusion protein 2 mcg/kg/day as a short (30 min) intravenous infusion, three times /week (M,W,F) for two consecutive weeks. In absence of defined grade 3/4 nonhematological toxicities in the first 0/3 or 1/6 patients, the dose will be escalated by 1 mcg/kg/day for the next patient cohort.
- interventionNames
- Drug: DTGM
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with refractory or relapsed AML ( marrow blasts \> 20% ), must have failed induction therapy or have relapsed after CR duration \< 6 months following induction therapy, untreated or refractory to salvage chemotherapy. Relapsed AML patients with CR duration \> 6 months or previously untreated patients refusing chemotherapy and not considered for treatments of higher priority are also eligible. * Patients with chronic myelomonocytic leukemia (CMML) who failed at least one course of chemo- or biological therapy( including trial of erythropoietin), or patients with relapsed CMML. Previously untreated CMML patients with HB \< or = 12 g / dL, not eligible for protocols of higher priority or not wishing to receive chemotherapy. * Patients must have an ECOG performance status of \< 2. * Patients must have WBC count \< 10,000/mL prior to initiating the treatment. The WBC count must be stabilized below this level for at least three days by leukopheresis or hydroxyurea. Hydroxyurea must be discontinued one day prior to initiation of DT388GMCSF treatment. * Patients must have creatinine \< 1.6 times ULN: bilirubin \<1.6 times ULN; SGPT \< 2.6 x ULN; albumin \> 3 gm/dl; adequate cardiac function (EF \>44%), oxygen saturation \> 92% without exogenous oxygen administered. * Patients must be willing to be treated at M D Anderson Cancer Center. * Women of childbearing potential and men must agree to practice contraception using approved methods. * No chemotherapy except Hydroxyurea 2 weeks prior to entering the study and recovered from previous toxicity. * Patients must be \> 17 years old. Exclusion Criteria: * Patients with serious concurrent medical problems. Patients with proven bacterial infections are not eligible until the resolution of the infection (patient afebrile who completed antibacterial therapy, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and fever does not exceed 38C for at least 2 days. * Inability to give informed consent because of psychiatric problems or other serious medical problems. * Pregnant or nursing women. * Patients with documented CNS leukemia or leukemia with CNS symptoms. * Patients who have had a myocardial infarction within the past six months. * Patients with severe penicillin allergy (anaphylaxis). * Not fully recovered from toxic effects of prior chemotherapy or radiation therapy. * Patients who are on corticosteroid treatment for any medical condition.
References
Publications (0)
Data not yet available