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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00147901

Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)

A Phase 2 study testing FCCam in people with B-cell Chronic Lymphocytic Leukemia, run by German CLL Study Group at 1 site in Germany.

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 study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Chronic Lymphocytic Leukemia
What is being tested?
FCCam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteGermany
Study dates
Jan 2005to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

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

  • B-CLL in need of treatment
  • One or two prior prior therapies
  • WHO performance status 0-2

Who cannot join

  • Serum creatinine > 1.5 ULN
  • Major organ dysfunctions
  • Pregnant or nursing

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Cologne

    Cologne, North Rhine-Westphalia, 50924

Other trials in Germany

About this study

Official title: Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)

This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.

Being tested
FCCam
Keywords
CLL, Immunochemotherapy
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.

  • FCCamDrug

    Also called Fludarabine, Cyclophosphamide, Alemtuzumab

    After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles

Study groups in NCT00147901
Study groupRoleWhat they receive
FCCamExperimentalAfter an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
Receives: Drug: FCCam

What is being measured

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

  1. Overall response rate (complete and partial response rate)

    Response Evaluation has to be done according the the NCI guidelines

    Measured: 28 days after the end of the last cycle

Secondary outcomes (6)

  1. Toxicity

    Measured: 28 days following the last dose of FCCam

  2. MRD response rate

    Measured: 28 days after the end of the last cycle

  3. Response rate in biological defined risk groups

    Measured: 28 days after the end of the last cycle

  4. Duration of response

    Measured: up to 36 months after the end of treatment

  5. Treatment administration (dose intensity)

    Measured: up to the last day of the last given cycle (day 28 of the 6th cycle)

  6. Overall survival

    Measured: up to 36 months after the end of treatment

Timeline

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

  1. First posted7 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionNov 2008
  4. Study completionNov 2011

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
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147901
Sponsor's protocol ID
CLL-2L
Other IDs
2005-003017-32, 2005
Status last verified
Sep 2016
First submitted
2 Sep 2005
Last updated
3 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Elter T, James R, Busch R, Winkler D, Ritgen M, Bottcher S, Kahl C, Gassmann W, Stauch M, Hasan I, Staib P, Fischer K, Fink AM, Bahlo J, Buhler A, Dohner H, Wendtner CM, Stilgenbauer S, Engert A, Hallek M. Fludarabine and cyclophosphamide in combination with alemtuzumab in patients with primary high-risk, relapsed or refractory chronic lymphocytic leukemia. Leukemia. 2012 Dec;26(12):2549-52. doi: 10.1038/leu.2012.129. Epub 2012 May 15. No abstract available.

    PubMed 22584787

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FCCam in people with B-cell Chronic Lymphocytic Leukemia, run by German CLL Study Group at 1 site in Germany.

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 3 inclusion and 3 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 3 Oct 2016. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (complete and partial response rate) (time frame: 28 days after the end of the last cycle). 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 NCT00147901, which also lists 1 linked publication.

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 3 Oct 2016.

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