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Chronic Lymphocytic LeukaemiaPhase 2R-CHOPNCT00504491

R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Rituximab-CHOP-Alemtuzumab in people with Chronic Lymphocytic Leukaemia and Patients Resistant to a Purine Analogous, run by CABYC at 32 sites in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Since there is no standard rescue therapy for refractory CLL or relapsed to the purine analogous, our target is to carry out a rescue therapy combining several chemotherapy agents (CHOP) adding the synergistic effect of Rituximab in order to act against tumour-like CLL forms, with assessable size lymph nodes. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Rituximab-CHOP-Alemtuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
32 sitesSpain
Study dates
Jul 2007to Jun 2012
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient's written informed consent before initiation of any specific procedure related with the study.
  • Age ≥ 18 years and ≤ 70 years
  • (ECOG) ≤ 2
  • Patients suffering from chronic lymphocyte leukaemia according to the established diagnostic criteria (Addendum A).
  • Active CLL defined by the presence of one or more of the following criteria:
  • Related symptoms: weight loss >10% in the 6 previous months, or fever >38ºC for 2 weeks with no evidence of infections, or extreme fatigue, or night sweats with no evidence of infection.
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  • 5.2.Enlarged lymph nodes or giant node clusters (>10 cm in diameter) or progressive growth lymph nodes.
  • 5.3.Giant splenomegaly (> 6 cm under ribs border) or progressive splenomegaly.
  • 5.4.Progressive lymphocytosis (>50% increase in a period of 2 months) or lymphocyte duplication time (expected) < 6 months
  • 5.5.Proof of progressive bone marrow failure evidenced by development or worsening of anaemia and/or thrombopenia.
  • Patients previously treated in first line with purine analogous and showing:
  • Treatment failure (stable disease or progression)
  • Relapse within three years of therapy.
  • Agreement to use a high efficacy contraception method throughout all study period.

Who cannot join

  • Age > 70 years
  • Patients having received more than one therapy line
  • Patients that had not received previously purine analogous therapy.
  • CLL patients in transformation to more aggressive cytologic or pathologic forms (Pro-lymphocytic leukaemia large cell lymphoma, Hodgkin's lymphoma)
  • Hypersensitivity shown as anaphylactic reaction to any of the DRUGS used in the trial.
  • Patients with severe heart, lung, neurological, psychiatric or metabolic diseases not due to CLL
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  • Patients under systemic and continued steroid therapy.
  • Impairment of renal function (Creatinine > 2 times the upper limit of normal) non-attributable to CLL.
  • Patients suffering anaemia or thrombocytopenia of autoimmune origin as well as those with a positive Coombs test
  • Impairment of liver function (Bilirubin, ASAT/ALAT or Gamma-GT > 2 times upper limit of normal) non attributable to CLL
  • Patients with active severe infectious disease
  • Patients suffering another malignancy (with the exception of focalized skin carcinoma)
  • Patients with positive serum tests for HBsAg or CHV
  • Patients with history of HIV or other severe immune depression conditions.
  • Pregnant or breast feeding women
  • Patients unable to attend the controls under outpatient regimen
  • Patients previously treated with alemtuzumab

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Spain32 sites

  • ICO Badalona

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Valle de Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clinic i Provincial.

    Barcelona, Catalonia, 08036

  • Hospital de Basurto

    Bilbao, Bilbao, 48013

  • Hospital Francisco de Borja

    Gandia, Valencia, 46700

  • ICO Gerona

    Girona, Girona, 17007

  • Hospital Virgen de las Nieves

    Granada, Granada, 18014

  • ICO Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Arnau de Vilanova

    Lleida, Lleida, 25198

  • Hospital La Princesa

    Madrid, Madrid, 28006

  • Hospital Gregorio Marañon

    Madrid, Madrid, 28007

  • M.D.Anderson Internacional

    Madrid, Madrid, 28033

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital 12 de octubre

    Madrid, Madrid, 28041

  • Althaia

    Manresa, Barcelona, 08243

  • Hospital Morales Meseguer

    Murcia, Murcia, 30008

  • Hospital de Son Dureta

    Palma de Mallorca, Balearic Islands, 07014

  • Corporacion Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Clinico de Salamanca

    Salamanca, Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Gran Canaria, 38320

  • Hospital Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Santiago de Compostela, 36680

