Clinical trial · Interventional
Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- 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)
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- At 2 years from study entry
Secondary outcomes (3)
- measure
- Number of Serious Adverse Events Within 2 Years
- timeFrame
- At 2 years from study entry
- measure
- Duration of Response
- timeFrame
- At 2 years from study entry
- description
- Participants who responded to treatment
- measure
- Duration of Survival
- timeFrame
- At 2 years from study entry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria: * At least 20% of blasts in the bone marrow * AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen * No acute promyelocytic leukemia * No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders * No active CNS leukemia PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy ≥ 4 weeks * Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)\* * AST and ALT ≤ 2.5 times ULN\* * Serum creatinine ≤ 1.0 mg/dL\* OR estimated glomerular filtration rate \> 60 mL/min * No active uncontrolled systemic infection * No concurrent active malignancy * No HIV positivity * No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: \*Unless due to organ leukemic involvement PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior myelosuppressive chemotherapy * At least 48 hours since prior hydroxyurea * No prior clofarabine or temsirolimus * No prior allogeneic stem cell transplantation * No investigational drug within the past 30 days
References
Publications (0)
Data not yet available