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Treatment of Relapsed T-Cell Acute Lymphoblastic Leukemia or T-Lymphoblastic Lymphoma With MabCampath

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199030
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 30, 2008
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath) in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma. In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added. In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. In both arms, treatment is continued in case of response for up to two months.

Condition or disease Intervention/treatment Phase
Adult Acute Lymphocytic Leukemia T-Cell Lymphoma, Lymphoblastic Drug: Alemtuzumab (MabCampath) Drug: Cladribine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: German Multicenter Phase II Trial to Study Effectivity and Feasibility of Alemtuzumab (MabCampath®) in T-ALL and T-Lymphoblastic Lymphomas With Minimal Residual Disease (MRD), in Refractory Relapse or in Primary Failure
Study Start Date : February 2004
Study Completion Date : December 2007

Primary Outcome Measures :
  1. Arm A: rate of molecular remissions (MRD < 10(-4), toxicity according to CTC, remission duration/survival, feasibility of s.c. dose escalation and long term therapy, mortality
  2. Arm B: response (CR/PR/MR), toxicity according to CTC, SCT rate, remission duration/survival, feasibility of i.v. dose escalation/long term therapy, mortality

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

Inclusion Criteria:

Both Arms:

  • T-ALL or T-lymphoblastic lymphoma
  • CD52-expression > 20%
  • Aged >= 18 years
  • ECOG/World Health Organization (WHO) performance status 0-2
  • Life expectancy of > 2 months
  • Contraception during, and for at least 6 months after, therapy
  • At least a 2 week interval to the last cycle of chemotherapy (decision in individual cases if rapid progression)
  • No persistent toxicity from earlier cycles
  • Written informed consent

Arm 1:

  • Evidence of MRD > 10(-4) with confirmation beyond week 16 in the GMALL-Study 07/2003

Arm 2:

  • Relapse with failure to at least one salvage therapy or primary failure after induction therapy and at least one salvage therapy

Exclusion Criteria:

  • Substantial restrictions of heart, lung, liver, or kidney function
  • Active infection, HIV seropositivity or cytomegalovirus (CMV) viraemia
  • Pretreatment with MabCampath®
  • Known anaphylaxis to humanised antibodies
  • Permanent systemic therapy with corticosteroids
  • Central nervous system (CNS) involvement
  • Extramedullary bulky disease
  • Active secondary malignancies
  • Pregnancy or nursing
  • Mental disease or circumstances that prohibit compliance with the protocol procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00199030

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University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
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Study Chair: Dieter Hoelzer, MD, PhD University Hospital Frankfurt, Medical Dept. II

Additional Information:
Layout table for additonal information Identifier: NCT00199030     History of Changes
Other Study ID Numbers: GMALL07
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Keywords provided by Johann Wolfgang Goethe University Hospital:
Minimal residual disease
Lymphoma, lymphoblastic, T-cell

Additional relevant MeSH terms:
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Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasm, Residual
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs