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Multi-centric Study (CHEPRALL)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2015 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01219816
First received: October 12, 2010
Last updated: December 23, 2015
Last verified: December 2015
  Purpose

Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal prognosis. In this case, allogeneic transplantation is the only curative treatment when patient have obtained a second complete remission (CR. In France, in patients younger than 60 years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In older patients (>=60 years)or young patients <= 60 years no eligible for intense chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to avoid too much toxicity but the result is worse in term of CR.

More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey, USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including 15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4 partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with acceptable toxicity. Tolerance was acceptable.

The French GRAALL group proposes to test an age-adapted combination of chemotherapy + Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis, in term of CR, survival and of number of patients eligible for allograft.


Condition Intervention Phase
B ALL CD22+ Expression Refractory B-ALL Drug: Epratuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Multicenter, Open Label, Prospective to Evaluate Efficacy and Tolerance of a Chemoimmunotherapy With HyperCVAD or Vincristine/Dexamethasone Plus the Anti-CD22 Monovlonal Antobody Epratuzumab for the Treatment of Adult Relapsed/Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients : CHEPRALL Study, a GRAALL Study.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • complete response rate (CR and CRp)

Secondary Outcome Measures:
  • Overall response rate (ORR)(CR, CRp and PR)
  • Overall survival
  • Disease free survival
  • CD22 expression after Epratuzumab
  • Safety and tolerance of Epratuzumab in combination with chemotherapy

Estimated Enrollment: 55
Study Start Date: November 2010
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients under 60 years
Hyper CVAD regimen + Epratuzumab (Cyclophosphamide Vincristine Doxorubicin Dexamethasone)
Drug: Epratuzumab
Combination of chemotherapy + Epratuzumab
Experimental: Patients older than 60 years or < =60 years
Vincristine + Aracytine + Dexamethasone
Drug: Epratuzumab
Vincristine + Dexamethasone + Epratuzumab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • B-ALL (OMs) with >= 20 % of blasts in bone marrow
  • CD22+ expression >= 30% of the blast population
  • Refractory B-ALL defined by treatment failure after 2 successive courses of induction therapy or relapse < 6 months after first CR
  • First relapse of B-ALL
  • Second relapse or beyond
  • Performance status 0-2
  • Creatinine clearance >= 50 ml/min (Cockroft formula)
  • Serum bilirubine <= 30 µmom/l
  • Written informed consent

Exclusion Criteria:

  • T-ALL
  • Meningeal involvement
  • CD22 expression on tumor cells or < 30%
  • HIV positive
  • Active Hepatitis B or C
  • Left ventricular ejection fraction < 50% in patients <60 years
  • Contra-indication to Epratuzumab
  • Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Participation at the same time in another study in which investigational drugs are used
  • Absence of written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219816

Contacts
Contact: Patrice CHEVALLIER, MD, +33(0)240083271 patrice.chevallier@chu-nantes.fr

Locations
France
Angers University Hospital Recruiting
Angers, France, 49933
Principal Investigator: Mathilde HUNAULT, MD         
University Hospital Recruiting
Caen, France, 14000
Principal Investigator: Oumedaly REMAN, MD         
HEnri Mondor Hospital Recruiting
Creteil, France, 94010
Principal Investigator: Sébastien MAURY, MD         
Edouard Herriot Hospital Recruiting
Lyon, France, 69437
Principal Investigator: Xavier THOMAS, MD         
Institut Paoli Calmette Recruiting
Marseille, France, 13373
Principal Investigator: Anne ETIENNE, MD         
Nantes University Hospital Recruiting
Nantes, France, 44000
Contact: Patrice CHEVALLIER    +33 2 40 08 32 71    patrice.chevallier@chu-nantes.fr   
Principal Investigator: Patrice CHEVALLIER, DR         
Saint Louis Hospital Recruiting
Paris, France, 75010
Principal Investigator: Herve DOMBRET, MD         
St Antoine Recruiting
Paris, France, 75015
Principal Investigator: Françoise ISNARD, MD         
Haut-Leveque Hospital Recruiting
Pessac, France, 33604
Principal Investigator: Thibaut LEGUAY, MD         
CHU de Poitiers Not yet recruiting
Poitiers, France, 86021
Principal Investigator: Maria Pilar GALLEGO, Doctor         
Purpan Hospital Recruiting
Toulouse, France, 37509
Principal Investigator: Françoise HUGUET, MD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Patrice CHEVALLIER, MD Nantes University Hospital
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01219816     History of Changes
Other Study ID Numbers: BRD 10/05-O
Study First Received: October 12, 2010
Last Updated: December 23, 2015

Keywords provided by Nantes University Hospital:
efficacy of Chemo-immunotherapy

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Vincristine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on June 26, 2017