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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199030
First Posted: September 20, 2005
Last Update Posted: May 30, 2008
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.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
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 Intervention Phase
Adult Acute Lymphocytic Leukemia T-Cell Lymphoma, Lymphoblastic Drug: Alemtuzumab (MabCampath) Drug: Cladribine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • 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
  • 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

Estimated Enrollment: 25
Study Start Date: February 2004
Estimated Study Completion Date: December 2007
  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00199030


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00199030     History of Changes
Other Study ID Numbers: GMALL07
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: May 30, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Lymphoma
Leukemia
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
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Alemtuzumab
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs