Clinical trial · Interventional
SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
A Phase I Study of SJG-136 in Patients With Advanced Leukemia
NCT00301769CI-TRIAL-00012313terminatedPhase 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)
This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic myelogenous leukemia, or chronic lymphocytic leukemia. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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 | — | UNRESOLVED | — |
| Previously Treated Myelodysplastic Syndromes | Myelodysplastic Syndrome |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SJG-136 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.
- interventionNames
- Drug: SJG-136
Primary outcomes (1)
- 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
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of 1 of the following hematologic malignancies: * Acute myeloid leukemia * Acute lymphoblastic leukemia * Myelodysplastic syndromes * Chronic myelogenous leukemia in blastic phase * Chronic lymphocytic leukemia * Relapsed or refractory disease * No immediately available, potentially curable options (e.g., stem cell transplantation) available * Bilirubin normal (unless elevated due to Gilbert's syndrome) * HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would limit study compliance * Recovered from prior therapy * ECOG performance status =\< 2 * SGOT and SGPT =\< 2.5 times upper limit of normal (ULN) * Creatinine normal OR creatinine clearance \>= 60 mL/min * Primary resistance (i.e., failed to achieve a complete remission \[CR\] to a standard induction regimen) or relapsed after achievement of a CR. * Must have documented failure to last cytotoxic regimen prior to study entry. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * No known CNS disease * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136 * More than 7 days since radiotherapy * No concurrent combination antiretroviral therapy for HIV-positive patients * No other anti-leukemia agents except hydroxyurea =\< 5 grams/day =\< 14 days prior to and during first course of treatment to control blood counts
References
Publications (0)
Data not yet available
No reference posted for this study.