Clinical trial · Interventional
Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia
A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
NCT00087204CI-TRIAL-00009054completedPhase 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 rebeccamycin analog in treating patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast phase. Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop cancer cells from dividing so they stop growing or die
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 |
|---|---|---|---|
| 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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| becatecarin | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (becatecarin)
- description
- Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 1 additional course beyond CR. Patients achieving a PR or HI receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the 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.
- interventionNames
- Drug: becatecarin
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Maximum tolerated dose of becatecarin
- timeFrame
- 21 days
- description
- Graded using the NCI CTCAE version 3.0.
Secondary outcomes (5)
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
* Myelodysplastic syndromes, including 1 of the following:
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts
* Acute lymphoblastic leukemia
* Chronic myelogenous leukemia in blastic phase
* Relapsed or refractory disease, defined as 1 of the following:
* Failed to achieve a complete response (CR) to a standard induction regimen
* Relapsed after achieving a CR
* Failed last cytotoxic regimen before study entry
* No alternate, potentially curative option available
* No known CNS disease
* Performance status - ECOG 0-2
* SGOT and SGPT normal
* Bilirubin normal
* Creatinine normal
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119)
* No concurrent uncontrolled illness
* No active or ongoing infection
* No psychiatric illness or social situation that would preclude study compliance
* No prior allogeneic stem cell transplantation
* No concurrent prophylactic hematopoietic colony-stimulating factors (CSF)
* No epoetin alfa or hematopoietic CSF during course 1 of study therapy
* More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea
* More than 7 days since prior radiotherapy
* Recovered from all prior therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer agents or therapies
* No other concurrent antileukemic agents or therapies
* No other concurrent investigational agents or therapies
* No other concurrent cytotoxic agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.