Clinical trial · Interventional
Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia
Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia
NCT01251250CI-TRIAL-00013425withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lost sponsor support
Summary
Brief summary (as posted)
RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of Azadirachta indica in treating patients with chronic lymphocytic leukemia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage II Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage III Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage IV Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azadirachta indica | Biological | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| western blotting | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral Azadirachta indica once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: laboratory biomarker analysis
- Genetic: western blotting
- Genetic: gene expression analysis
- Other: pharmacological study
- Other: flow cytometry
- Genetic: fluorescence in situ hybridization
- Biological: azadirachta indica
- Genetic: reverse transcriptase-polymerase chain reaction
Primary outcomes (1)
- measure
- Lowest clinically active and tolerable dose
- timeFrame
- After patients have completed at least 2 treatment courses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a definitive diagnosis of CLL as defined by the IWCLL criteria * Patients may not have received any prior treatment for management of CLL; (no more than 30 patients with treatment naive disease will be included in this study) * Patients with advance stage disease (Rai Stage II-IV) may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens * Patients with relapsed or relapsed/ resistant may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens * Patients must understand and voluntarily sign an informed consent form * Have an ECOG Performance Status of =\< 2 at study entry * Able to adhere to the study visit schedule and other protocol requirements * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Hemoglobin \>= 10g/dl * Platelets \>= 50,000/mcl * Total bilirubin within normal institutional limits * AST (SGOT)/ ALT (SGPT) =\< 2.5 X institutional ULN * Patients of childbearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment * Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Trying to conceive, pregnant or breast feeding female patients * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug * Patients who are consuming other herbals or non-traditional therapies (i.e. green tea extracts and cumin) within the last 4 weeks(28 days) of initiating this clinical study; note: patient must have stopped herbal or other non-traditional therapies for CLL at least 28 days prior to initiating therapy on this study * Patients with high-risk cytogenetic (del 17p, del 11q) determined by FISH analysis * Prior organ transplant
References
Publications (0)
Data not yet available
No reference posted for this study.