Clinical trial · Interventional
Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)
- 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)
The goal of this clinical research study is to find the highest tolerable dose of the drugs clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or refractory ALL. The safety of the combination treatment will also be studied. Objectives: Phase I: 1. To establish toxicities and safety of the proposed combination 2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination to proceed with the phase II part of the study Phase II: 3. To establish the efficacy (complete and overall response) of the proposed combination. 4. To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination.
Conditions
Conditions (3)
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Burkitt's Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine + Cyclophosphamide
- description
- Clofarabine 40 mg/m\^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m\^2 every 12 hours for 3 days
- interventionNames
- Drug: Clofarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Maximum Tolerated Dose for Cyclophosphamide (MTD)
- timeFrame
- First 14 days of each cycle
- description
- MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/\> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. For patients in first relapse, the first remission duration may not exceed 12 months. 2. Age \>/= 21 years. 3. Zubrod performance status \</= 3. 4. Adequate liver function (bilirubin \</= 2.5 mg/dL and Serum glutamic pyruvic transaminase (SGPT or SGOT) \</= 3 \* ULN, unless considered due to tumor), and renal function (glomerular filtration rate \[GFR\] \>/= 60 mL/min). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \</= 5 mg/dL and creatinine \</= 3 mg/dL. 5. Male and female patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as \>/= 1 year postmenopausal or surgically sterilized). Exclusion Criteria: 1. Patients with active heart disease (New York Heart Association (NYHA) class \>/= 3 as assessed by history and physical examination). 2. Patients with a cardiac ejection fraction (as measured by either Multi Gated Acquisition Scan (MUGA) or echocardiogram) \< 45% are excluded. 3. Patients who receive other chemotherapy. Patients must have been off previous therapy for \>/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. (Concurrent therapy for central nervous system (CNS) prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition following discussion with the Principal Investigator. 4. Pregnant and breast-feeding patients are excluded
References
Publications (0)
Data not yet available