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Contiguous Stage II Small Lymphocytic LymphomaPhase 2NCT02100423

Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 2 study testing curcumin, cholecalciferol and laboratory biomarker analysis in people with Contiguous Stage II Small Lymphocytic Lymphoma and Noncontiguous Stage II Small Lymphocytic Lymphoma, run by Paolo Caimi, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies the efficacy (activity), and tolerability of curcumin and cholecalciferol combination in treating patients with previously untreated stage 0-II chronic lymphocytic leukemia or small lymphocytic lymphoma. Curcumin and cholecalciferol may prevent or slow the growth of cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
curcumin, cholecalciferol and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
16 Oct 2014to 13 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of CLL based on peripheral blood flow cytometry and/or bone marrow aspiration and biopsy OR diagnosis of SLL based on lymph node or bone marrow biopsy; patients with SLL need to have measurable disease
  • Performance status (Eastern Cooperative Oncology Group [ECOG]) 0-2
  • Patients must have not received any prior treatment for CLL or SLL
  • Patients must be stage 0-II based on Rai staging system; must have no indication for treatment for SLL per NCI-WG criteria
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
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  • Hemoglobin >= 10 g/dL
  • Serum creatinine =< 2.0 g/dL or calculated creatinine clearance (CrCl) >= 60mL/min (Cockcroft-Gault method)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (ULN)
  • Bilirubin < 2.0 x ULN, unless subject has Gilbert's disease
  • Calcium < 10.1 mg/dL (corrected to serum albumin)
  • Females will be either postmenopausal for at least 1 year or surgically sterile for at least 3 months OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
  • Able to comprehend and willing to sign an Informed Consent Form (ICF)
  • Subjects must be off any steroids 7 days prior to the initiation of treatment
  • Subjects must be off any curcumin, tumeric, or vitamin D supplements for 14 days prior to the initiation of treatment
  • Subjects must be able to take oral medications

Who cannot join

  • Presence of malignancy (other than the one treated in this study) which required systemic treatment within the past 3 years
  • Any indication to start treatment for CLL based on NCI-WG criteria
  • Prior therapy for CLL/SLL
  • Subjects who are pregnant or breast-feeding; breastfeeding should be discontinued if the mother is treated with curcumin
  • Concurrent medical condition which may increase the risk of toxicity, including:
  • Hypercalcemia of any cause
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  • Untreated hyperparathyroidism
  • Paget's disease of bone
  • Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician; subjects receiving antibiotics that are under control may be included in the study
  • Inability to take oral medications
  • Patients receiving other investigational agent
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to curcumin or vitamin D or other agents used in this study
  • Patients on therapeutic anticoagulation, with heparin (or low-molecular weight heparin), warfarin, or a direct thrombin inhibitor as the safety of concurrent administration of curcumin has not been established
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

Official title: A Phase II Study of Curcumin and Vitamin D in Previously Untreated Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

This phase II trial studies the efficacy (activity), and tolerability of curcumin and cholecalciferol combination in treating patients with previously untreated stage 0-II chronic lymphocytic leukemia or small lymphocytic lymphoma. Curcumin and cholecalciferol may prevent or slow the growth of cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the overall response rate (ORR) based on National Cancer Institute-Working Group (NCI-WG) criteria in chronic lymphocytic leukemia (CLL) or the Cheson criteria in small lymphocytic lymphoma (SLL).

SECONDARY OBJECTIVES:

  1. To determine the time to first cytotoxic treatment (TFCT), progression free survival (PFS), and overall survival (OS) using this regimen.

OUTLINE:

Patients receive curcumin orally (PO) daily on days 1-28 and cholecalciferol PO daily on days 8-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial response or better may receive treatment for a total of 2 years.

After completion of study treatment, patients are followed up for 30 days and then every 3-6 months for 2 years.

Being tested
curcumin, cholecalciferol, laboratory biomarker analysis, pharmacological study
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • curcuminDrug

    Also called C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane

    Given PO

  • cholecalciferolDietary supplement

    Also called Calciol, Vitamin D3

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT02100423
Study groupRoleWhat they receive
Treatment (curcumin, cholecalciferol)ExperimentalPatients receive curcumin PO daily on days 1-28 and cholecalciferol PO daily on days 8-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial response or better may receive treatment for a total of 2 years.
Receives: Drug: curcumin; Dietary Supplement: cholecalciferol; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)

    The point estimate of the overall response rate (biologic response rate + complete response [CR] + partial response [PR]) with 95% confidence intervals will be calculated using binomial distribution theory.

    The time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented and assessed

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Time to First Cytotoxic Treatment (TFCT)

    TFCT defined as the time from entry onto study until initiation of treatment with cytotoxic agents because of disease progression.

    Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.

    Measured: Up to 2 years

  2. Percent of Participants With Progression Free Survival (PFS)

    Percent of participants that reached 2-year survival without disease progression.

    PFS is defined as the time from entry onto study until CLL/SLL progression or death from any cause. National Cancer Institute Working Group (NCI-WG) criteria is used for CLL participants and Cheson Criteria is used for SLL participants

    Measured: Up to 2 years

  3. Overall Survival (OS)

    Number of participants still alive at 2 years after treatment discontinuation.

    Measured: Up to 2 years

  4. Duration of Response

    Time from achievement of partial response, complete response or biologic response to disease progression

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2014 (estimated)
  2. Study start16 Oct 2014
  3. Primary completion4 Apr 2018
  4. Study completion13 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02100423
Sponsor's protocol ID
CASE5913
Status last verified
Mar 2024
First submitted
27 Mar 2014
Last updated
12 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing curcumin, cholecalciferol and laboratory biomarker analysis in people with Contiguous Stage II Small Lymphocytic Lymphoma and Noncontiguous Stage II Small Lymphocytic Lymphoma, run by Paolo Caimi, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02100423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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