Clinical trial · Interventional
XK469R in Treating Patients With Refractory Hematologic Cancer
A Phase I Study of XK469R (NSC 698215) in Patients With Refractory Hematologic Malignancies
NCT00095797CI-TRIAL-00009366completedPhase 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)
Phase I trial to study the effectiveness of XK469R in treating patients who have refractory hematologic cancer. Drugs used in chemotherapy, such XK469R, work in different ways to stop cancer cells from dividing so they stop growing or die
Conditions
Conditions (29)
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 Basophilic Leukemia | Adult Acute Basophilic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Eosinophilic Leukemia | — | UNRESOLVED | — |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation | ALIAS | 0.90 |
| Adult Acute Myeloblastic Leukemia Without Maturation (M1) |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| R(+)XK469 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (XK469R)
- description
- Patients receive XK469R IV over 30-60 minutes on days 1, 3, and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: R(+)XK469
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- MTD as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- timeFrame
- 21 days
- measure
- Dose-limiting toxicity (DLT) defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications using CTCAE version 3.0
- timeFrame
- 21 days
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of 1 of the following relapsed or refractory hematologic malignancies for which all potentially curative therapy options have been exhausted:
* Acute myeloid leukemia\* (AML) (non-M3)
* Acute lymphoblastic leukemia\*
* Myelodysplastic syndromes\*, including the following:
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia in transformation\* (CMML-t) with ≥ 10% peripheral blood/bone marrow blasts
* Chronic myelogenous leukemia in blast crisis\* (CML-BC)
* Chronic lymphocytic leukemia
* Rai stage III-IV
* Failed prior fludarabine-based therapy and ≥ 1 other therapy
* Fludarabine failure defined as failure to achieve partial response or complete response (CR) to at least 1 fludarabine-containing regimen; disease progression while on fludarabine; or disease progression within 6 months of response to fludarabine
* Not a candidate for autologous or allogeneic stem cell transplantation (SCT)
* Patients with previously untreated AML, MDS, or CMML-t who are considered inappropriate candidates for, or refused, standard induction chemotherapy due to older age or concurrent medical conditions are eligible
* No known CNS disease
* Performance status - ECOG 0-2
* See Disease Characteristics
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 5 times ULN
* Creatinine \< 1.5 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to XK469R
* No other uncontrolled illness
* HIV-positive patients allowed provided CD4 counts are normal with no AIDS-defining disease
* No prior allogeneic SCT
* No concurrent prophylactic hematopoietic colony-stimulating factors
* More than 7 days since prior cytotoxic chemotherapy (except hydroxyurea)
* More than 7 days since prior radiotherapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anti-leukemia agents
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.