  • Hospital Virgen del Rocio

    Seville, Sevilla, 41013

  • Hospital Joan XXIII

    Tarragona, Tarragona, 43005

  • Hospital La Fe

    Valencia, Valencia, 46009

  • Hospital Clinico de Valencia

    Valencia, Valencia, 46011

  • Hospital Doctor Peset

    Valencia, Valencia, 46017

  • Hospital General de Valencia

    Valencia, Valencia, 46018

  • Hospital Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Rescue Treatment With Rituximab-CHOP Therapy and Alemtuzumab (R-CHOP-A) in Refractory or Recidivant Patients With Chronic Lymphocytic Leukemia After Purine-analogous Treatment

Since there is no standard rescue therapy for refractory CLL or relapsed to the purine analogous, our target is to carry out a rescue therapy combining several chemotherapy agents (CHOP) adding the synergistic effect of Rituximab in order to act against tumour-like CLL forms, with assessable size lymph nodes. Afterwards, based in other studies, we shall study the role of Alemtuzumab as drug for consolidation or improvement of responses obtained with the initial therapy (CHOP-R), acting by "cleaning" from peripheral blood and bone marrow the CLL lymphocytes that may have had remain as residual after chemotherapy induction therapy. More precisely, the addition of Alemtuzumab as maintenance treatment would increase the complete responses with negative residual disease number and may prolong the duration of the response. For this, it is necessary to have not only an adequate and rigorous clinical follow-up but also biological, i.e. being able to analyze minimal residual disease by molecular biology techniques. This is the reason of writing this phase II clinical trial protocol.

Read the detailed description

OBJECTIVES

The objectives of this clinical trial are the following:

  • Main objective of the study: Overall response rate obtained after R-CHOP regime followed by Alemtuzumab consolidation as second line therapy
  • Secondary objectives
  • Determine the molecular complete response rate after R-CHOP regimen
  • Determine the efficacy of Alemtuzumab in response improvement after R-CHOP regimen: conversion of PR to CR and of MRD+ to MRD-.
  • Applicability (toxicity profile) of Alemtuzumab consolidation therapy.
  • As additional objectives will be considered:
  1. Prognostic value of several biological variables (ZAP-70 and cytogenetics) having influence on the response
  2. Response duration
  3. Progression free survival
  4. Overall survival
Being tested
Rituximab-CHOP-Alemtuzumab
Keywords
Rituximab-CHOP, Alemtuzumab, Chronic lymphocytic leukaemia
Medical subject headings
Leukemia, B-Cell

What participants receive

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

  • Rituximab-CHOP-AlemtuzumabDrug

    Four Rituximab - CHOP courses will be given The courses will be given every 21 days

Study groups in NCT00504491
Study groupRoleWhat they receive
1ExperimentalFour Rituximab - CHOP courses will be given The courses will be given every 21 days Drug Dose Day Rituximab (Mabthera) 500mg/m2 1(*) (**) Cyclophosphamide 750mg/m2 1 Adriamycin 50mg/m2 1 Vincristine 1,4 mg/m2 1 Prednisone 60mg/m2 1 to 5 (**) 1st course, 375 mg/m2 (*) If lymphocyte count is > 30 X 10 9/l, dose will be split up in two, which will be given in days 0 and 1
Receives: Drug: Rituximab-CHOP-Alemtuzumab

What is being measured

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

  1. Response rate obtained after R-CHOP regimen followed by consolidation therapy with Alemtuzumab, as second line therapy. Haematological and non haematological toxicity will be graded in accordance with the WHO system

    Measured: 57 months

Timeline

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

  1. First posted20 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJan 2012 (estimated)
  4. Study completionJun 2012 (estimated)

Why it stopped: IMP new owner decision

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00504491
Sponsor's protocol ID
GELLC-2
Other IDs
2007-003097-26
Acronym
R-CHOP
Status last verified
Dec 2011
First submitted
19 Jul 2007
Last updated
30 Dec 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab-CHOP-Alemtuzumab in people with Chronic Lymphocytic Leukaemia and Patients Resistant to a Purine Analogous, run by CABYC at 32 sites in Spain.

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 14 inclusion and 17 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: withdrawn, as of the sponsor's last update on 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Spain. 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 was withdrawn before enrolling participants, so there are no results.

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?

Response rate obtained after R-CHOP regimen followed by consolidation therapy with Alemtuzumab, as second line therapy. Haematological and non haematological toxicity will be graded in accordance with the WHO system (time frame: 57 months). 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 NCT00504491.

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 30 Dec 2011.

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