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Phone calls may boost chemo success in leukemia patients

NCT ID NCT01393366

Symptom relief Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether weekly nurse phone calls could help people with chronic lymphocytic leukemia (CLL) stick to their chemotherapy plan and reduce side effects. Sixty patients were split into two groups: one received regular care, and the other also got a weekly call to check on their health. The goal was to see if the calls helped patients get the full planned dose of their chemo drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Telephone intervention (nurse phone calls)
What this could lead to
If it works, this could show that simple phone support helps patients complete chemotherapy with fewer dose reductions and side effects.
What could go wrong
This is a small, early study with only 60 people. The phone calls may not make a meaningful difference, and results may not apply to other treatments or hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Start date

Sep 2011

Finished

Dec 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment. * Matutes score must be 4-5/5. * Initial cytopenia (due to CLL) are not exclusion criteria. * Lymph node biopsy is needed only if suspicion of Richter syndrome. * Mandatory pre-therapeutic check-up: FISH in search for deletion del17p and del11q, DAT test, haptoglobin levels, creatinine clearance. 2. Eligibility to a treatment with FCR: clearance \> 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score CIRS-G≤11. 3. Signed informed consent 4. Age\> or equal 18 years, ECOG PS 0-2. 5. Estimated overall survival\>6 months. 6. Conserved liver function (bilirubin\<2,5mg/dl, SGPT\<4ULN, SGOT\<4ULN) except infiltration due to the disease. 7. Contraception for younger patients. 8. Confident with the use of telephone, no disabling deafness. Exclusion Criteria: 1. Richter syndrome or atypical CLL (Matutes score \<4), and/or del17p by FISH 2. Relapse of CLL 3. Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance\<30 ml/mn. 4. Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection 5. Previous history of hypersensibility to any product used in this protocol 6. Denial, or medical or psychological condition preventing completion of the signed informed consent. 7. Treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study. 8. Pregnant/breastfeeding women. 9. CNS involvement by CLL. 10. Presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia

Contacts and locations

Locations

  • CH Saint Jean

    Perpignan, 66046, France

  • CHU Purpan

    Toulouse, 31059, France

  • Centre Hospitalier de la côte basque

    Bayonne, 64109, France

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